Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS)
Condition: Epilepsies, Partial
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Interventional

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 description: 
      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.
    

Intervention name(s): figure-of-eight active rTMS coil; round active rTMS coil; sham rTMS coil (figure-of-eight)
Intervention type(s): Device; Device; Device
Intervention description(s): navigated rTMS over epileptogenic focus using figure-of-eight active rTMS coil; navigated rTMS over epileptogenic focus using round active rTMS coil; commercially available placebo coil that provides slight sensory stimulation and discharge noise without stimulating cortical tissue
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epilepsies, Partial; Transcranial Magnetic Stimulation