Status:
COMPLETED
Sub-study of the NEURODOC Project : Neurophysiological Evaluation of a Routine Care Open Label tDCS Session
Lead Sponsor:
Groupe Hospitalier Pitie-Salpetriere
Conditions:
Disorder of Consciousness
Traumatic Brain Injury
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of effi...
Detailed Description
Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of effi...
Eligibility Criteria
Inclusion
- Age between 18 and 80 years
- Disorder of consciousness assessed by CRS-R (VS, MCS, exitMCS)
- Patients with stable clinical examination (even in intensive care unit)
- Structural brain injury confirmed by cerebral imaging (MRI or TDM)
Exclusion
- Refractory status epilepticus
- Known preexisting severe neurodegenerative disease (ie: Alzheimer disease, Lewy body dementia, ...)
- MRI contraindication: metallic intra-cranial implants, pacemaker or implantable cardioverter-defibrillator, cranial prosthesis
- Pregnant, parturient or breastfeeding women
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04035655
Start Date
October 1 2015
End Date
September 1 2018
Last Update
July 29 2019
Active Locations (1)
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1
Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75013