Clinical trial NCT03007784: Two Intensities of Transcranial Direct Current Stimulation to Improve Consciousness in Severely Brain Injured Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Disorder of Consciousness
Minimally Conscious State
Vegetative State
Cognitive Impairment
Keywords: Consciousness
Disorder of consciousness
Minimally conscious state
Vegetative state
Exit-MCS
Transcranial direct current stimulation (tDCS)
CRS-R
EEG
Cognitive ERPs
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: Hôpital Raymond Poincaré
name: Hospices Civils de Lyon
First posted: 2017-01-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 efficacy to increase level of consciousness and functional communication in some minimally conscious state (MCS) patients, and in some vegetative state (VS) patients. However the optimal intensity of electrical current stimulation remains unknown.

This study will test the effects of two intensities of tDCS stimulation (either 0.2mA or 2mA) applied on left dorso-lateral prefrontal cortex on both behavior, - assessed by the Coma Recovery Scale-Revised (CRS-R) scores -, as well as quantified EEG recorded during resting state (using algorithms previously designed and published by the investigators) and event-related potentials (using auditory paradigms we previously published) in severely brain damaged patients with disorders of consciousness (MCS, VS, and conscious but cognitively disabled patients) of various etiologies.

Detailed description: This study will use a cross-over double-blind design with each patient receiving both current intensities in a randomized order during 4 weeks (2 weeks for each tDCS intensity, totalizing a number of 10X2 stimulation sessions of 20 minutes each).

Eligibility criteria: Inclusion Criteria:

* Non communicative patients (including conscious patients but presenting with major fluctuations of vigilance and/or of cognitive abilities)
* Patients with stable clinical examination
* Age between 18 and 80 years
* Brain injury confirmed by cerebral imaging (MRI or TDM)
* Disorder of consciousness diagnosed by CRS-R (VS, MCS, exitMCS)

Exclusion Criteria:

* Status epilepticus
* Severely neurodegenerative illnesses (Alzheimer disease, Lewy Body Dementia)
* Pregnancy
* Patients underage

Primary outcomes:
measure: Change of the Coma Recovery Scale-Revised score according to tDCS current intensity (2mA versus 0.2mA)
timeFrame: Last Day of 0.2mA session (Day 14th or Day 28th) versus Last Day of 2mA session (Day 14th or Day 28th)
measure: Change from baseline of the Coma Recovery Scale-Revised score after 2mA tDCS current intensity
timeFrame: Last Day of 2mA session (Day 14th or Day 28th) versus baseline (Day 1st)
measure: Change from baseline of the Coma Recovery Scale-Revised score after 0.2mA tDCS current intensity
timeFrame: Last Day of 0.2mA session (Day 14th or Day 28th) versus baseline (Day 1st)
Secondary outcomes:
measure: IChange of the ERPS recorded during the "local global" auditory paradigm (Bekinschtein et al., PNAS 2009) after 10 days of 2mA tDCS current intensity and after 10 days of 0.2mA tDCS current intensity
timeFrame: Last Day of 2mA session (Day 14th or Day 28th) versus Last Day of 0.2mA session (Day 14th or Day 28th)
measure: Change from baseline of the ERPS recorded during the "local global" auditory paradigm (Bekinschtein et al., PNAS 2009) after 2mA tDCS current intensity
timeFrame: Last Day of 2mA session (Day 14th or Day 28th) versus baseline (Day 1st)
measure: Change from baseline of the ERPS recorded during the "local global" auditory paradigm (Bekinschtein et al., PNAS 2009) after 0.2mA tDCS current intensity
timeFrame: Last Day of 0.2mA session (Day 14th or Day 28th) versus baseline (Day 1st)
measure: IChange of the multivariate automatic classification of conscious state from EEG (Sitt et al., Brain et al. 2014) after 10 days of 2mA tDCS current intensity and after 10 days of 0.2mA tDCS current intensity
timeFrame: Last Day of 2mA session (Day 14th or Day 28th) versus Last Day of 0.2mA session (Day 14th or Day 28th)
measure: Change from baseline of the multivariate automatic classification of conscious state from EEG (Sitt et al., Brain et al. 2014) after 10 days of 2mA tDCS current intensity
timeFrame: Last Day of 2mA session (Day 14th or Day 28th) versus baseline (Day 1st)
measure: Change from baseline of the multivariate automatic classification of conscious state from EEG (Sitt et al., Brain et al. 2014) after 10 days of 0.2mA tDCS current intensity
timeFrame: Last Day of 0.2mA session (Day 14th or Day 28th) versus baseline (Day 1st)
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpêtrière
Study officials:
affiliation: Paris 6 University ICM Inserm APHP
name: Lionel Naccache, MD PhD
role: STUDY_DIRECTOR
References: