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

Rennes University Hospital5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Epilepsy

Interventions

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 24 hours

Secondary Outcomes

Clinical : - Significant reduction of the frequency of occurrence of seizures within 24 hours, 48 hours, and 7 days following a session of TDCS.

Time frame: 24 hours until 7 days

Clinical : - Reduction in the duration of seizures

Time frame: 6 months

Electrophysiological : Decrease of epileptic EEG paroxysms at 8 and 24 hours after a TDCS session

Time frame: 8-24 hours

- Clinical : If appropriate, reduction of the frequency of occurrence of secondary generalized seizures.

Time frame: 6 months

-Clinical : Improvement in the quality of life within 7 days following a TDCS session

Time frame: 7 days

Electrophysiological : - Decrease of epileptic EEG paroxysms immediately following a TDCS session.

Time frame: up to 1 min