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NCT00048490 · ClinicalTrials.gov registry record · Phase 2
Transcranial Magnetic Stimulation to Treat Epilepsy
A Phase 2 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
NCT00048490 is a Phase 2 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 70 participants.
The verdict
NCT00048490, a Phase 2 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
Study Summary
This study will use transcranial magnetic stimulation, or TMS (described below), to treat epilepsy in certain patients whose seizures persist despite optimum medical treatment. TMS used in this study is intended to lessen the number of seizures a patient has by decreasing excitability of the brain in the region where the seizures originate. Patients between 5 and 65 years of age who have had epilepsy for two or more years and have had at least one seizure a week for at least 6 months may be eligible for this 18-week study. Their seizures must come from a neocortical focus-that is, near the surface of the brain. Candidates will be selected from the NIH Epilepsy clinic and will be screened with an electroencephalogram (EEG), magnetic resonance imaging (MRI) scans, and blood tests. Participants will keep a diary of the seizures they experience over an 8-week period. After the 8 weeks, they will come to the NIH outpatient clinic for 6 consecutive days for the following procedures: * Day 1: A regular clinic visit, plus 6 hours of video-EEG recording (described below) * Days 2 through 5: Video-EEG monitoring and TMS as follows: 8:00 - 11: 00 a.m. 3 hours video-EEG monitoring 11:00 - 12:30 p.m. TMS (includes set-up time; actual stimulation time lasts 30 minutes) 12:30 - 3:00 p.m. Lunch + rest 3:00 - 4:30 p.m. TMS 4:30 - 7:30 p.m. 3 hours video-EEG monitoring (On the fifth day, subjects will have 6 hours of video-EEG monitoring in the afternoon instead of 3 hours.) Participants will be randomly assigned to one of two TMS groups. One group will have TMS delivered in a way that is thought to have a chance of reducing seizures; the other will have sham, or placebo, stimulation. When the TMS sessions are completed, participants will keep a diary of their seizures for another 8 weeks. Transcranial Magnetic Stimulation For TMS, an insulated wire coil is placed on the subject's scalp. A brief electrical current passes through the coil, creating a magnetic pulse that t
Interventions
- DEVICE transcranial magnetic stimulation (TMS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2002-10 |
| Est. Completion | 2004-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00048490
The ClinicalTrials.gov registry entry for NCT00048490 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which transcranial magnetic stimulation (TMS) is the first listed.
NCT00048490 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00048490 about?
NCT00048490 is a clinical study titled "Transcranial Magnetic Stimulation to Treat Epilepsy". This study will use transcranial magnetic stimulation, or TMS (described below), to treat epilepsy in certain patients whose seizures persist despite optimum medical treatment. TMS used in this study is intended to lessen the number of seizures a patient has by decreasing excitability of the brain i...
What is the current status of trial NCT00048490?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2002-10. Estimated completion is 2004-10.
What interventions are being tested in trial NCT00048490?
The interventions under investigation include: transcranial magnetic stimulation (TMS) (DEVICE).
Who is sponsoring clinical trial NCT00048490?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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