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

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
STARSTIM
sham TDCS
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Transcranial Direct Current Stimulation

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Service de Neurologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TDCS session

TDCS Placebo

Arm Description

Intervention : Stimulation is applied during a 60 min session with STARSTIM

Intervention : Stimulation is not applied during a 60 min session with STARSTIM

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 1, 2015
Last Updated
January 8, 2019
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02465970
Brief Title
Effects of Transcranial Direct Current Stimulation (TDCS) in Drug-resistant Partial Epilepsy
Acronym
BRAINSTIM
Official Title
BRAINSTIM : Effects of Transcranial Direct Current Stimulation (TDCS) in Drug-resistant Partial Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 13, 2015 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TDCS session
Arm Type
Experimental
Arm Description
Intervention : Stimulation is applied during a 60 min session with STARSTIM
Arm Title
TDCS Placebo
Arm Type
Placebo Comparator
Arm Description
Intervention : Stimulation is not applied during a 60 min session with STARSTIM
Intervention Type
Device
Intervention Name(s)
STARSTIM
Other Intervention Name(s)
TDCS TransCranial Direct Current Stimulation
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
sham TDCS
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Clinical : - Reduction in the duration of seizures
Time Frame
6 months
Title
Electrophysiological : Decrease of epileptic EEG paroxysms at 8 and 24 hours after a TDCS session
Time Frame
8-24 hours
Title
- Clinical : If appropriate, reduction of the frequency of occurrence of secondary generalized seizures.
Time Frame
6 months
Title
-Clinical : Improvement in the quality of life within 7 days following a TDCS session
Time Frame
7 days
Title
Electrophysiological : - Decrease of epileptic EEG paroxysms immediately following a TDCS session.
Time Frame
up to 1 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BIRABEN Arnaud
Organizational Affiliation
Rennes HU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Neurologie
City
Rennes
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

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

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