Trial Outcomes & Findings for Use of Transcranial Direct Current Stimulation (tDCS) Coupled With Constraint Induced Movement Therapy in Stroke Patient (NCT NCT01143649)

Results Overview

Jebsen Taylor Hand Function Test: measures hand function in real-life activities, by evaluating the time required to perform 7 different tasks. We used the non-cronstrained hand for the assessments. The sum of the different tasks was used for the analysis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

2 weeks

Results posted on

2020-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	tDCS + CIMT - Stroke Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday). Transcranial Stimulation: Subjects will be stimulated at 1 mA for 40 minutes.	Sham tDCS + CIMT - Stroke Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday). Sham stimulation consists of 30secondes of stimulation at the beginning of the 40minutes treatment.	Healthy Participants: Active tDCS + Motor Training Each stimulation day will include up to six hours of training termed "shaping" in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of tDCS at 1mA.	Healthy Participants: Sham tDCS + Motor Training Each stimulation day will include up to six hours of training termed "shaping" in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of sham tDCS.	Healthy Participants - Active tACS, Then Sham Subjects will receive 20 min of active then sham tACS over the primary motor cortex in a randomized order.	Healthy Participants - Sham tACS, Then Active Subjects will receive 20 min of sham and then tACS over the primary motor cortex in a randomized order.
Overall Study STARTED	7	7	10	10	5	5
Overall Study COMPLETED	7	7	10	10	4	3
Overall Study NOT COMPLETED	0	0	0	0	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Transcranial Direct Current Stimulation (tDCS) Coupled With Constraint Induced Movement Therapy in Stroke Patient

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	tDCS + CIMT - Stroke n=7 Participants Participants received active tDCS over the primary motor cortex (M1). We used the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday). Transcranial Stimulation: Subjects were stimulated at 1 mA for 40 minutes.	Sham tDCS + CIMT - Stroke n=7 Participants Participants received sham tDCS over the primary motor cortex plus CIMT. The same site and parameters of stimulation were employed, but the stimulator was turned off after 30 seconds of stimulation. This ensured that patients could feel the initial itching sensation at the beginning of tDCS.	tDCS Active + CIMT - Healthy n=10 Participants Participants received active (1mA - 40min) of the primary motor cortex (M1) bilaterally combined with unilateral motor training and contralateral hand restraint.	Sham tDCS + CIMT - Healthy n=10 Participants Participants received sham tDCS (1mA - 40min) of the primary motor cortex (M1) bilaterally combined with unilateral motor training and contralateral hand restraint.	tACS Active&Sham - Healthy n=10 Participants active or sham 15Hz-tACS over of the primary motor cortex (M1) bilaterally.	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants	0 Participants n=16 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=99 Participants	6 Participants n=107 Participants	10 Participants n=206 Participants	10 Participants n=157 Participants	10 Participants n=390 Participants	43 Participants n=16 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants	1 Participants n=16 Participants
Age, Continuous	42.5 years STANDARD_DEVIATION 12.8 • n=99 Participants	50.8 years STANDARD_DEVIATION 14.9 • n=107 Participants	20.4 years STANDARD_DEVIATION 1.7 • n=206 Participants	20.4 years STANDARD_DEVIATION 1.7 • n=157 Participants	35.83 years STANDARD_DEVIATION 18.65 • n=390 Participants	35.75 years STANDARD_DEVIATION 11.69 • n=16 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	5 Participants n=107 Participants	7 Participants n=206 Participants	7 Participants n=157 Participants	4 Participants n=390 Participants	27 Participants n=16 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants	3 Participants n=157 Participants	6 Participants n=390 Participants	17 Participants n=16 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: The Jebsen Taylor Hand Function Test was only performed in the stroke study (Experiment 1).

Jebsen Taylor Hand Function Test: measures hand function in real-life activities, by evaluating the time required to perform 7 different tasks. We used the non-cronstrained hand for the assessments. The sum of the different tasks was used for the analysis.

Outcome measures

Outcome measures
Measure	tDCS + CIMT n=7 Participants Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday). Transcranial Stimulation: Subjects will be stimulated at 1 mA for 40 minutes.	Sham tDCS + CIMT n=7 Participants Participants received sham tDCS over the primary motor cortex plus CIMT. The same site and parameters of stimulation were employed, but the stimulator was turned off after 30 seconds of stimulation. This ensured that patients could feel the initial itching sensation at the beginning of tDCS.
Jebsen Taylor Hand Function Test	68 seconds Standard Error 34	80 seconds Standard Error 42

PRIMARY outcome

Timeframe: 1 hour

Population: The cortical excitability measurement (MEP) was performed in healthy participants involved in the tDCS+CIMT study (Experiment 2).

Motor evoked potential (MEP) Using Transcranial Magnetic Stimulation (TMS), MEP were recorded before and after tDCS (both active and sham). The percentage of change in MEP (post versus pre intervention) between the two groups (active and sham) were used for the comparison.

Outcome measures

Outcome measures
Measure	tDCS + CIMT n=20 Participants Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday). Transcranial Stimulation: Subjects will be stimulated at 1 mA for 40 minutes.	Sham tDCS + CIMT n=20 Participants Participants received sham tDCS over the primary motor cortex plus CIMT. The same site and parameters of stimulation were employed, but the stimulator was turned off after 30 seconds of stimulation. This ensured that patients could feel the initial itching sensation at the beginning of tDCS.
Cortical Excitability	19.8 percent change Standard Deviation 21.4	0.8 percent change Standard Deviation 8.3

PRIMARY outcome

Timeframe: 15 minutes

Population: The brain oscillations measurements were only performed in the tACS study (Experiment 3).

Recording took place in a dim-lighted room set up with acoustic and electric isolation. EEG was acquired from 64-channels HydroCel Geodesic Sensor Net (Electrical Geodesic Inc., Eugene, OH) and recorded using Net Station running on a MacIntosh G4 computer. Alpha power were used as the main outcome measure. The difference values (e.g., post minus pre tACS) were used for the analysis. The alpha frequency is a brain oscillation that takes place especially when subjects are in a relaxed state, especially eyes closed. In the motor cortex, a decrease in alpha power has been seen during motor performance. Therefore, it could be speculated that a decrease in power in this study would indicate more engagement in motor cortex during the motor performance.