Methods and Systems for Facilitating Clinical Trials

Abstract

The present invention provides methods and systems for improving clinical trials of experimental therapies. The present invention uses minimally invasive, leadless implantable devices that facilitate long term monitoring of a physiological signal (e.g., neural signals) from a patient population which may provide an indication of the effect of the experimental therapy on the patient population. In preferred embodiments, neural signals are sampled from the patients in the patient population with an externally powered, leadless implanted device and are transmitted to an external device for further processing.

Description

CROSS-REFERENCED TO RELATED APPLICATIONS [0001] The present application claims benefit of U.S. Provisional Patent Application Ser. No. 60 / 805,710, filed Jun. 23, 2006, to Harris et al., entitled “Implantable Ambulatory Brain Monitoring System,” the complete disclosure of which is incorporated herein by reference.BACKGROUND OF THE INVENTION [0002] The present invention relates generally to methods for sampling one or more physiological signals from a patient. More specifically, the present invention relates to long term, ambulatory monitoring of one or more neurological signals from a patient using a minimally invasive methods and systems in a clinical trial. [0003] Epilepsy is a disorder of the brain characterized by chronic, recurring seizures. Seizures are a result of uncontrolled discharges of electrical activity in the brain. A seizure typically manifests itself as sudden, involuntary, disruptive, and often destructive sensory, motor, and cognitive phenomena. Seizures are freque...

AI Technical Summary

Benefits of technology

[0011] The present invention provides methods and systems for monitoring one or more physiological signals from the patient. In preferred embodiments, the present invention provides minimally-invasive systems that provide for the long-term, ambulatory monitoring of patient's brain activity. The systems of the present invention will typically include one or more implantable devices that are capable of sampling and transmitting a signal that is indicative of the patient's brain activity to a data collection device that is external to the patient's body. The ambulatory systems of the present invention provide for substantially continuous sampling of brain wave electrical signals (e.g., electroencephalography or “EEG” and electrocorticogram “ECoG”, which are hereinafter referred to collectively as “EEG”).

[0013] The methods of the present invention typically make use of one or more low power implantable devices for minimally invasively sampling the patient's EEG signal. The implantable devices are in communication with a device that is external to the patient's body. The external device is typically configured to transmit power into the implantable device and to store the EEG signal that is sampled by the implantable device. The implantable device and the external device will be in communication with each other through a wireless communication link. While any number of different wireless communication links may be used, in preferred embodiments the systems of the present invention uses a high-frequency communication link. Such a communication link enables transmission of power into the implantable device and facilitates data transfer to and from the implantable device.

Problems solved by technology

A seizure typically manifests itself as sudden, involuntary, disruptive, and often destructive sensory, motor, and cognitive phenomena.

Seizures are frequently associated with physical harm to the body (e.g., tongue biting, limb breakage, and burns), a complete loss of consciousness, and incontinence.

A single seizure most often does not cause significant morbidity or mortality, but severe or recurring seizures (epilepsy) results in major medical, social, and economic consequences.

Epilepsy is most often diagnosed in children and young adults, making the long-term medical and societal burden severe for this population of patients.

People with uncontrolled epilepsy are often significantly limited in their ability to work in many industries and usually cannot legally drive an automobile.

This continuous seizure activity may lead to permanent brain damage, and can be lethal if untreated.

However, for the remaining 30% of the patients, their first AED will fail to fully control their seizures and they will be prescribed a second AED—often in addition to the first—even if the first AED does not stop or change a pattern or frequency of the patient's seizures.

For those patients with infrequent seizures, the problem is further compounded by the fact that they must remain on the drug for many months before they can discern whether there is any benefit.

As a result, physicians are left to prescribe AEDs to these patients without clear and timely data on the efficacy of the medication.

A major challenge for physicians treating epileptic patients is gaining a clear view of the effect of a medication or incremental medications.

However, it is well recognized that such self-reporting is often of poor quality because patients often do not realize when they have had a seizure, or fail to accurately record seizures.

In addition, patients often have “sub-clinical” seizures where the brain experiences a seizure, but the seizure does not manifest itself clinically, and the patient has no way of making note of such seizures.

The “patient diary” problem similarly plagues companies that are developing new, experimental AEDs or electrical stimulation therapies.

Because such a metric is so unreliable, clinical trials for experimental AEDs and stimulation therapies require very large sample populations, which increase the cost of development of the AEDs and stimulation therapies and increases the time it takes to bring the new AEDs and stimulation therapies to the market.

However, such a patient population is not necessarily reflective of target patient population who will be actually using the experimental therapy when the therapy reaches the market.

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