Disorder of Consciousness
Conditions
Brief summary
In this multicentric double-blind sham controlled study, the investigators plan to assess the effects of 20 sessions of tDCS on long-term behavioral recovery in patients with disorders of consciousness. Neurophysiological outcomes (EEG) will also be collected. This research will 1) determine whether long-term behavioral recovery can be promoted with tDCS and 2) generate knowledge regarding the impact of tDCS on neurophysiological outcome (i.e., EEG) in severely brain injured patients. The investigators will compare the effects of active and sham tDCS on behavioral assessments and quantitative EEG in patients with severe brain injury and its potential application in rehabilitation.
Interventions
transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes.
transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes. The sham intervention consists of 30 seconds of stimulation at the beginning and the end of the 20minutes of intervention.
Sponsors
Fondazione Salvatore Maugeri, Italy
Université Catholique de Louvain, Belgium
Hospitales Nisa, Spain
I.R.C.C.S. Fondazione Santa Lucia, Italy
Schoen Clinic Bad Aibling, Germany
Research Center of Neurology, Russia
Therapiezentrum Burgau, Germany
pavlov state medical university, Russia
Azienda Unita Sanitaria Locale di Piacenza, Italy
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* CNS medication stable for at least a week * Stable diagnosis (no diagnosis change based on 2 CRS-R performed within 1 week). * Between 3 and 24 months post injury * Structural MRI or CT-scan (to evidence focal lesions on the left DLPFC)
Exclusion criteria
* Craniotomies encompassing the frontal region (electrodes location) * VPS under the stimulated area (prefrontal cortex) * Pacemaker * Metallic cerebral implant * Severe medical conditions that might influence clinical diagnosis and EEG activity (e.g., severe hepatic insufficiency or renal failure, or sub-continuous or abundant epileptiform discharges on standard EEG recordings).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the CRS-R total score | 4 weeks | Improvement of the CRS-R total score after the end of the anodal session. |
Countries
Belgium
Outcome results
None listed