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

NCT02465970 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-01-09

No results posted yet for this study

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.

Conditions

Interventions

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

DEVICE

sham TDCS

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • BIRABEN Arnaud · Rennes HU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-13
Primary Completion
2018-11-30
Completion
2018-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02465970 on ClinicalTrials.gov