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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00005925 |
This study will examine the safety and effectiveness of infusing a chemical called muscimol into the brain to control seizures in patients with intractable epilepsy (frequent seizures that persist despite therapy). Muscimol, which is similar to a naturally occurring brain chemical called GABA, has been shown to reduce seizures in rats. After the infusion study, patients will undergo a standard surgical procedure for controlling seizures.
Patients 18 years of age or older with intractable epilepsy may be eligible for this study. Before entering protocol 00-N-0158, candidates will be screened under protocol 01-N-0139, Evaluation and Treatment of Patients with Epilepsy, with a medical history, physical and neurologic examination, chest X-ray, electrocardiogram, blood and urine tests, electroencephalographic (EEG) monitoring and magnetic resonance imaging (MRI) of the head.
Patients enrolled in this study will have the following procedures:
Depth catheter/electrode placement into the presumed location of the seizure focus (the part of the brain where the seizures originate) - A small hole is drilled through the skull. A depth electrode with a hole in the center of the tubing is passed through the brain into the structures usually involved in intractable epilepsy. MRI will be done to check electrode placement. Video-EEG monitoring will continue for 5 days for this part of the study.
Patients will be tested for their ability to understand and produce speech, see normally, move their arms and legs, distinguish sharp and dull objects, and put pegs in a pegboard. They will be questioned about headache, weakness, numbness or sleepiness. The electrode will be left in place for muscimol infusion (see #3).
Condition | Intervention | Phase |
---|---|---|
Epilepsy |
Drug: Muscimol |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Trial of Intracerebral Infusion in Patients With Medically Intractable Epilepsy |
Estimated Enrollment: | 20 |
Study Start Date: | June 2000 |
Objectives: The objectives of this study are to test the hypotheses that direct infusion of the brain (convection enhanced delivery) with neurotransmitter receptor agonists is 1) safe and 2) can be used to study the basic pathophysiology of the epileptic focus in human subjects. The approach described may be a new approach for precise localization of a seizure focus. It may also prove to indicate the distribution of suppression (in space) required for elimination of seizure activity in individual patients and, by doing so, may more accurately define the minimum treatment area that is required for success. Finally, the data obtained may support the treatment of patients with medically intractable epilepsy with neurotransmitter-specific agents infused directly into the epileptic focus.
Study Population: The study population will include adult patients with medically intractable epilepsy who are candidates for surgical resection of their epileptic region.
Design: Adult patients who are candidates for standard surgical care for medically intractable epilepsy will undergo standard noninvasive evaluation to identify the location of the seizure focus. After surface EEG confirms the side and approximate location of the seizure focus, a depth electrode with a central lumen will be placed in the seizure focus for the purpose of this research study. The lumen in the depth electrode will be used to deliver vehicle (artificial cerebrospinal fluid) or muscimol, a neurotransmitter (gamma-aminobutyric acid, GABA) receptor agonist that suppresses neuronal activity. During the infusion trials, patients will be monitored by neurologic examination and by video-EEG. Following the trials, the epileptic focus will be resected, which is standard care for medically intractable epilepsy, and the surgical specimen will be examined for any histological changes caused by the infusions.
Outcome Measures: Basic pathophysiology of the epileptic focus will be examined by assessing the effect of the infusion on seizure frequency (the primary end point), EEG recordings, motor function, and visual object naming. Safety will be assessed by neurologic examination and by pathologic examination (gross and microscopic) of the resected surgical specimen (presence or absence of infusion-induced injury).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
To be eligible for entry into the study, candidates must meet all the following criteria:
EXCLUSION CRITERIA:
Candidates will be excluded if they:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 000158, 00-N-0158 |
Study First Received: | June 24, 2000 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00005925 History of Changes |
Health Authority: | United States: Federal Government |
Video-EEG Muscimol Depth Electrode Brain Catheter Pharmacology |
Epilepsy Infusion Magnetic Resonance Imaging Epilepsy |
Excitatory Amino Acids Neurotransmitter Agents Muscimol Epilepsy |
GABA Agonists Central Nervous System Diseases Ibotenic Acid Brain Diseases |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Excitatory Amino Acid Agonists Nervous System Diseases Physiological Effects of Drugs Central Nervous System Diseases Excitatory Amino Acid Agents |
Brain Diseases Pharmacologic Actions Muscimol Epilepsy GABA Agonists GABA Agents Ibotenic Acid |