Clinical trial NCT02394691: Effect of Repeated tDCS Sessions on Cognitive Improvement in Patients With Disorders of Consciousness
Official title: Effect of Daily Left Prefrontal Dorsolateral Transcranial Direct Current Stimulation Sessions on Cognitive Improvement in Patients With Disorders of Consciousness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorders of Consciousness
Severe Brain Injury
Post-comatose Non-communicative Patients
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2015-03-20
Enrollment: 37
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this study, researchers will show to caregivers of patients how to use a tDCS device (this device was designed to be easy to use, with fixed parameters and only one button to press to run the stimulation). They will be asked to apply a stimulation every day, 5 days per week during for 4 weeks, in chronic patients in minimally conscious state (MCS).

2 sessions of 4 weeks of stimulations will be realized, one anodal and one sham in a randomized order. Before and after each session, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done 8 weeks after the end of the sessions to assess the long term effect of tDCS.

Detailed description: A single session of tDCS showed positive effects on patients in MCS (study published in Neurology, 2014). Nevertheless, the effects went down after 1 or 2 hours. In a second study (Protocol ID: 2009/201/B) we have found that 5 days of tDCS increase the lasting of the effects up to one week.

To know if tDCS could be use in clinical daily practice, a new study will evaluate the effects of 20 minutes of tDCS over the left prefrontal dorsolateral cortex for 4 weeks, 5 days per week, in chronic patients in MCS.

2 sessions of 4 weeks of stimulation (total=20 stimulations per session) will be performed, one session will be real (anodal stimulation) and one placebo (sham stimulation).

Firstly, the patient will be seen at the hospital for a behavioral assessment (CRS-R) with one of his/her caregiver. The investigator will explain to the caregiver how to perform the stimulation. In addition, he/she will receive a folder and a video. The caregiver will take an exam to be sure he/she performs the tDCS properly.

Before and after each stimulation session, behavioral improvement will be assessed with the CRS-R by a trained neuropsychologist, at the hospital. A final assessment will be done 8 weeks after the end of the session to assess the long term effect of tDCS.

The compliance will be recorded by the deice to be sure that the caregiver performs the stimulation every day as expected.

Researchers expect to see (a) an improvement of the CRS-R total score at the end of the anodal session and (b) this improvement persists for 8 weeks.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the CRS-R total score
timeFrame: after each stimulation sessions (4 weeks) and 8 weeks later
measure: Safety of the device (adverse effect)
timeFrame: Recorded after each stimulations sessions (4 weeks) and 8 weeks later
measure: Usability of the device in daily clinical practice (compliance of the device by the caregivers)
timeFrame: After the end of the protocol (24 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University Hospital of Liège
Study officials:
References:
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.