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

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

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 Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Device: STARSTIM; Device: sham TDCS

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • Service de neurologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TDCS session; Intervention : Stimulation is applied during a 60 min session with STARSTIM	Device: STARSTIM; Multifocal transcranial direct current stimulation.; CE-marked device, comprising a cap with 2 to 8 electrodes, connected with a programmable mobile stimulator.; The stimulation is applied during a 60 min session; Other Names: TDCS TransCranial Direct Current Stimulation
Placebo Comparator: TDCS Placebo; Intervention : Stimulation is not applied during a 60 min session with STARSTIM	Device: sham TDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
Clinical : - Reduction in the duration of seizures	6 months
Electrophysiological : Decrease of epileptic EEG paroxysms at 8 and 24 hours after a TDCS session	8-24 hours
- 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
Electrophysiological : - Decrease of epileptic EEG paroxysms immediately following a TDCS session.	up to 1 min

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: BIRABEN Arnaud, Rennes HU

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2015
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: June 1, 2015
• First Submitted That Met QC Criteria: June 8, 2015
• First Posted (Estimate): June 9, 2015

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Transcranial Direct Current Stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial
• Other Study ID Numbers: 35RC14_9808