Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00006191 · ClinicalTrials.gov registry record
Effect of Levetiracetam on Brain Excitability
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 14
- Enrollment target
NCT00006191 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 14 participants.
The verdict
NCT00006191 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 14 participants
- Enrollment target
Study Summary
This study will examine the effect of the newly developed anti-epileptic drug, levetiracetam, on excitability of the cortex (surface layer) of the brain. Levetiracetam works differently from other anti-seizure drugs, but its mechanism is not well understood. This study may provide insight into a new protection mechanism against seizures as well as the effect of the drug on cortical excitability. Healthy normal volunteers 18 years of age and older may be eligible for this study. Candidates will have a medical history taken and undergo physical and neurological examinations. Participants will undergo two different procedures in four separate sessions. One procedure (cortical excitability) involves taking either levetiracetam or placebo (a look-alike inactive substance) and having transcranial magnetic stimulation (TMS). The other procedure (pinch-training related changes) involves taking levetiracetam or placebo, doing a motor exercise called pinch training, and having transcranial magnetic stimulation. For TMS, a very brief electrical current is passed through an insulated coil wire placed on the scalp. The magnetic pulse travels through the scalp and skull, causing small electrical currents in the cortex that may cause muscle, hand, or arm twitching or it may affect movements or reflexes. During the study, subjects may be asked to make movements, do simple tasks or tense muscles. Electrical activity of the muscles will be recorded using electrodes taped to the skin over the muscle. For the pinch training, the subject makes a brief, brisk pinch after each beat of a metronome every two seconds and then completely relaxes the hand until the next beat. Subjects will be tested on four different days at least 72 hours apart. Each session will last about 3 to 4 hours. Approximate schedule for cortical excitability testing: TMS (study 1) Take levetiracetam or placebo TMS (study 2) \< 60 minutes after drug or placebo TMS (study 3) \< 120 minutes after drug or placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2000-08 |
| Est. Completion | 2001-06 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006191
The ClinicalTrials.gov registry entry for NCT00006191 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 14 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 0 interventions.
NCT00006191 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00006191 about?
NCT00006191 is a clinical study titled "Effect of Levetiracetam on Brain Excitability". This study will examine the effect of the newly developed anti-epileptic drug, levetiracetam, on excitability of the cortex (surface layer) of the brain. Levetiracetam works differently from other anti-seizure drugs, but its mechanism is not well understood. This study may provide insight into a new...
What is the current status of trial NCT00006191?
This trial is currently completed. The enrollment target is 14 participants. The study started on 2000-08. Estimated completion is 2001-06.
Who is sponsoring clinical trial NCT00006191?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.