An interventional study of anodal tDCS and sham tDCS in Vegetative State, Minimally Conscious State and Disorder of Consciousness, sponsored by University of Liege. Completed at 1 site in Belgium. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-07-17.
Sponsored by University of Liege · Not applicable, Interventional, and Treatment
Non-invasive brain stimulations techniques have recently shown promising results in patients with disorders. Notably, transcranial direct current stimulation (tDCS) applied over the left dorsolateral prefrontal cortex has proved to be effective in improving signs of consciousness in about 50% of patients in MCS either after a single stimulation or after repeated sessions. However, brain mechanisms underlying tDCS effects remain poorly understood. Here we aim to assess the effects of prefrontal tDCS on neurophysiological (i.e., electroencephalography - EEG - primary outcome) and behavioral (secondary outcome) measures in severely brain-injured patients with DOC.
Currently, therapeutic options for severely brain-injured patients with disorders of consciousness (DOC), including patients in unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS), are limited and still need to be improved to influence long-term outcomes. Non-invasive brain stimulations (NIBS) techniques have recently shown promising results in DOC. Notably, transcranial direct current stimulation (tDCS) applied over the left dorsolateral prefrontal cortex has proved to be effective in improving signs of consciousness in about 50% of patients in MCS either after a single stimulation or after repeated sessions. However, brain mechanisms underlying tDCS effects remain poorly understood.In the present protocol, the investigators will assess the effects of prefrontal tDCS on neurophysiological (i.e., electroencephalography - EEG - primary outcome) and behavioral (secondary outcome) measures in severely brain-injured patients with DOC in a double-blind sham-controlled design. One anodal and one sham tDCS will be delivered in a randomized order in chronic (>28 days post-onset) severely brain-damaged patients. The stimulation will have an intensity of 2 mA and will last 20 minutes. The anode will be placed on the left dorsolateral prefrontal cortex and the cathode on the right supraorbital region. Ten minutes of high-density EEG will be recorded using a 256-channel saline electrode net (Electrical Geodesics) directly before and after each tDCS session. Behavioral assessments will be performed using the Coma Recovery Scale-Revised before and after each session by an investigator blinded to the treatment allocation.
88 studies on the registry are indexed under Persistent Vegetative State; 20 are open to participants now.
This study's enrollment of 15 is below the median of 30 across 55 interventional studies indexed under Persistent Vegetative State.
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Exclusion Criteria:
Patients will receive anodal tDCS (left dorsolateral prefrontal stimulation) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised) and neurophysiological assessment (256 channels EEG).
Device: anodal tDCS
Patients will receive sham tDCS (15 secondes of stimulation) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised) and neurophysiological assessment (256 channels EEG).
Device: sham tDCS
Patients will receive anodal tDCS during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised) and a high density EEG. The anode will be placed over F3 in order to stimulate the left dorsolateral prefrontal cortex and the cathode over the right supraorbital area.
Identical to anodal tDCS, except that the stimulation will be stopped after 15 seconds.
Change in the CRS-R scores
CRS-R will be performed before and after tDCS (anodal and sham). Comparison of the treatment effect (CRS-R total score after tDCS minus before) between real and sham tDCS
Time frame: Baseline and directly after the tDCS (20 minutes)
Change in EEG
256 channels EEG will be record before and after tDCS to record potential cortical changes induce by the stimulation.
Time frame: Baseline and directly after the tDCS (20 minutes)
Change in the vigilance level
Ocular parameters will be record using glasses before and after tDCS to record potential change of the vigilance level
Time frame: Baseline and directly after the tDCS (20 minutes)
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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