Brain Infusion of Muscimol to Treat Epilepsy
|ClinicalTrials.gov Identifier: NCT00005925|
Recruitment Status : Terminated
First Posted : June 26, 2000
Last Update Posted : October 6, 2017
|First Submitted Date ICMJE||June 24, 2000|
|First Posted Date ICMJE||June 26, 2000|
|Last Update Posted Date||October 6, 2017|
|Study Start Date ICMJE||June 23, 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00005925 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Brain Infusion of Muscimol to Treat Epilepsy|
|Official Title ICMJE||Trial of Intracerebral Infusion in Patients With Medically Intractable Epilepsy|
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:
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).
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Intervention ICMJE||Drug: Muscimol|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Terminated|
|Actual Enrollment ICMJE
|Original Enrollment ICMJE
|Actual Study Completion Date||December 24, 2014|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
To be eligible for entry into the study, candidates must meet all the following criteria:
Candidates will be excluded if they:
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00005925|
|Other Study ID Numbers ICMJE||000158
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 24, 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP