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

Phase 2

Completed

• Conditions: Epilepsy
• Interventions: Device: sham TDCS; Device: STARSTIM

• Registration Number: NCT02465970
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-01
• Study First Submitted QC: 2015-06-08
• Study First Posted: 2015-06-09
• Study Start: 2015-11-13
• Primary Completion: 2018-11
• Study Completion: 2018-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TDCS Placebo	sham TDCS	Intervention : Stimulation is not applied during a 60 min session with STARSTIM
TDCS session	STARSTIM	Intervention : Stimulation is applied during a 60 min session with STARSTIM

Primary Outcome Measures

Name	Time	Method
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.	24 hours

Secondary Outcome Measures

Name	Time	Method
Electrophysiological : Decrease of epileptic EEG paroxysms at 8 and 24 hours after a TDCS session	8-24 hours
Clinical : - Reduction in the duration of seizures	6 months
Clinical : - Significant reduction of the frequency of occurrence of seizures within 24 hours, 48 hours, and 7 days following a session of TDCS.	24 hours until 7 days
Electrophysiological : - Decrease of epileptic EEG paroxysms immediately following a TDCS session.	up to 1 min
- Clinical : If appropriate, reduction of the frequency of occurrence of secondary generalized seizures.	6 months
-Clinical : Improvement in the quality of life within 7 days following a TDCS session	7 days

Trial Locations

Locations (1)

Service de Neurologie; 🇫🇷 Rennes, France