Use of rehydration salts in the treatment of migraine headaches

Abstract

Use of rehydration salts in the treatment and / or prevention of neurological disorders, e.g., migraine headaches. The rehydration salts may be dissolved to produce a rehydration solution for administration to a subject in need thereof to increasing the sodium levels in the subject.

Description

[0001] USE OF REHYDRATION SALTS IN THE TREATMENT OF MIGRAINE

[0002] HEADACHES

[0003] RELATED APPLICATIONS

[0004] This application claims the benefit of priority under 35 USC §119(e) of U.S. Provisional Patent Application No. 63 / 614,931 filed 12 / 27 / 2023, the contents of which are incorporated herein by reference in their entirety.

[0005] FIELD AND BACKGROUND OF THE INVENTION

[0006] The present invention, in some embodiments thereof, relates to treatment and / or prevention of migraine headaches, and, more particularly, but not exclusively, to increase sodium levels in a subject in need thereof.

[0007] The American Migraine Prevalence and Prevention (AMPP) study reported a cumulative incidence of lifetime migraine in 43% of women and 18% of men, making it one of the most common disabling conditions.

[0008] Scientific literature has extensively explored the relationship between sodium levels, gender differences, and migraine susceptibility. Studies consistently highlight that females often exhibit lower baseline sodium levels compared to males, a phenomenon influenced by hormonal fluctuations, particularly those associated with the menstrual cycle. Estrogen, a pivotal reproductive hormone in females, has been implicated in modulating sodium homeostasis. Its cyclic variations throughout the menstrual cycle may contribute to sodium level fluctuations.

[0009] Therefore, there is a need for an effective method of treatment and / or prevention of migraine headaches.

[0010] SUMMARY OF THE INVENTION

[0011] According to an aspect of some embodiments of the invention, there is provided a rehydration solution for use in the prevention and treatment of neurological disorders.

[0012] According to some embodiments of the invention, the neurological disorder is selected from headaches, migraine with aura, migraine without aura, chronic migraine, migraine with brainstem aura, vestibular migraine, abdominal migraine, hemiplegic migraine, and menstrual migraine.

[0013] According to some embodiments of the invention, the neurological disorder is characterized by a warning sign selected from the group consisting of: headache; sensitivity to light, sound or smell; visual disturbances; tingling sensations in the extremities; cognitive dysfunction; fatigue; irritability; mood swings; depression; anxiety; allodynia; dizziness; nausea; vomiting; constipation; diarrhea; food cravings; food aversions; frequent yawning; neck stiffness; and difficulty concentrating.

[0014] According to some embodiments of the invention, the rehydration solution is administered to a subject having at least one of the following risk factors: a change in estrogen level, an expected change in estrogen level, increase in stress, certain weather conditions, and starting various medications.

[0015] According to some embodiments of the invention, the rehydration solution includes sodium chloride.

[0016] According to some embodiments of the invention, the rehydration solution for use further includes potassium chloride.

[0017] According to some embodiments of the invention, the rehydration solution for use further includes glucose.

[0018] According to some embodiments of the invention, the rehydration solution for use further includes trisodium citrate dihydrate.

[0019] According to some embodiments of the invention, the salts and the glucose are dissolved in about 1 liter of water.

[0020] According to some embodiments of the invention, the rehydration solution for use includes: between 45 to 90 mmol / 1 Sodium; between 20 to 40 mmol / 1 Potassium; and between 20 to 40 g / 1 Glucose.

[0021] According to some embodiments of the invention, the rehydration solution further includes magnesium.

[0022] According to some embodiments of the invention, the magnesium is at a concentration of between 25 to 200 mg / 1 magnesium.

[0023] According to some embodiments of the invention, the rehydration solution further includes: calcium.

[0024] According to some embodiments of the invention, the calcium is at a concentration of between 25 to 600 mg / 1 magnesium. According to an aspect of some embodiments of the invention, there is provided a method for the prevention and treatment of neurological disorders, the method including: administering to a subject in need thereof multiple doses of a rehydration solution over a predetermined period of time.

[0025] According to some embodiments of the invention, the dosage of rehydration solution is tapered over time.

[0026] According to some embodiments of the invention, the dosage of rehydration solution for treatment and / or prevention of migraines includes an initial regime, a second regime after the first regime, and a third regime after the second regime.

