Effect of Repeated tDCS Sessions on Cognitive Improvement in Patients With Disorders of Consciousness
Condition: Disorders of Consciousness; Severe Brain Injury; Post-comatose Non-communicative Patients
MeSH terms: Brain Injuries; Consciousness Disorders
Study type: Interventional

Summary: 
      In this study, researchers will show to caregivers of patients how to use a tDCS device (this
      device was designed to be easy to use, with fixed parameters and only one button to press to
      run the stimulation). They will be asked to apply a stimulation every day, 5 days per week
      during for 4 weeks, in chronic patients in minimally conscious state (MCS).

      2 sessions of 4 weeks of stimulations will be realized, one anodal and one sham in a
      randomized order. Before and after each session, behavioral improvement will be assessed with
      the Coma Recovery Scale Revised (CRS-R). A final assessment will be done 8 weeks after the
      end of the sessions to assess the long term effect of tDCS.
    

Detailed description: 
      A single session of tDCS showed positive effects on patients in MCS (study published in
      Neurology, 2014). Nevertheless, the effects went down after 1 or 2 hours. In a second study
      (Protocol ID: 2009/201/B) we have found that 5 days of tDCS increase the lasting of the
      effects up to one week.

      To know if tDCS could be use in clinical daily practice, a new study will evaluate the
      effects of 20 minutes of tDCS over the left prefrontal dorsolateral cortex for 4 weeks, 5
      days per week, in chronic patients in MCS.

      2 sessions of 4 weeks of stimulation (total=20 stimulations per session) will be performed,
      one session will be real (anodal stimulation) and one placebo (sham stimulation).

      Firstly, the patient will be seen at the hospital for a behavioral assessment (CRS-R) with
      one of his/her caregiver. The investigator will explain to the caregiver how to perform the
      stimulation. In addition, he/she will receive a folder and a video. The caregiver will take
      an exam to be sure he/she performs the tDCS properly.

      Before and after each stimulation session, behavioral improvement will be assessed with the
      CRS-R by a trained neuropsychologist, at the hospital. A final assessment will be done 8
      weeks after the end of the session to assess the long term effect of tDCS.

      The compliance will be recorded by the deice to be sure that the caregiver performs the
      stimulation every day as expected.

      Researchers expect to see (a) an improvement of the CRS-R total score at the end of the
      anodal session and (b) this improvement persists for 8 weeks.
    

Intervention name(s): transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): anodal transcranial direct current stimulation on the left dorsolateral prefrontal cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment