REC2Stim as a treatment for refractory epilepsy in the sensorimotor cortex

Recruiting

Conditions: epilepsy
seizures
10039911

Registration Number: NL-OMON56134

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- at least 16 years of age
- potential central lobe epilepsy
- on average 2 or more seizures per day or ongoing EPC
- mentally and physically capable of giving informed consent
- minimally 3 anti-epileptic drugs been admitted without effect on seizure
frequency (refractory epilepsy)

Exclusion Criteria

- coagulopathy, including use of anticoagulant or antiplatelet agents
- known allergy to the materials of the implant
- progressive neurological or systemic disease
- contra-indications to the presence of a chronically implanted device, such as
the need for repeated MRI, or concurrent infections
- any brain lesion that would place the patient at an elevated risk for bleeding
- any progressive brain disease, e.g. Rasmussen*s encephalitis or glioma
- presence of any active implanted metallic device, such as cardiac pace-maker,
vagal nerve or deep brain stimulator, cochlear implants, spinal cord stimulator
or metallic parts from non-medical origin
- presence of aneurysm clips
- SOZ outside eloquent cortex

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Mean and maximum duration of the seizure-free interval, motor performance, and<br /><br>quality of life at the end of the study compared to these parameters prior to<br /><br>implantation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Spectral content in a time window prior and post stimulation, number of<br /><br>interictal epileptiform discharges in a time window prior and post stimulation </p><br>