Effect of Levetiracetam on Brain Excitability

NCT00006191 | Completed

• 2 other identifiers: 00020700-N-0207
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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 Approximate schedule for pinch-training related changes: Take levetiracetam or placebo TMS and pinch power measurement \< 60 minutes after drug or placebo Pinch training for 30 minutes TMS and pinch power measurement Sample schedule: Session 1 \< LTC and cortical excitability testing Session 2 \< Placebo and cortical excitability testing Session 3 \< LTC and pinch-training related changes Session 4 \< Placebo and pinch-training related changes

Conditions

Healthy; Myoclonic Epilepsy

Keywords

Antiepileptic Drugs; Motor Cortex; Myoclonus; Healthy Volunteer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

This study will be done on normal volunteers. Subjects will be adults older than age 18. No development of a serious medical condition. Compliance with protocol evaluations or examinations.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Bialer M, Johannessen SI, Kupferberg HJ, Levy RH, Loiseau P, Perucca E. Progress report on new antiepileptic drugs: a summary of the fourth Eilat conference (EILAT IV). Epilepsy Res. 1999 Mar;34(1):1-41. doi: 10.1016/s0920-1211(98)00108-9.

  PMID: 10194110 BACKGROUND

• Wulfert E, Hanin I, Verloes R. Facilitation of calcium-dependent cholinergic function by ucb L059, a new "second generation" nootropic agent. Psychopharmacol Bull. 1989;25(3):498-502.

  PMID: 2626523 BACKGROUND

• Loscher W, Honack D. Profile of ucb L059, a novel anticonvulsant drug, in models of partial and generalized epilepsy in mice and rats. Eur J Pharmacol. 1993 Mar 2;232(2-3):147-58. doi: 10.1016/0014-2999(93)90768-d.

  PMID: 8467854 BACKGROUND

MeSH Terms

Conditions

Epilepsies, Myoclonic; Myoclonus

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 29, 2000
• First Posted: December 10, 2002
• Study Start: August 1, 2000
• Study Completion: June 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2000-08

Locations

US (1)