[0027] According to some embodiments of the invention, the second regime includes a dose ranging between 1 / 3 to 3 / 4 of the dose during the first regime.

[0028] According to some embodiments of the invention, the third regime includes a dose ranging between 1 / 3 to 3 / 4 of the dose during the second regime.

[0029] According to some embodiments of the invention, length of the second regime ranges between 1 / 3 to 3 times the length of the first regime.

[0030] According to some embodiments of the invention, length of the third regime ranges between 1 / 3 to 3 times the length of the second regime.

[0031] According to an aspect of some embodiments of the invention, there is provided a method for the prevention and treatment of neurological disorders, the method including: replacing 80 to 100% of a subject’s water intake with a rehydration solution for a period of up to 14 days, wherein the dehydration solution includes a sodium supplement; and tapering the rehydration solution intake thereafter.

[0032] According to some embodiments of the invention, the tapering includes: replacing 80 to 100% of a subject’s water intake with a rehydration solution every second day for a period of up to 7 days.

[0033] According to some embodiments of the invention, the tapering includes: replacing 80 to 100% of a subject’s water intake with a rehydration solution every second day for a period of up to 7 days; and thereafter replacing 80 to 100% of a subject’s water intake with a rehydration solution every third day for a period of up to 9 days.

[0034] According to an aspect of some embodiments of the invention, there is provided a kit for use in the treatment and prevention of a neurological disorder including: rehydration salts for producing a rehydration solution; directions for producing the rehydration solution; and instructions for use of the rehydration solution in the treatment and prevention of the neurological disorder. According to some embodiments of the invention, the salts and the glucose are packaged to be dissolved in about 1 liter of water.

[0035] According to some embodiments of the invention, the kit includes: materials and instructions for producing a solution having between 45 to 90 mmol / 1 Sodium; between 20 to 40 mmol / 1 Potassium; and between 20 to 40 g / 1 Glucose.

[0036] According to some embodiments of the invention, the kit further includes magnesium.

[0037] 29. The kit 29b, wherein the magnesium for producing a concentration of between 25 to 200 mg / 1 magnesium.

[0038] According to some embodiments of the invention, the kit further includes: calcium.

[0039] According to some embodiments of the invention, the calcium is for producing a concentration of between 25 to 600 mg / 1 magnesium.

[0040] BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings make apparent to those skilled in the art how embodiments of the invention may be practiced.

[0042] Fig. 1 : Flow diagram for a method of use of sodium supplementation, in accordance with an embodiment of the current invention.

[0043] Fig. 2: A schematic illustration of preparation of a rehydration solution, in accordance with some embodiments of the current invention.

[0044] Fig. 3 : Flow diagram for a dosage regime of sodium supplementation, in accordance with an embodiment of the current invention.

[0045] Fig. 4: Chart of average blood sodium level before and after treatment in accordance with the protocol of Example 1.

[0046] DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION The present invention, in some embodiments thereof, relates to use of rehydration salts in the treatment and / or prevention of migraine headaches, and, more particularly, but not exclusively, to increasing sodium levels in a subject in need thereof.

[0047] Overview

[0048] Some embodiments relate to a use of rehydration salts in the treatment and / or prevention of migraine headaches. According to some embodiments, rehydration salts may be used to increase sodium levels in a subject, thereby treating and / or preventing the occurrence of migraines and / or headaches. According to some embodiments, sodium supplementation may facilitate a targeted strategy for migraine and / or headache prevention and / or relief. According to some embodiments, a subject's sodium levels may be elevated pharmacologically by use of the rehydration salts.

[0049] The intricate interplay between estrogen, sodium regulation, and migraines is particularly relevant in the context of endometriosis, a condition associated with aberrant estrogen levels. The hormonal milieu in endometriosis may exacerbate sodium-related mechanisms, further influencing the occurrence and severity of migraines in affected females.

[0050] The precise mechanisms linking sodium, estrogen, endometriosis, and migraines warrant further exploration to unravel the intricate dynamics of this multifaceted relationship.

[0051] According to some embodiments, sodium may be administered in the form of rehydration salts. Optionally, sodium may be administered orally, e.g., as capsules, tablets, rapidly disintegrating tablets, wafers, lozenges, and / or as a solution, syrup, spray, etc. Advantageously, such an approach may offer novel treatment modalities, enhancing patient compliance, and / or expand the therapeutic options for migraine management.

