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

Epilepsy Clinical Trial

— BRAINSTIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465970
• Other study ID #: 35RC14_9808
• Status: Completed
• Phase: Phase 2
• Start date: November 13, 2015
• Est. completion date: December 2018

Study information

• Verified date: January 2019
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy

Intervention

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
• sham TDCS

Locations

Country	Name	City	State
France	Service de Neurologie	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Clinical : - Reduction in the duration of seizures		6 months
Secondary	Electrophysiological : Decrease of epileptic EEG paroxysms at 8 and 24 hours after a TDCS session		8-24 hours
Secondary	- Clinical : If appropriate, reduction of the frequency of occurrence of secondary generalized seizures.		6 months
Secondary	-Clinical : Improvement in the quality of life within 7 days following a TDCS session		7 days
Secondary	Electrophysiological : - Decrease of epileptic EEG paroxysms immediately following a TDCS session.		up to 1 min