Clinical trial NCT02465970: Effects of Transcranial Direct Current Stimulation (TDCS) in Drug-resistant Partial Epilepsy
Official title: BRAINSTIM : Effects of Transcranial Direct Current Stimulation (TDCS) in Drug-resistant Partial Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Keywords: Transcranial Direct Current Stimulation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 5
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 24 hours
Secondary outcomes:
measure: Clinical : - Significant reduction of the frequency of occurrence of seizures within 24 hours, 48 hours, and 7 days following a session of TDCS.
timeFrame: 24 hours until 7 days
measure: Clinical : - Reduction in the duration of seizures
timeFrame: 6 months
measure: Electrophysiological : Decrease of epileptic EEG paroxysms at 8 and 24 hours after a TDCS session
timeFrame: 8-24 hours
measure: - Clinical : If appropriate, reduction of the frequency of occurrence of secondary generalized seizures.
timeFrame: 6 months
measure: -Clinical : Improvement in the quality of life within 7 days following a TDCS session
timeFrame: 7 days
measure: Electrophysiological : - Decrease of epileptic EEG paroxysms immediately following a TDCS session.
timeFrame: up to 1 min
Other outcomes:
Locations:
city: Rennes
country: France
facility: Service de Neurologie
Study officials:
affiliation: Rennes HU
name: BIRABEN Arnaud
role: PRINCIPAL_INVESTIGATOR
References: