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

NCT ID: NCT02465970

Last Updated: 2019-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-13
• Study Completion Date: 2018-12-31

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.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TDCS session

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

Group Type: EXPERIMENTAL

STARSTIM

Intervention Type: DEVICE

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

TDCS Placebo

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

Group Type: PLACEBO_COMPARATOR

sham TDCS

Intervention Type: DEVICE

Interventions

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

Intervention Type: DEVICE

sham TDCS

Intervention Type: DEVICE

Other Intervention Names

TDCS TransCranial Direct Current Stimulation

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BIRABEN Arnaud

Role: PRINCIPAL_INVESTIGATOR

Rennes HU

Locations

Service de Neurologie

Rennes, , France

Countries

France

Other Identifiers

35RC14_9808

Identifier Type: -

Identifier Source: org_study_id