[0052] According to some embodiments, sodium supplementation may be administered repeatedly throughout the day. According to some embodiments, sodium supplementation may be administered repeatedly over a set time period, e.g., a week, 2 weeks, 3 weeks, a month, 2 months, etc. According to some embodiments, sodium supplementation may not be administered as a single bolus (e.g., orally, and / or intravenously), for example in hydration therapy, rehydration treatment, emergency care, dehydration (e.g., after vomiting, diarrhea, gastroenteritis, heat stroke, etc.), and / or metabolic acidosis.

[0053] According to some embodiments, sodium supplementation may facilitate changes in intracellular and / or extracellular sodium concentrations. According to some embodiments, long term administration of sodium supplements (e.g., repeated administration for a week, 2 weeks, 3 weeks, a month, 2 months, etc.), may provide long term and / or permanent changes, e.g., as the body adjusts to maintain higher sodium concentrations. Optionally, long slow dosage may be necessary to facilitate such physiological changes. Optionally, repeated sodium supplementation may change baseline sodium levels in a subject.

[0054] In some cases, sodium levels decrease with age. Advantageously, according to some embodiments, the sodium supplementation regime may take this into account. According to some embodiments, the amount of sodium administered to a subject may be adjusted in accordance with the age of the subject. Optionally, the amount of sodium administered to a subject may be adjusted in accordance with comorbid conditions, e.g., heart disease, kidney disease, diabetes, nephrotic syndrome, cirrhosis, hypertension, etc. Optionally, the amount of sodium administered to a subject may be adjusted according to the subject's individual needs. Optionally, the amount of supplemental sodium administered to a subject may be titrated.

[0055] According to some embodiments, sodium levels may be monitored at intervals during the treatment regime. According to some embodiments, kidney function may be monitored at intervals during the treatment regime. According to some embodiments, blood pressure may be monitored at intervals during the treatment regime.

[0056] According to some embodiments, the amount of supplemental sodium administered per day may range between about 0.05 g / L to about 0.5 g / L, and / or between about 0.5 g / L to about

[0057] 1.5 g / L, and / or between about 1.5 g / L to about 2.5 g / L, and / or between about 2.5 g / L to about

[0058] 3.5 g / L, and / or between about 3.5 g / L to about 5 g / L.

[0059] According to some embodiments, one or more additional salts and / or nutrients and / or osmotic compounds may be co-administered with the supplemental sodium. According to some embodiments, the co-administered salts and / or nutrients and / or osmotic compounds may be administered in an amount sufficient to preserve the required physiological balance of such compounds in the subject. Non-limiting examples of salts and / or nutrients and / or osmotic compounds which may be co-administered are: carbohydrates, potassium salts, citric acid salts, phosphates, etc. Optionally, the sodium to potassium ratio may be maintained at a ratio of <1.0, which is considered to be optimal for preserving cardiovascular health. According to some embodiments, the sodium supplement may be administered as part of a rehydration solution. For example, the rehydration solution may include: sodium chloride, 3.5 grams; 2. trisodium citrate dihydrate, 2.9 grams; 3. potassium chloride, 1.5 grams; 4. glucose, 20,0 grams dissolved in 1 liter of water. According to some embodiments, the rehydration salts may be administered in solution and / or a kit may contain materials and instructions for producing a solution having between 45 to 90 mmol / 1 Sodium and / or between 15 to 45 mmol / 1 Sodium and / or between 90 to 270 mmol / 1 Sodium.

[0060] According to some embodiments, the rehydration salts may be administered in solution and / or a kit may contain materials and instructions for producing a solution having between 20 to 40 mmol / 1 Potassium and / or 5 to 20 mmol / 1 Potassium and / or 40 to a20 mmol / 1 Potassium

[0061] According to some embodiments, the rehydration salts may be administered in solution and / or a kit may contain materials and instructions for producing a solution having between 20 to 40 g / 1 Glucose.

[0062] According to some embodiments, the rehydration salts may be administered in solution and / or a kit may contain materials and instructions for producing a solution having magnesium. For example, the magnesium may be for a concentration of between 25 to 200 mg / 1 magnesium.

[0063] According to some embodiments, the rehydration salts may be administered in solution and / or a kit may contain materials and instructions for producing a solution having magnesium. For example, the magnesium may be for a concentration of between 25 to 600 mg / 1 magnesium.

