N/A
Completed N=11
Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS)
Epilepsies, Partial
Source: ClinicalTrials.gov NCT01745952 ↗
Enrolled (actual)
11
Serious AEs
10.7%
Results posted
Apr 2016
Primary outcomePrimary: 50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment — 0; 0; 0; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Seizure Frequency After Active rTMS Treatment Compared With Placebo Treatment |
25.7; 23.5; 28.6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01745952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.