Clinical trial NCT03114397: Long-term Effect of tDCS in Patients With Disorders of Consciousness
Official title: Long-term Effect of 20 Sessions of Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness: a Double Blind Sham Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Consciousness
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: Fondazione Salvatore Maugeri, Italy
name: Université Catholique de Louvain, Belgium
name: Hospitales Nisa, Spain
name: I.R.C.C.S. Fondazione Santa Lucia, Italy
name: Schoen Clinic Bad Aibling, Germany
name: Research Center of Neurology, Russia
name: Therapiezentrum Burgau, Germany
name: pavlov state medical university, Russia
name: Azienda Unita Sanitaria Locale di Piacenza, Italy
First posted: 2017-04-14
Enrollment: 62
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* CNS medication stable for at least a week
* Stable diagnosis (no diagnosis change based on 2 CRS-R performed within 1 week).
* Between 3 and 24 months post injury
* Structural MRI or CT-scan (to evidence focal lesions on the left DLPFC)

Exclusion Criteria:

* Craniotomies encompassing the frontal region (electrodes location)
* VPS under the stimulated area (prefrontal cortex)
* Pacemaker
* Metallic cerebral implant
* Severe medical conditions that might influence clinical diagnosis and EEG activity (e.g., severe hepatic insufficiency or renal failure, or sub-continuous or abundant epileptiform discharges on standard EEG recordings).

Primary outcomes:
measure: Change in the CRS-R total score
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: University of Liege
Study officials:
References:
citation: 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.
citation: 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.