[0064] According to some embodiments, the amount of supplemental sodium administered to a subject may be tapered at a set rate over a pre-determined period, e.g., days, weeks, months, etc. According to some embodiments, the effects of sodium supplementation may persist even after treatment with supplemental sodium has been discontinued.

[0065] According to some embodiments, sodium supplementation may be used to treat and / or prevent and / or control neurological disorders such as, headaches, migraine with aura, migraine without aura, chronic migraine, migraine with brainstem aura, vestibular migraine, abdominal migraine, hemiplegic migraine, menstrual migraine, etc.

[0066] According to some embodiments, sodium supplementation may reduce and / or prevent one or more symptoms of migraine, e.g., headache, sensitivity to light, nausea, vomiting, cognitive dysfunction, allodynia, dizziness, etc. According to some embodiments, sodium supplementation may reduce and / or prevent one or more symptoms during one or more phases of a migraine attack, e.g., prodrome phase, aura phase, pain phase, postdrome phase, etc.

[0067] According to some embodiments, sodium supplementation may be administered prior to experiencing a migraine. Optionally, sodium supplementation may be administered when a subject is at risk of experiencing a migraine. Optionally, sodium supplementation may be administered to a subject with one or more of the following risk factors for migraine: a change and / or expected change in estrogen level (e.g. perimenopause, approaching puberty, at the beginning of menstruation, at various points during the menstrual cycle, early stages of pregnancy, postpartum, etc.), increase in stress (e.g., starting a new job, moving, increased work load, sick family member, etc.), certain weather conditions (e.g., high pressure system, low pressure system, humidity, etc.), various medications (e.g., starting to use birth control, vasodilators, etc.).

[0068] According to some embodiments, sodium supplementation may be administered when the subject experiences one or more warning signs of the onset of migraine. Optionally, the warning signs may be sensory changes, e.g., increased sensitivity to light, sound, or smell; visual disturbances, such as, flashing lights or blind spot; tingling sensations in the extremities, dizziness, etc. Optionally, the warning signs may be mood changes, e.g., fatigue, irritability, mood swings, depression, anxiety, cognitive dysfunction, allodynia, etc. Optionally, the warning signs may be gastrointestinal symptoms, e.g., nausea, vomiting, constipation, diarrhea, food cravings, food aversions, etc. Optionally, the warning signs may be other symptoms, such as frequent yawning, neck stiffness, difficulty concentrating, etc.

[0069] According to some embodiments, sodium supplementation may be administered when the subject experiences a migraine.

[0070] In some embodiments, a treatment for and / or prevention for migraines may be administered in relation to menstruation. For example, the regime may be started at an expected time of beginning menstruation and / or 1 to 7 days before the expected time and / or 1 to 7 days after the expected time. Alternatively, or additionally, the dosage may be adjusted according to a subject’s menstrual cycle. Alternatively, or additionally, a dosage may be adjusted in response to abnormal menstrual events, and / or endometriosis, and / or other aberrant estrogen levels, and / or other hormone levels. Alternatively, or additionally, a dosage may be adjusted according to age, and / or onset of menstruation, and / or onset of menopause. In some embodiments, after completing a set of treatment regimens treatment may stop. Optionally treatment may be restarted and / or repeated after a time period (e.g., between 1 to 6 months, and / or between 6 months to 2 years, and / or between 2 to 5 years). Alternatively, or additionally, treatment may be restarted, and / or repeated, in response to changes in sodium levels, and / or hormone levels in the body, and / or in response to another medical conditions and / or medical treatment. Some embodiments relate to a kit for use in the treatment and / or prevention of a neurological disorder. Optionally, the kit may include rehydration salts for dissolving in water. Optionally, the kit may include instructions for use of the rehydration salts in the preparation of a rehydration solution. Optionally, the kit may include instructions for use of the rehydration solution in the treatment and / or prevention of a neurological disorder.

[0071] Specific embodiments

[0072] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0073] Reference is now made to Fig. 1, which is a flow diagram for a method of use of sodium supplementation, in accordance with an embodiment of the current invention. For example, in method 10, a subject's baseline sodium level is determined 12. Optionally, the dosage of sodium supplement is adjusted 14 according to the subject's individual conditions (e.g., according to comorbid conditions, weight, age, BMI, etc.). In some embodiments, the sodium supplement is administered 16 repeatedly (e.g., throughout the day for several days, weeks, or months). The dose of sodium supplement is optionally tapered 18. Optionally, the subject's baseline sodium level is determined after the cessation of sodium supplement administration. Optionally, the subject's health may be monitored during treatment.

