Trial Outcomes & Findings for Novel Brain Signal Feedback Paradigm to Enhance Motor Learning After Stroke (NCT NCT02856035)

Last Updated: 2020-05-21

Results Overview

AMAT-F is a measure of 13 complex, coordinated tasks used in everyday living: functional normality of movement during the 13 tasks. Minimum clinically important difference (MCID) is 0.44 change score. AMAT-F : Arm Motor Abilities Test, functional domain. minimum = 0 points. maximum = 5 points. 5 points is normal function.

Recruitment status

COMPLETED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

change score from baseline to post-treatment; approximately 3 months.

Results posted on

2020-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Stroke Group Intervention: Stroke subjects will receive neural feedback plus FES and motor learning intervention that spans 3 phases and up to a total of 60 sessions. Phase I: real-time fMRI neural feedback training; Phase II: rtfNIRS-based neural feedback learning (built upon self-regulation strategies learned in Phase I and also assisted by neurally-triggered, peripherally-directed FES motor practice of wrist and finger extension); Phase III: motor learning minus neural feedback for an additional sessions up to 60 total; Phase IV: follow-up testing at 3 months after-treatment ends
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm/Group n=4 Participants 4 Stroke survivors \> 6 months post stroke and moderately/severely impaired in upper limb coordination and function.
Age, Categorical <=18 years	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=4 Participants
Sex: Female, Male Female	3 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=4 Participants
Race/Ethnicity, Customized African American	1 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian	1 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	1 Participants n=4 Participants
Region of Enrollment United States	4 Participants n=4 Participants
AMAT-F	1.5 points STANDARD_DEVIATION .24 • n=4 Participants

PRIMARY outcome

Timeframe: change score from baseline to post-treatment; approximately 3 months.

Population: severely impaired chronic stroke survivors

Outcome measures

Outcome measures
Measure	Stroke Group n=4 Participants Intervention: Stroke subjects will receive neural feedback plus FES and motor learning intervention that spans 3 phases and up to a total of 60 sessions. Phase I: real-time fMRI neural feedback training; Phase II: rtfNIRS-based neural feedback learning (built upon self-regulation strategies learned in Phase I and also assisted by neurally-triggered, peripherally-directed FES motor practice of wrist and finger extension); Phase III: motor learning minus neural feedback for an additional sessions up to 60 total; Phase IV: follow-up testing at 3 months after-treatment ends
Arm Motor Abilities Test Functional Domain (AMAT - F)	.54 units on a scale Standard Error .10

SECONDARY outcome

Timeframe: from baseline to post-treatment, approximately 3 months

Population: severely impaired chronic stroke survivors

FM: Fugl-Meyer Coordination Scale: arm/hand coordination of isolated joint movement. The minimum clinically important difference (MCID) is 4.25 points. FM: 0 points, no movement; 66 points, normal coordination throughout the upper limb.

Outcome measures

Outcome measures
Measure	Stroke Group n=4 Participants Intervention: Stroke subjects will receive neural feedback plus FES and motor learning intervention that spans 3 phases and up to a total of 60 sessions. Phase I: real-time fMRI neural feedback training; Phase II: rtfNIRS-based neural feedback learning (built upon self-regulation strategies learned in Phase I and also assisted by neurally-triggered, peripherally-directed FES motor practice of wrist and finger extension); Phase III: motor learning minus neural feedback for an additional sessions up to 60 total; Phase IV: follow-up testing at 3 months after-treatment ends
Change Score From Baseline to Post Treatment for the Fugl Meyer Coordination Scale	10.05 units on a scale Standard Error 3.38

Adverse Events

Stroke Group

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

Dr. Janis J Daly

Department of Veterans Affairs, N Fl/S Georgia VA Medical Center

Phone: 216 402 8940

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place