Trial Outcomes & Findings for Combined Transcranial Direct Current Stimulation and Motor Imagery-based Robotic Arm Training for Stroke Rehabilitation (NCT NCT01897025)

Results Overview

The total FMA score (range, 0-66) on the stroke-impaired upper extremity was used to measure the motor improvements in this study. Higher score indicates better upper limb motor function. FMA were measured at 3 time points: at baseline (wk 0), at completion of intervention (wk 2), and at a 2-week follow-up (wk 4).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

week 0, week 2, week 4

Results posted on

2016-03-10

Participant Flow

42 chronic stroke subjects underwent screening, of whom 23 were excluded due to not meeting the inclusion criteria (n=5), not meeting the BCI performance criteria (n=10), or declining participation (n=8). A total of 19 subjects were recruited and randomly allocated to the real-tDCS group (n=10) or the sham-tDCS group (n=9).

Participant milestones

Participant milestones
Measure	Real-tDCS With MI-BCI 10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system. Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1. After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time. real-tDCS with MI-BCI: As in Arm Description	Sham-tDCS With MI-BCI 10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows: The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception. MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes. real-tDCS with MI-BCI: As in Arm Description
Overall Study STARTED	10	9
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combined Transcranial Direct Current Stimulation and Motor Imagery-based Robotic Arm Training for Stroke Rehabilitation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Real-tDCS With MI-BCI n=10 Participants 10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system. Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1. After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time. real-tDCS with MI-BCI: As in Arm Description	Sham-tDCS With MI-BCI n=9 Participants 10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows: The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception. MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes. real-tDCS with MI-BCI: As in Arm Description	Total n=19 Participants Total of all reporting groups
Age, Continuous	52.1 years STANDARD_DEVIATION 11.7 • n=5 Participants	56.3 years STANDARD_DEVIATION 9.5 • n=7 Participants	54.1 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment Singapore	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: week 0, week 2, week 4

Population: Subjects aged 21 to 70 years who had their first-ever subcortical stroke at least 9 months before recruitment, with moderate to severe impairment of upper extremity function (subscore of the Fugl-Meyer Motor Assessment \[FMMA\], 11-45), were recruited.

The total FMA score (range, 0-66) on the stroke-impaired upper extremity was used to measure the motor improvements in this study. Higher score indicates better upper limb motor function. FMA were measured at 3 time points: at baseline (wk 0), at completion of intervention (wk 2), and at a 2-week follow-up (wk 4).

Outcome measures

Outcome measures
Measure	Real-tDCS With MI-BCI n=10 Participants 10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system. Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1. After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time. real-tDCS with MI-BCI: As in Arm Description	Sham-tDCS With MI-BCI n=9 Participants 10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows: The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception. MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes. real-tDCS with MI-BCI: As in Arm Description
Upper Extremity Component of Fugl-Meyer Assessment Baseline FMA (week 0)	35.3 units on a scale Standard Deviation 7.8	32.6 units on a scale Standard Deviation 8.1
Upper Extremity Component of Fugl-Meyer Assessment FMA improvement at Week 2 relative to Week 0	0.9 units on a scale Standard Deviation 3.0	0.8 units on a scale Standard Deviation 4.0
Upper Extremity Component of Fugl-Meyer Assessment FMA improvement at Week 4 relative to Week 0	5.0 units on a scale Standard Deviation 4.4	5.4 units on a scale Standard Deviation 5.7

SECONDARY outcome

Timeframe: pre- and post-training, 4 weeks post-training

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

Dr Effie Chew

National University Hospital

Phone: 65-67726198

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place