[0074] In some embodiments, rehydration solution for treatment and / or prevention of migraines may include 1.35 g / dL of glucose and / or between 1 to 2 g / dL of glucose and / or between 0.5 to 3 g / L of glucose. Alternatively, or additionally, the solution may include between 0 to 0.5 g / L glucose. In some embodiments rehydration solution for treatment and / or prevention of migraines may include 0.9 g / dL of sodium chloride and / or between 0.5 to 2 g / dL of sodium chloride and / or between 0.2 to 3 g / L of sodium chloride. In some embodiments rehydration solution for treatment and / or prevention of migraines may include 0.3 g / dL of Potassium Chloride and / or between 0.1 to 1 g / dL of Potassium Chloride and / or between 1 to 2 g / L of Potassium Chloride. Alternatively, or additionally, the solution may include between 0 to 0.1 g / L Potassium Chloride. In some embodiments, the dosage of rehydration solution for treatment and / or prevention of migraines includes an initial regime ranging from replacing 80 to 100% of water intake with intake of the rehydration solution for a period ranging between 7 to 21 days and / or between 2 to 7 days and / or between 21 to 60 days. For example, the dosage of rehydration solution during the initial regime may range between 0.5 to 2 L / day and / or between 0.1 to 0.5 L / day and / or between 2 to 4 L / day. For example, the dosage during the first regime may include between 5 to 30 g / day of sugar and / or between 0 to 5 g / day of sugar and / or between 30 to 90 g / day of sugar. For example, the dosage during the first regime may include between 5 to 20 g / day of sodium chloride and / or between 0.1 to 5 g / day of sodium chloride and / or between 20 to 60 g / day of sodium chloride. For example, the dosage during the first regime may include between 1 to 10 g / day of Potassium Chloride and / or between 0 to 1 g / day of Potassium Chloride and / or between 10 to 30 g / day of Potassium Chloride.

[0075] In some embodiments, the dosage may be reduced in a second regime after the first regime. Optionally, the second regime includes replacing the water intake with intake of the rehydration solution every second day. Optionally, the dosage of rehydration solution for treatment and / or prevention of migraines includes a second regime ranging from replacing 80 to 100% of water intake with intake of the rehydration solution every second day for a period ranging between 7 to 21 days and / or between 2 to 7 days and / or between 21 to 60 days. For example, the second regime may include a dose ranging between 1 / 3 to 3 / 4 the dose during the first regime. The length of the second regime may range between 1 / 3 to 1 times the length of the first regime, and / or between 1 to 3 times the length of the first regime, and / or between 1 / 3 to 3 times the length of the first regime.

[0076] In some embodiments, the dosage may be reduced in a third regime after the second regime. Optionally, the third regime includes replacing the water intake with intake of the rehydration solution every third day. Optionally, the dosage of rehydration solution for treatment and / or prevention of migraines includes a third regime ranging from replacing 80 to 100% of water intake with intake of the rehydration solution every third day for a period ranging between 7 to 21 days and / or between 2 to 7 days and / or between 21 to 60 days. For example, the third regime may include a dose ranging between 1 / 3 to 3 / 4 the dose during the second regime. The length of the third regime may range between 1 / 3 to 1 times the length of the second regime, and / or between 1 to 3 times the length of the second regime, and / or between 1 / 3 to 3 times the length of the second regime. In some embodiments, before (e.g., between 1 to 7 days before) a treatment period and / or during treatment and / or in a part of the treatment (first 7 days, middle days and / or last 7 days) and / or after treatment (e.g., indefinitely, for a year after treatment, between a month and a year after treatment, between a week and a month after treatment between a day and a week after treament, for a day after treatment) certain activities and / or consumption of certain substances may be limited 31 and / or avoided completely. For example, diuretics, alcohol, caffeine, excessive sweating, antacids, laxatives, highly salty foods etc. may be reduced or eliminated.

[0077] These embodiments are provided by way of example and are in no means intended to limit the scope of the invention.

[0078] While the invention has been described in its preferred form or embodiment with some degree of particularity, it is understood that this description has been given only by way of example and that numerous changes in the details of construction, fabrication, and use, including the combination and arrangement of parts, may be made without departing from the spirit and scope of the invention.

