Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS)
Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS)
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.
1. 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.

 2. 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 to keep a diary of your seizures.

 3. What does the study involve?

 You will need to come to the hospital every weekday during two consecutive weeks, every
 three months during nine months for the TMS-treatment. So you will have three treatment
 sessions. You will have a brain scan (FDG-PET) before the first treatment and after each
 session.

 The magnetic pulses will be delivered differently during each of the three treatment
 sessions: once on a rather small area of the brain, once on a larger brain area and once
 using a dummy coil, i.e. you will have two active treatment sessions and one dummy or
 placebo session. The investigators will not tell in which order they deliver the
 treatments.

 4. What are the possible benefits and risks of participating?

 The investigators have good reasons to believe you will have fewer seizures in the weeks
 following the active treatment.
Inclusion Criteria:

 -  fully characterized refractory unifocal neocortical epilepsy (i.e. the epileptogenic
 zone is well defined)

 -  on a stable drug regimen for at least one month,

 -  able to complete a seizure dairy either by the patient or by a significant other

 Exclusion Criteria:

 -  Metal in the head including deep brain stimulators, aneurysmal clips, ventricular
 shunts, cochlear implants, ossicular reconstruction of the middle ear…

 -  pacemaker, implantable cardioverter-defibrillator (ICD)

 -  psychogenic non-epileptic seizures and other non-epileptic spells