Fronto-parietal tDCS in Severely Brain Injured Patients With Disorders of Consciousness
Condition: Vegetative State; Minimally Conscious State; Disorders of Consciousness
MeSH terms: Consciousness Disorders; Persistent Vegetative State
Study type: Interventional

Summary: 
      Previous studies showed that anodal transcranial direct current stimulation (tDCS)
      transiently improves performance of memory and attention. In severely brain injured patients
      with disorders of consciousness (DOC), a single stimulation over the left dorsolateral
      prefrontal cortex has shown to improve patients' sign of consciousness. Nevertheless, other
      brain areas could be stimulated in order to increase the number of responders. In this study,
      investigators will assess the effects of bilateral fronto-parietal tDCS on Coma Recovery
      Scale-Revised (CRS-R) scores in patients with DOC in a double-blind sham-controlled
      experimental design.
    

Detailed description: 
      Following severe brain damage and coma, some patients may remain in a vegetative state (VS)
      or minimally conscious state (MCS). At present, there are no evidence-based guidelines
      regarding the treatment of patients with disorders of consciousness (DOC). A previous study
      showed that a single stimulation (using transcranial direct current stimulation - tDCS) of
      the left prefrontal cortex induces an behavioral improvement in some patients in DOC.
      Nevertheless, only 43% of patients in MCS responded to the stimulation. Therefore, it is
      needed to find new protocols to increase the number of responders and improve the effect of
      tDCS in patients with DOC.

      In this study, investigators aim to assess the effect of single session anodal (i.e.,
      excitatory) transcranial direct current stimulation (tDCS) over right and left
      fronto-temporal cortices (using 4 anodes and 4 cathodes), on the level of consciousness of
      patients with DOC, in a double blind randomized sham controlled study. The anodes will be
      placed over F3, F3, CP5 and CP6.

      tDCS is a form of safe non-invasive cortical stimulation, modulating cortical excitability
      under the electrodes, via weak polarizing currents. It has been reported that anodal tDCS
      transiently improves working memory and attention by stimulating the left DLPF in healthy
      subjects and patients with stroke, Parkinson's or Alzheimer's disease. By increasing the
      surface of the stimulated area, it is expected to increase the number of responders as
      patients' brain lesion are very heterogeneous and widespread.
    

Intervention name(s): Anodal tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): Patients will receive anodal tDCS during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised) and an EEG. The anodes will be placed over F3, F4, CP5, and CP6 in order to stimulation the fronto-parietal cortex bilaterally.; Identical to anodal tDCS, except that the stimulation will be stopped after 15 seconds.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vegetative state; minimally conscious state; disorder of consciousness; transcranial current direct stimulation; non invasive brain stimulation; neuromodulation