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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02394691 |
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Date of registration:
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11/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Repeated tDCS Sessions on Cognitive Improvement in Patients With Disorders of Consciousness
rtDCS in DOC |
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Scientific title:
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Effect of Daily Left Prefrontal Dorsolateral Transcranial Direct Current Stimulation Sessions on Cognitive Improvement in Patients With Disorders of Consciousness |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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37 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02394691 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- be in an minimally conscious state
- be chronic (more then 3 months post insult)
- stable condition
Exclusion Criteria:
- NMDA receptor inhibitor drugs
- modification of the treatment during the protocol
- illness or infection during the protocol
- pacemaker
- metallic cerebral implant
- prior neurological disorder
- tDCS or other non-invasive brain stimulation treatment less than 3months before the
inclusion in the present study
Age minimum:
16 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Post-comatose Non-communicative Patients
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Disorders of Consciousness
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Severe Brain Injury
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Intervention(s)
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Device: transcranial direct current stimulation
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Primary Outcome(s)
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Usability of the device in daily clinical practice (compliance of the device by the caregivers)
[Time Frame: After the end of the protocol (24 weeks)]
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Change in the CRS-R total score
[Time Frame: after each stimulation sessions (4 weeks) and 8 weeks later]
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Safety of the device (adverse effect)
[Time Frame: Recorded after each stimulations sessions (4 weeks) and 8 weeks later]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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