Effects of Transcranial Direct Current Stimulation (TDCS) in Drug-resistant Partial Epilepsy (BRAINSTIM)

Rennes University Hospital

Status and phase

Completed

Phase 2

Conditions

Epilepsy

Treatments

Device: sham TDCS

Device: STARSTIM

Study type

Interventional

Funder types

Other

Identifiers

NCT02465970

35RC14_9808

Details and patient eligibility

About

Drug-resistant partial epilepsy has a heavy impact on quality of life and sometimes on life expectancy itself. Only a minority of patients may benefit from a curative epilepsy surgery. Neurostimulation, which can be an effective add-on treatment, is currently mainly represented by vagus nervus stimulation. Transcranial direct current stimulation, a non -invasive technique already used in other areas of neurology, may be efficient on some partial epilepsies, in particular through the individual configuration of stimulation, made possible by recent technological advances.

Main goal : To study the effect of transcranial electrical stimulation on the frequency of seizures in patients with drug-resistant partial epilepsy.

Hypothesis : Reduction of 50% or more in the frequency of occurrence of seizures within 24 hours following an individually configured TDCS session: responders in real TDCS vs placebo stimulation.

Enrollment

5 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age greater than or equal to 15 years;
Patients with drug-partial resistant epilepsy with the following characteristics:
Disabling epilepsy despite an optimized pharmacological treatment.
An average of one seizure a day or more during the week preceding the inclusion
Focal epilepsy in which epileptogenic zone is documented by paraclinical examinations consistent with clinical data
Existence of measurable EEG markers of epilepsy
Anti-epileptic drug treatment unmodified during the 2 weeks preceding the inclusion no change to treatment planned during the study.
Signed informed consent.

Exclusion criteria

Patients under 15 years;
Patients in which a standard quality EEG recording is not possible
Patients with ictal bradycardia or ictal syncope ;
Patients with heart disease which may result in heart arrhythmia ;
Incapacitated patients (curatorship, guardianship), patients deprived of liberty.
Pregnant or lactating women
Vagus nervus stimulation is not an exclusion criteria