Clinical trial NCT02626403: Fronto-parietal tDCS in Severely Brain Injured Patients With Disorders of Consciousness
Official title: Effect of Fronto-parietal Transcranial Direct Stimulation on the Level of Consciousness in Patients With Disorders of Consciousness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vegetative State
Minimally Conscious State
Disorders of Consciousness
Keywords: vegetative state
minimally conscious state
disorder of consciousness
transcranial current direct stimulation
non invasive brain stimulation
neuromodulation
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 46
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* post comatose patients
* patients in minimally conscious state
* patients with stable condition
* patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)

Exclusion Criteria:

* premorbid neurology antecedent
* patients in coma
* patients \< 28 days after the acute brain injury
* patients with a metallic cerebral implant
* cranioplasty
* shunt

Primary outcomes:
measure: Change in the CRS-R total score
timeFrame: Baseline and directly after the tDCS (20 minutes)
Secondary outcomes:
measure: Change in EEG
timeFrame: Baseline and directly after the tDCS (20 minutes)
measure: Change in CRS-R subscores
timeFrame: Baseline and directly after the tDCS (20 minutes)
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: University of Liege
Study officials:
References:
citation: Thibaut A, Bruno MA, Ledoux D, Demertzi A, Laureys S. tDCS in patients with disorders of consciousness: sham-controlled randomized double-blind study. Neurology. 2014 Apr 1;82(13):1112-8. doi: 10.1212/WNL.0000000000000260. Epub 2014 Feb 26.