Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006191
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-08-29
Brief Title:
Effect of Levetiracetam on Brain Excitability
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of Levetiracetam on Cortical Excitability in Humans
Status:
COMPLETED
Status Verified Date:
2000-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-N-0207 | None | None | None |