Fronto-parietal tDCS in Severely Brain Injured Patients With Disorders of Consciousness
NCT ID: NCT02626403
Last Updated: 2019-01-30
Study Results
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Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2015-01-31
2017-09-30
Brief Summary
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Detailed Description
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In this study, investigators aim to assess the effect of single session anodal (i.e., excitatory) transcranial direct current stimulation (tDCS) over right and left fronto-temporal cortices (using 4 anodes and 4 cathodes), on the level of consciousness of patients with DOC, in a double blind randomized sham controlled study. The anodes will be placed over F3, F3, CP5 and CP6.
tDCS is a form of safe non-invasive cortical stimulation, modulating cortical excitability under the electrodes, via weak polarizing currents. It has been reported that anodal tDCS transiently improves working memory and attention by stimulating the left DLPF in healthy subjects and patients with stroke, Parkinson's or Alzheimer's disease. By increasing the surface of the stimulated area, it is expected to increase the number of responders as patients' brain lesion are very heterogeneous and widespread.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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anodal tDCS
Patients will receive anodal tDCS (bilateral fronto-parietal stimulation) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised) and neurophysiological assessment (8 channels EEG).
Anodal tDCS
Patients will receive anodal tDCS during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised) and an EEG. The anodes will be placed over F3, F4, CP5, and CP6 in order to stimulation the fronto-parietal cortex bilaterally.
sham tDCS
Patients will receive sham tDCS (15 second of stimulation) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised) and neurophysiological assessment (8 channels EEG).
Sham tDCS
Identical to anodal tDCS, except that the stimulation will be stopped after 15 seconds.
Interventions
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Anodal tDCS
Patients will receive anodal tDCS during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised) and an EEG. The anodes will be placed over F3, F4, CP5, and CP6 in order to stimulation the fronto-parietal cortex bilaterally.
Sham tDCS
Identical to anodal tDCS, except that the stimulation will be stopped after 15 seconds.
Eligibility Criteria
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Inclusion Criteria
* 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
* patients in coma
* patients \< 28 days after the acute brain injury
* patients with a metallic cerebral implant
* cranioplasty
* shunt
16 Years
75 Years
ALL
No
Sponsors
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University of Liege
OTHER
Responsible Party
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Aurore Thibaut
PhD
Locations
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University of Liege
Liège, , Belgium
Countries
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References
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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.
Other Identifiers
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2014/280
Identifier Type: -
Identifier Source: org_study_id
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