Transcutaneous Auricular Vagal Nerve Stimulation for Post-coma Patients With Disorders of Consciousness
Consciousness Disorder, Minimally Conscious State, Vegetative State
About this trial
This is an interventional treatment trial for Consciousness Disorder focused on measuring Vagus nerve stimulation, Transcutaneous electrical nerve stimulation, Non-invasive brain stimulation, Neuromodulation, High-density EEG, Unresponsive wakefulness syndrome, Vegetative state, Minimally Conscious state, Consciousness disorder
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old
- State of consciousness: unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) as defined by CRS-R performed during the screening period.
- Cerebral damage of known etiology
- Time since injury between 7 and 90 days
- Intact skin at the ears
- Consent given by the substitute decision maker
Exclusion Criteria:
- Anyone who is deemed medically unsuitable for this study as determined by a physician involved with the study (e.g. severe rythmic heart condition)
- Previous history of neurological disorders
- Documented pregnancy
- Active implant (i.e. pacemaker)
- Profound sedation such as one caused by general anaesthetics (e.g., propofol) or a combination of central acting sedatives (e.g., benzodiazepines, opioids)
Sites / Locations
- Centre Neurologique William Lennox
- Centre Hospitalier Universitaire de LiègeRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Active taVNS
Sham taVNS
Patients will receive 5 days of transcutaneous auricular vagal nerve stimulation (taVNS) bilaterally, at the cymba conchae, the active localization. It will be preceded and followed by a clinical assessment (Coma Recovery Scale- Revised) and a neurophysiological assessment (128/256 channels EEG and electrocardiograph) the first and last day of stimulation.
Patients will receive 5 days of transcutaneous auricular vagal nerve stimulation (taVNS) bilaterally, at the ear lobe, the sham localization. It will be preceded and followed by a clinical assessment (Coma Recovery Scale- Revised) and a neurophysiological assessment (128/256 channels EEG and electrocardiograph) the first and last day of stimulation.