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Completed

NCT Number: NCT02465970

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Service de Neurologie

Rennes, 35000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STARSTIM

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

Other names: TDCS TransCranial Direct Current Stimulation

Sham tDCS

Device

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.

    Time frame: 24 hours

Secondary outcomes

  1. 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

  2. Clinical : - Reduction in the duration of seizures

    Time frame: 6 months

  3. Electrophysiological : Decrease of epileptic EEG paroxysms at 8 and 24 hours after a TDCS session

    Time frame: 8-24 hours

  4. - Clinical : If appropriate, reduction of the frequency of occurrence of secondary generalized seizures.

    Time frame: 6 months

  5. -Clinical : Improvement in the quality of life within 7 days following a TDCS session

    Time frame: 7 days

  6. Electrophysiological : - Decrease of epileptic EEG paroxysms immediately following a TDCS session.

    Time frame: up to 1 min

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: BRAINSTIM

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 9, 2015
Registry last updated
Jan 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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