Clinical Trial: Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Multimodal Image-guided Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Refractory Partial Epilepsy.
Brief Summary: The investigators will treat patients with fully characterized refractory unifocal neocortical epilepsy with a technique that delivers magnetic waves (transcranial magnetic stimulation, TMS) to the region that causes the epilepsy. Active rTMS applied over the epileptogenic focus will reduce seizure frequency compared with sham rTMS.
Detailed Summary:
-
Background and study aims
Epilepsy is a disease that causes repetitive seizures. In 60% of people with epilepsy, these seizures start in a small zone of the brain (focal or partial epilepsy). This zone can be in the depth of the temporal lobe (mesial temporal lobe epilepsy) or in another brain region (neocortical epilepsy). Even with optimal medical care, up to 30% of people with epilepsy continue to have seizures.
The investigators will treat people with neocortical partial epilepsy with a technique that delivers magnetic waves (transcranial magnetic stimulation, TMS) to the region that causes the epilepsy. The investigators have good reasons to believe that there will be fewer seizures during several weeks after treatment.
-
Who can participate?
You have neocortical focal epilepsy. A doctor who specializes in epilepsy made this diagnosis. You had at least one seizure recorded while in an epilepsy monitoring unit. You had an MRI scan of the brain. You can deliver us all the results of the tests you had.
You continue to have more than 4 seizures a month. You tried a least two different schemes of anti-epileptic drugs as prescribed by your doctor and those schemes were well tolerated. Nevertheless this never cured the seizures.
You are older than 16 years. You don't plan to become pregnant during the study. You need to faithfully continue your treatment as prescribed by your doctor and don't change the drugs you take from at least 4 weeks before the study until 8 weeks after the last TMS session. You need to be able
Sponsor: Universitaire Ziekenhuizen Leuven
Current Primary Outcome: 50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment [ Time Frame: week 12 after each intervention ]
Number of participants achieving a 50% or greater reduction in seizure frequency from baseline
Original Primary Outcome: 50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment [ Time Frame: week 12 after each intervention ]
Seizure frequency was recorded in patient diaries and reviewed with the neurologist/epileptologist (outcomes assessor) at visits 12 weeks (+/- 1 week) after each intervention.
Current Secondary Outcome: Percentage of Seizure Reduction After Active rTMS Treatment Compared With Placebo Treatment [ Time Frame: week 12 after each treatment ]
Seizure frequency was recorded in patient diaries and reviewed with the neurologist/epileptologist (outcomes assessor) at visits 12 weeks (+/- 1 week) after each intervention. The average weekly seizure rate was calculated and compared to baseline frequency over all participants.
Original Secondary Outcome: Percentage of Seizure Reduction After Active rTMS Treatment Compared With Placebo Treatment [ Time Frame: week 12 after each treatment ]
Seizure frequency was recorded in patient diaries and reviewed with the neurologist/epileptologist (outcomes assessor) at visits 12 weeks (+/- 1 week) after each intervention.
Information By: Universitaire Ziekenhuizen Leuven
Dates:
Date Received: December 4, 2012
Date Started: November 2012
Date Completion:
Last Updated: March 23, 2016
Last Verified: January 2015