[0079] Examples

[0080] Example 1: Dosing regime

[0081] Method

[0082] To evaluate the impact of rehydration solution consumption on migraines, a cohort of 487 females, self-reporting consistent migraine occurrences (2-3 episodes per week), underwent a substitution of their regular water intake with rehydration solution for 30 days. During the treatment no sweet drinks were allowed. During the treatment no caffeine, theanine or alcohol were allowed. The frequency of migraines was systematically observed, and sodium concentrations were quantified via blood tests conducted both prior to the initiation of the experiment and one month subsequent to it.

[0083] The rehydration solution 24 was prepared by dissolving 1 measured tablespoon (approximately 25 g) of rehydration salts 20 in 1 liter of water 22 at room temperature and stirring until the rehydration salts were completely dissolved (e.g., Fig. 2).

[0084] For example, in method 30, during a 30 day period, each woman followed the following exemplary regimen (Fig. 3): o During the entire treatment period certain activities and / or consumption of certain substances may be limited 31 and / or avoided completely. For example, diuretics, alcohol, caffeine, excessive sweating, antacids, laxatives, highly salty foods etc. may be reduced or eliminated. o For 14 days: water intake replaced 32 by intake of the rehydration solution - the participant was not allowed to drink other fluids o For the next 7 days: water intake replaced 34 by intake of the rehydration solution every second day (1st day - rehydration solution, next day - water). No fluids other than the prescribed water or rehydration solution were allowed. o For the next 9 days: water intake replaced 36 by intake of the same amount of rehydration solution once every 3 days (1st day - rehydration solution, next 2 days - water). No fluids other than the prescribed water or rehydration solution were allowed.

[0085] Results

[0086] All 487 women followed the experiment protocol and reported absence of migraine episodes. The improvement in migraine condition continued for at least 6 months even after returning to regular water consumption. The improvement of the condition was also backed up with elevation in blood sodium levels from an average of 137 mEq / 1 prior to initiation of the protocol to 141 mEq / 1 after the end of the experiment (see Fig. 4), suggesting that an elevation in sodium consumption was the reason for the improvement.

[0087] GENERAL

[0088] It is expected that during the life of a patent maturing from this application many relevant building technologies, artificial intelligence methodologies, computer user interfaces, image capture devices will be developed and the scope of the terms for design elements, analysis routines, user devices is intended to include all such new technologies a priori.

[0089] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein may be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0090] Implementation of the method and / or system of embodiments of the invention can involve performing or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of embodiments of the method and / or system of the invention, several selected tasks could be implemented by hardware, by software or by firmware or by a combination thereof using an operating system.

[0091] As used herein the term “about” refers to ± 10%

[0092] The term "clean water" means potable water without any additives, such as flavorings, salts, etc.

[0093] The terms "comprises", "comprising", "includes", "including", “having” and their conjugates mean "including but not limited to".

[0094] The term “consisting of’ means “including and limited to”.

[0095] The term "consisting essentially of' means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0096] As used herein, the singular form "a", "an" and "the" include plural references unless the context clearly dictates otherwise.

[0097] As used herein, the terms “plurality” and “multiple” and “multi” are used interchangeably and may relate to one or more, e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 50, 100, 250, 500, etc. and / or any value therebetween.

[0098] Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range. Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging / ranges between” a first indicate number and a second indicate number and “ranging / ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

[0099] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0100] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0101] All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.

Claims

CLAIMSWhat is claimed is:

1. A rehydration solution for use in prevention and treatment of neurological disorders.

2. The rehydration solution for use of claim 1, wherein the neurological disorder is selected from headaches, migraine with aura, migraine without aura, chronic migraine, migraine with brainstem aura, vestibular migraine, abdominal migraine, hemiplegic migraine, and menstrual migraine.

3. The rehydration solution for use of claim 1, wherein the neurological disorder is characterized by a warning sign selected from the group consisting of: headache; sensitivity to light, sound or smell; visual disturbances; tingling sensations in extremities; cognitive dysfunction; fatigue; irritability; mood swings; depression; anxiety; allodynia; dizziness; nausea; vomiting; constipation; diarrhea; food cravings; food aversions; frequent yawning; neck stiffness; and difficulty concentrating.

