NCT02465970

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

November 13, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

June 1, 2015

Last Update Submit

January 8, 2019

Conditions

Epilepsy

Keywords

Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

TDCS session

EXPERIMENTAL

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

Device: STARSTIM

TDCS Placebo

PLACEBO COMPARATOR

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

Device: sham TDCS

Interventions

STARSTIMDEVICE

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

Also known as: TDCS TransCranial Direct Current Stimulation
TDCS session
sham TDCSDEVICE
TDCS Placebo

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Focal epilepsy in which epileptogenic zone is documented by paraclinical examinations consistent with clinical data
  • Existence of measurable EEG markers of epilepsy
  • Signed informed consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Neurologie

Rennes, 35000, France

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • BIRABEN Arnaud

    Rennes HU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2015

First Posted

June 9, 2015

Study Start

November 13, 2015

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations

FR(1)