Patients in Minimally Conscious State After a Severe Brain Injury (e.g., Anoxia, Traumatic Brain Injury, Stroke)
Conditions
Keywords
disorders of consciousness, minimally conscious state, traumatic brain injury, stroke, transcranial direct current stimulation
Brief summary
In this study researchers will apply transcranial direct current stimulation (tDCS) for 5 consecutive days in chronic patients in minimally conscious state (MCS). 2 sessions of 5 days of stimulation will be realized, one anodal and one sham. After each stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done one week after the end of the sessions to assess the long term effect of the tDCS.
Detailed description
Positive effects of tDCS in patients in MCS was showed in a recent study published in Neurology. But the effects went down after 1 or 2 hours. To increase the lasting of the effects, a new study will evaluate the effects of tDCS on the left prefrontal dorsolateral cortex for 5 consecutive days in chronic patients in MCS. 2 sessions of 5 days of stimulation will be realized, one session will be real (anodal stimulation) and one placebo (sham stimulation). After each stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done one week after the end of the sessions to assess the long term effect of the tDCS. Researchers expected to see an improvement of the CRS-r total score at the end of the anodal session and that this improvement persists for a week.
Interventions
DEVICEtranscranial direct current stimulation
anodal transcranial direct current stimulation on the left dorsolateral prefrontal cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No
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 or vegetative state * patients \< 3 months after the acute brain injury * patients with a metallic cerebral implant or a pacemaker (in line with the safety criteria for tDCS in humans)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the CRS-R total score | after each stimulation and one week later for anodal and sham sessions (total: 1 month) | Improvement of the CRS-R total score after the end of the anodal session and one week later but no change for the sham session. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Influence of the time since insult | one month | Influence of the time since insult of the results. We expected that the longer a patient is in MCS, the lower is his/her improvement after the tDCS session. |
Countries
Belgium
Outcome results
None listed