4. The rehydration solution for use of claim 1, wherein the rehydration solution is administered to a subject having at least one of the following risk factors: a change in estrogen level, an expected change in estrogen level, increase in stress, certain weather conditions, and starting various medications.

5. The rehydration solution for use of claim 1, wherein the rehydration solution comprises sodium chloride.

6. The rehydration solution for use of claim 5, further comprising potassium chloride.

7. The rehydration solution for use of claim 5, further comprising glucose.

8. The rehydration solution for use of claim 5, further comprising trisodium citrate dihydrate.

9. The rehydration solution for use of claim 1, comprising: salts including about 3.5g sodium chloride, about 2.9g trisodium citrate dihydrate about 1.5g potassium chloride, about 20g glucose,wherein the salts and the glucose are dissolved in about 1 liter of water.

10. The rehydration solution for use of claim 1, comprising: between 45 to 90 mmol / 1 Sodium; between 20 to 40 mmol / 1 Potassium; and between 20 to 40 g / 1 Glucose.

11. The rehydration solution of claim 10, further comprising magnesium.

12. The rehydration solution of claim 11, wherein said magnesium is at a concentration of between 25 to 200 mg / 1 magnesium.

13. The rehydration solution of claim 10, further comprising: calcium.

14. The rehydration solution of claim 13, wherein said calcium is at a concentration of between 25 to 600 mg / 1 magnesium.

15. A method for prevention and treatment of neurological disorders, the method comprising: administering to a subject in need thereof multiple doses of a rehydration solution over a predetermined period of time.

16. The method according to claim 15, wherein a dosage of rehydration solution is tapered over time.

17. The method according to claim 15, wherein a dosage of rehydration solution for treatment and / or prevention of migraines includes an initial regime, a second regime after the initial regime, and a third regime after the second regime.

18. The method according to claim 17, wherein the second regime includes a dose ranging between 1 / 3 to 3 / 4 of the dose during the initial regime.

19. The method according to claim 17, wherein the third regime includes a dose ranging between 1 / 3 to 3 / 4 of the dose during the second regime.

20. The method according to claim 17, wherein length of the second regime ranges between 1 / 3 to 3 times the length of the initial regime.

21. The method according to claim 17, wherein length of the third regime ranges between 1 / 3 to 3 times the length of the second regime.

22. The method according to claim 17, wherein the subject is denied sweet drinks except the dehydration formula during the treatment.

23. The method according to claim 17, wherein the subject is denied diuretics except the dehydration formula during the treatment.

24. A method for prevention and treatment of neurological disorders, the method comprising: replacing 80 to 100% of a subject’s water intake with a rehydration solution for a period of up to 14 days, wherein the rehydration solution comprises a sodium supplement; and tapering the rehydration solution intake thereafter.

25. The method of claim 24, wherein the tapering comprises: replacing 80 to 100% of a subject’s water intake with a rehydration solution every second day for a period of up to 7 days.

26. The method of claim 24, wherein the tapering comprises: replacing 80 to 100% of a subject’s water intake with a rehydration solution every second day for a period of up to 7 days; and thereafter replacing 80 to 100% of a subject’s water intake with a rehydration solution every third day for a period of up to 9 days.

27. The method according to claim 24, wherein the subject is denied sweet drinks except the dehydration formula during the treatment.

28. The method according to claim 17, wherein the subject is denied diuretics except the dehydration formula during the treatment.

29. A kit for use in treatment and prevention of a neurological disorder comprising: rehydration salts for producing a rehydration solution; directions for producing the rehydration solution; andinstructions for use of the rehydration solution in the treatment and prevention of the neurological disorder.

30. The kit of claim 29, comprising: about 3.5g sodium chloride, about 2.9g trisodium citrate dihydrate about 1.5g potassium chloride, about 20g glucose, wherein the salts and the glucose are packaged to be dissolved in about 1 liter of water.

31. The kit of claim 29, comprising: materials and instructions for producing a solution having between 45 to 90 mmol / 1 Sodium; between 20 to 40 mmol / 1 Potassium; and between 20 to 40 g / 1 Glucose.

32. The kit of claim 31, further comprising magnesium.

33. The kit of claim 32, wherein said magnesium for producing a concentration of between 25 to 200 mg / 1 magnesium.

34. The kit of claim 31, further comprising: calcium.

35. The kit of claim 34, wherein said calcium is for producing a concentration of between 25 to 600 mg / 1 magnesium.

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