Trial Outcomes & Findings for Brain Stimulation and Robotics in Chronic Stroke Motor Recovery (NCT NCT03562663)

NCT ID: NCT03562663

Last Updated: 2021-01-20

Results Overview

Upper limb fugl Meyer score is a measure of upper extremity motor weakness on a 66-point scale. Fugl Meyer score range: 0-66. Higher scores indicate better outcome. Units: Units on a scale.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 82 participants
• Primary outcome timeframe: Baseline and after the 12-week intervention
• Results posted on: 2021-01-20

Participant Flow

CVA's identified (n=1600) * Excluded on initial screen (n=859) 425 with residential proximity to studying site contacted * Excluded for the following reasons (n=343) Randomized (n=82) Robot Sham (n=41) * Included in the post 6 months analysis (n=35) Robot tDCS (n=41) * Included in the post 6 months analysis (n=34)

Participant milestones

Measure	Active tDCS Participants in this group received 20 minutes of active 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic intervention. Transcranial direct current stimulation: A constant, low current stimulation is provided non-invasively through sponge electrodes positioned over the motor cortex of the affected arm. The stimulation is provided for 20 minutes at an intensity of 2 mA. Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study.	Sham tDCS Participants in this group received 20 minutes of sham 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic training. Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study.
Overall Study STARTED	41	41
Overall Study COMPLETED	34	35
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brain Stimulation and Robotics in Chronic Stroke Motor Recovery

Baseline characteristics by cohort

Measure	Active tDCS n=41 Participants Participants in this group received 20 minutes of active 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic intervention. Transcranial direct current stimulation: A constant, low current stimulation is provided non-invasively through sponge electrodes positioned over the motor cortex of the affected arm. The stimulation is provided for 20 minutes at an intensity of 2 mA. Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study.	Sham tDCS n=41 Participants Participants in this group received 20 minutes of sham 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic training. Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study.	Total n=82 Participants Total of all reporting groups
Age, Continuous	66.0 years n=93 Participants	70.0 years n=4 Participants	68.5 years n=27 Participants
Sex: Female, Male Female	16 Participants n=93 Participants	16 Participants n=4 Participants	32 Participants n=27 Participants
Sex: Female, Male Male	25 Participants n=93 Participants	25 Participants n=4 Participants	50 Participants n=27 Participants
Time since stroke	1201 days n=93 Participants	654 days n=4 Participants	852.5 days n=27 Participants
Fugl-Meyer score	22.0 units on a scale n=93 Participants	21.5 units on a scale n=4 Participants	21.8 units on a scale n=27 Participants

PRIMARY outcome

Timeframe: Baseline and after the 12-week intervention

Population: Of the 41 enrolled for active tDCS, 1 was lost due to unrelated illness and could not complete assessment after the 12-week intervention. Only 40 participant's data were included in the analysis. Of the 41 enrolled for Sham tDCS, 1 person was excluded due to Botox treatment, 2 people were excluded due to unrelated illness and 1 other person was excluded due to related illness. Only 37 participant's data were included in the analysis.

Upper limb fugl Meyer score is a measure of upper extremity motor weakness on a 66-point scale.

Fugl Meyer score range: 0-66. Higher scores indicate better outcome. Units: Units on a scale.

Outcome measures

Measure	Active tDCS n=40 Participants Participants in this group received 20 minutes of active 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic intervention. Transcranial direct current stimulation: A constant, low current stimulation is provided non-invasively through sponge electrodes positioned over the motor cortex of the affected arm. The stimulation is provided for 20 minutes at an intensity of 2 mA. Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study.	Sham tDCS n=37 Participants Participants in this group received 20 minutes of sham 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic training. Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study.
Change From Baseline in Upper Limb Fugl Meyer Score	7.0 Units on a scale Standard Deviation 4.0	7.7 Units on a scale Standard Deviation 4.9

Adverse Events

Active tDCS

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Sham tDCS

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active tDCS n=41 participants at risk Participants in this group received 20 minutes of active 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic intervention. Transcranial direct current stimulation: A constant, low current stimulation is provided non-invasively through sponge electrodes positioned over the motor cortex of the affected arm. The stimulation is provided for 20 minutes at an intensity of 2 mA. Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study.	Sham tDCS n=41 participants at risk Participants in this group received 20 minutes of sham 2 mA transcranial direct current stimulation over the motor cortex of the affected arm prior to robotic training. Upper extremity robotics: Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study.
Skin and subcutaneous tissue disorders Skin adverse event	4.9% 2/41 • Number of events 2	0.00% 0/41
Nervous system disorders Headache	2.4% 1/41 • Number of events 1	2.4% 1/41 • Number of events 1
Nervous system disorders Sleepiness	2.4% 1/41 • Number of events 1	2.4% 1/41 • Number of events 1
Nervous system disorders Trouble concentrating	4.9% 2/41 • Number of events 2	0.00% 0/41

Additional Information

Dylan Edwards

Moss Rehabilitation Research Institute

Phone: (215) 663-6411

Email: EdwardDy@einstein.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place