Method of treating depression, mood disorders and anxiety disorders using neuromodulation

a neuromodulation and depression technology, applied in the field of nerve tissue stimulation for treating depression, anxiety disorders and mood disorders, can solve the problems of chronically disabled, treatment-resistant depression has almost no alternative, major depression remains treatment refractory, etc., and achieves the effect of increasing the level of excitatory neurotransmitter

Inactive Publication Date: 2005-02-10
ADVANCED NEUROMODULATION SYST INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0020] Still further, another therapeutic system comprises a device that is surgically implanted into the subject such that the device is in communication with a predetermined site, for example a subcallosal area. An exemplary device includes a microstimulator (i.e., Bion™ manufactured by Advanced Bionics Corporation) in which the device contains a generating portion and at least one electrode in a single unit. In further embodiments, a lead assembly is associated with at least one electrode of the microstimulator such that the lead can stimulate the predetermined site not in direct contact with the microstimulator.

Problems solved by technology

Those who suffer from treatment-resistant depression have almost no alternatives.
However, despite the aforesaid available treatments, there are patients with major depression that remain treatment refractory and chronically disabled.

Method used

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  • Method of treating depression, mood disorders and anxiety disorders using neuromodulation
  • Method of treating depression, mood disorders and anxiety disorders using neuromodulation
  • Method of treating depression, mood disorders and anxiety disorders using neuromodulation

Examples

Experimental program
Comparison scheme
Effect test

example 1

Patient Selection

[0096] Five patients were selected for electrical stimulation of the brain. Patients were selected based upon various demographics, family history of depression (FHx), age of onset, episodes of depression per year, the medications, other therapies, and the Hamilton rating score, as shown in Table 1. (Note “Dur yr” means duration in years).

[0097] As is known in the art, a score above 7 on the Hamilton 17 scale (“H17”) is an indication of depression. A 50% change in the H17 scale score of from the initial baseline score is considered a clinical response, while a score of less than 7 is considered clinical remission.

TABLE 1Patient DemographicAgeDurEpiPTSexAgeFHxonsetYrYrMedsECTCBTIPTH17dxAF48Y18202.51,2,4NNY29UPBF45Y212461,2,3,5YYY27UPCM37Y2017101,2YYY26UPDM48Y361251,2,5YYY24UPEM59N451531,2,3YNY20BPIIMean472818525

Meds: 1 = SSRI,

2 = bupropion,

3 = atypical antipsychotics,

4 = stimulates,

5 = other (benzo, and anticonvulsants).

example 2

Surgical Procedure

[0098] Under local anesthesia, a stereotactic frame was first placed on the patient's head, followed by acquisition of an MRI (Magnetic Resonance Imaging) scan to localize the target region. Patients were then taken to the operating room where, under local anesthesia, two burr holes were placed behind the hairline. Stereotactic coordinates were derived from the pre-op MRI. The coordinates of this target derived from the Schaltenbrand and Wahren Atlas plate 3 (FIG. 3) were 6-7 mm from the midline (range 2-14 mm), 29 mm anterior to the mid-commissural point range 20-40) and 5mm (range 0-10 mm) below the intra-commissural line.

[0099] Once the target sites were identified, two multi contact electrodes were delivered, one in each hemisphere. The electrodes were connected to a stimulating pulse generator.

[0100] With the patient's participation, each electrode contact was stimulated and acute changes in behavior was assessed using self report and mood rating scales, su...

example 3

Outpatient Programming and Clinical Follow-Up

[0102] Patients returned for generator device programming. There were several parameters that were tested, namely, which electrode contact was to be stimulated, the polarity of stimulation, the frequency and pulse width of stimulation, etc.

[0103] The electrode programming was done on an outpatient basis and involved a series of trials over the course of a week. Electrode contacts that produced acute behavioral changes or fMRI signal changes in the subgenual cingulate area (Brodmann area 25) were tried first. Once basic parameters were set, adjustments were made periodically until a stable program was established.

[0104] Once final stimulation parameters were established, psychiatric symptoms were monitored on a monthly basis. Clinical ratings were quantified using Beck, Hamilton, CGI, and Quality of Life Scales and Serial Neuropsychological Testing. Serial Neuropsychological Testing and PET studies were performed at 8 weeks and 6 months...

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Abstract

The present invention involves a method and a system for using electrical stimulation and / or chemical stimulation to treat depression. More particularly, the method comprises surgically implanting an electrical stimulation lead and / or catheter that is in communication with a predetermined site which is coupled to a signal generator and / or infusion pump that release either an electrical signal and / or a pharmaceutical resulting in stimulation of the predetermined site thereby treating the mood and / or anxiety.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Application Nos. 60 / 511,268 filed Oct. 15, 2003 and 60 / 550,164 filed Mar. 4, 2004 and Canadian Application No. 2,432,810 filed Jun. 19, 2003, each of which is incorporated herein by reference in its entirety.TECHNICAL FIELD [0002] This invention relates to nervous tissue stimulation for treating depression, anxiety disorders and mood disorders, and more particularly to modulating nervous tissue at a predetermined stimulation site in brain tissue. BACKGROUND OF THE INVENTION [0003] Recent estimates indicate that more than 19 million Americans over the age of 18 years experience a depressive illness each year. The American Psychiatric Association recognizes several types of clinical depression, including Mild Depression (Dysthymia), Major Depression, and Bipolar Disorder (Manic-Depression). Major Depression is defined by a constellation of chronic symptoms that include sleep problems, a...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61M5/142A61N1/10A61N1/36
CPCA61M5/14276A61N1/36185A61B5/4848A61N1/36096A61P25/00A61P25/24A61N1/0534
Inventor LOZANO, ANDRES M.MAYBERG, HELEN S.
Owner ADVANCED NEUROMODULATION SYST INC
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