N/A N=11 Randomized Triple-blind Treatment

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

Epilepsies, Partial

Bottom Line

View on ClinicalTrials.gov: NCT01745952 ↗

Enrolled (actual)

Serious AEs

10.7%

Results posted

Apr 2016

Primary outcome: Primary: 50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment — 0; 0; 0; 0 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: figure-of-eight active rTMS coil (Device); round active rTMS coil (Device); sham rTMS coil (figure-of-eight) (Device)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: Universitaire Ziekenhuizen KU Leuven
Primary completion: May 2015

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	—

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.

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

View full record on ClinicalTrials.gov →

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.