Trial record 3 of 12 for:    "Myoclonus epilepsy"

Effect of Levetiracetam on Brain Excitability

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00006191
First received: August 29, 2000
Last updated: March 3, 2008
Last verified: August 2000
  Purpose

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


Condition
Healthy
Myoclonic Epilepsy

Study Type: Observational
Official Title: Effects of Levetiracetam on Cortical Excitability in Humans

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 14
Study Start Date: August 2000
Estimated Study Completion Date: June 2001
Detailed Description:

The purpose of this study is to investigate the effect of newly developed antiepileptic drug, levetiracetam, on cortical excitability in humans. This drug may be useful in patients with myoclonus, and its mode of action is not well understood. We plan to determine if oral administration of levetiracetam in therapeutic dosage alters cortical excitability measured by transcranial magnetic stimulation as well as long-term potentiation measured by pinching practice in humans.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006191

Locations
United States, Maryland
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00006191     History of Changes
Other Study ID Numbers: 000207, 00-N-0207
Study First Received: August 29, 2000
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Antiepileptic Drugs
Motor Cortex
Myoclonus
Healthy Volunteer

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Myoclonic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents

ClinicalTrials.gov processed this record on July 26, 2014