Trial Outcomes & Findings for Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness (NCT NCT01673126)

Results Overview

At the group level, assess the modification of CRS-R total scores in anodal tDCS as compared to sham stimulation in VS/UWS and MCS populations The Coma Recovery Scale Revised (CRS-R) is a behavioral scale performed at the patient's bedside. It consists of 23 hierarchically arranged items that comprise 6 subscales addressing auditory, visual, motor, verbal, communication, and arousal functions. Scoring is based on the presence or absence of specific behavioral responses to sensory stimuli administered in a standardized manner. Maximum scores of each subscale are summed to obtain the total score (from 0 to 23). The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

55 participants

Primary outcome timeframe

Baseline and directly after the tDCS (20 minutes)

Results posted on

2014-06-09

Participant Flow

Participant milestones

Participant milestones
Measure	Anodal tDCS Anodal tDCS (on DLPF cortex) first, hen 2 days of washout, then sham tDCS.	Sham tDCS Sham tDCS during first, then 2 days of washout, then anodal tDCS.
Overall Study STARTED	36	26
Overall Study COMPLETED	32	23
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Anodal tDCS Anodal tDCS (on DLPF cortex) first, hen 2 days of washout, then sham tDCS.	Sham tDCS Sham tDCS during first, then 2 days of washout, then anodal tDCS.
Overall Study change of diagnosis	4	3

Baseline Characteristics

Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anodal tDCS First n=32 Participants Patients received anodal tDCS during 20 minutes. Then, washout of 2days. Then sham tDCS.	Sham tDCS First n=23 Participants Patients received sham tDCS during 20 minutes. Then, washout of 2days. Then andoal tDCS.	Total n=55 Participants Total of all reporting groups
Age, Customized	46 years STANDARD_DEVIATION 17 • n=5 Participants	40 years STANDARD_DEVIATION 19 • n=7 Participants	43 years STANDARD_DEVIATION 18 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	16 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment Belgium	32 participants n=5 Participants	23 participants n=7 Participants	55 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and directly after the tDCS (20 minutes)

At the group level, assess the modification of CRS-R total scores in anodal tDCS as compared to sham stimulation in VS/UWS and MCS populations The Coma Recovery Scale Revised (CRS-R) is a behavioral scale performed at the patient's bedside. It consists of 23 hierarchically arranged items that comprise 6 subscales addressing auditory, visual, motor, verbal, communication, and arousal functions. Scoring is based on the presence or absence of specific behavioral responses to sensory stimuli administered in a standardized manner. Maximum scores of each subscale are summed to obtain the total score (from 0 to 23). The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors.

Outcome measures

Outcome measures
Measure	Anodal tDCS First n=55 Participants Patients received anodal tDCS first during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised). Then, a washout period (2days). Then sham tDCS during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised).	Sham tDCS First n=55 Participants Patients received sham tDCS first during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised). Then, a washout period (2days). Then anodal tDCS during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised).
Change in CRS-R Total Scores	12.17 units on a scale Standard Deviation 4.32	10.60 units on a scale Standard Deviation 4.19

SECONDARY outcome

Timeframe: participants will be followed for the duration of 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: participants will be followed for the duration of 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: participants will be followed for the duration of 1 year

Outcome measures

Outcome data not reported

Adverse Events

Anodal tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aurore Thibaut and Pr Steven Laureys

Coma Science Group, University of Liège

Phone: 003243662362

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place