Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048490
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-10-31
Brief Title:
Transcranial Magnetic Stimulation to Treat Epilepsy
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Drug-Refractory Neocortical Epilepsy rTMS Treatment
Status:
COMPLETED
Status Verified Date:
2004-10
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 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
800 - 11 00 am 3 hours video-EEG monitoring
1100 - 1230 pm TMS includes set-up time actual stimulation time lasts 30 minutes
1230 - 300 pm Lunch rest
300 - 430 pm TMS
430 - 730 pm 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 subjects scalp A brief electrical current passes through the coil creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the cortex or outer part of the brain The stimulation may cause muscle hand or arm twitching or may cause twitches or temporary tingling in the forearm head or face muscles During the stimulation electrical activity of muscles is recorded with a computer or other recording device using electrodes attached to the skin with tape Some TMS sessions may be videotaped
Video-EEG Recordings
The EEG recording device is housed in a small pouchlike container that is worn below the shoulder attached to a belt worn around the waist
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
800 - 11 00 am 3 hours video-EEG monitoring
1100 - 1230 pm TMS includes set-up time actual stimulation time lasts 30 minutes
1230 - 300 pm Lunch rest
300 - 430 pm TMS
430 - 730 pm 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 subjects scalp A brief electrical current passes through the coil creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the cortex or outer part of the brain The stimulation may cause muscle hand or arm twitching or may cause twitches or temporary tingling in the forearm head or face muscles During the stimulation electrical activity of muscles is recorded with a computer or other recording device using electrodes attached to the skin with tape Some TMS sessions may be videotaped
Video-EEG Recordings
The EEG recording device is housed in a small pouchlike container that is worn below the shoulder attached to a belt worn around the waist
Detailed Description:
In this study we will use repetitive transcranial magnetic stimulation rTMS at 10 Hz to treat patients with poorly controlled neocortical epilepsy refractory to pharmacological treatments as a continuation of our previous study 10 Hz TMS in 24 patients with refractory partial epilepsy Previously we observed that 10 Hz rTMS reduced seizure frequency during the first 2 weeks after TMS although the difference did not reach statistical significance However the results suggested that patients with neocortical temporal foci would have a better response than those with mesial temporal foci We wish to see whether rTMS leads to a significant reduction in seizure frequency in neocortical epilepsy considering the depth of magnetic field The design will include two parallel groups one receiving active treatment and one sham stimulation directed away from the epileptic focus The patients and the rating physicians will be blinded to the treatment 10 Hz TMS is a rate proven to induce long term depression in animal models and reported to decrease the excitability of both human and animal cerebral cortex Our preliminary controlled study showed a trend for reduced seizure frequency after 10 Hz stimulation The main outcome measure will be a reduction in seizure frequency over two weeks after stimulation
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 |
|---|---|---|---|
| 03-N-0024 | None | None | None |