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| Name | Class |
|---|---|
| Fondazione Salvatore Maugeri, Italy | UNKNOWN |
| Université Catholique de Louvain | OTHER |
| Hospitales Nisa, Spain | UNKNOWN |
| I.R.C.C.S. Fondazione Santa Lucia, Italy |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anodal stimulation | Active Comparator | Patients will receive anodal tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 20minutes) for a total of 20 sessions. |
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| sham stimulation | Placebo Comparator | Patients will receive sham tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 20minutes) for a total of 20 sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation - active | Device | transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the CRS-R total score | Improvement of the CRS-R total score after the end of the anodal session. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Liege | Liège | 4000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28281845 | Background | Thibaut A, Wannez S, Donneau AF, Chatelle C, Gosseries O, Bruno MA, Laureys S. Controlled clinical trial of repeated prefrontal tDCS in patients with chronic minimally conscious state. Brain Inj. 2017;31(4):466-474. doi: 10.1080/02699052.2016.1274776. Epub 2017 Mar 10. | |
| 24574549 | Background | 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. |
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| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| UNKNOWN |
| Schoen Clinic Bad Aibling, Germany | UNKNOWN |
| Research Center of Neurology, Russia | OTHER_GOV |
| Therapiezentrum Burgau, Germany | UNKNOWN |
| pavlov state medical university, Russia | UNKNOWN |
| Azienda Unita Sanitaria Locale di Piacenza | OTHER |
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| transcranial direct current stimulation - sham | Device | 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. |
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |