Trial Outcomes & Findings for Brain Stimulation and Rehabilitation for Adults With Chronic, Severe Arm Motor Impairment After Stroke (NCT NCT03538795)

Last Updated: 2020-12-21

Results Overview

Structured interview that assesses use of the more-affected arm in daily life. Scale range is 0 (no use of the more-affected arm) to 5 (use that is as good before stroke). Higher scores are better. Score reported is change from Day 0 to Day 42.

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

Change from Day 0 to Day 42

Results posted on

2020-12-21

Participant Flow

Participants will be recruited from a list of stroke survivors who have contacted our lab but have been excluded from past studies because their motor impairment was too severe. The recruitment period was June 11, 2018 to February 14, 2019.

Participant milestones

Participant milestones
Measure	iTBS&eCIMT Participants will first receive baseline testing followed by a no-treatment control period. Will then be tested again, receive the combination therapy, i.e., iTBS\&eCIMT, and then receive post-treatment testing. Intermittent Theta Burst Stimulation (iTBS) \& Expanded Constraint-Induced Movement Therapy (eCIMT): All will receive eCIMT+iTBS on an outpatient basis for 4 hours/day for 15 consecutive weekdays. eCIMT will include training of the more-affected arm following shaping principles, restraint of the less-affected arm, and the Transfer Package in combination with neurodevelopmental techniques (NDT) techniques to reduce tone so that shaping of movement can be carried out. The Transfer Package is a set of behavioral techniques designed to transfer therapeutic gains from the treatment setting to everyday life. iTBS will be added to prime the areas of the brain that control movement of the more-affected arm so that the responsiveness of that tissue to motor training is enhanced.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brain Stimulation and Rehabilitation for Adults With Chronic, Severe Arm Motor Impairment After Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	iTBS&eCIMT n=3 Participants Participants will first receive baseline testing followed by a no-treatment control period. Participants will then be tested again, receive the combination therapy, i.e., iTBS\&eCIMT, and then receive post-treatment testing. iTBS\&eCIMT: All will receive eCIMT+iTBS on an outpatient basis for 4 hours/day for 15 consecutive weekdays. eCIMT will include training of the more-affected arm following shaping principles, restraint of the less-affected arm, and the Transfer Package in combination with NDT techniques to reduce tone so that shaping of movement can be carried out. The Transfer Package is a set of behavioral techniques designed to transfer therapeutic gains from the treatment setting to everyday life. iTBS will be added to prime the areas of the brain that control movement of the more-affected arm so that the responsiveness of that tissue to motor training is enhanced. Treatment sessions will alternate between 10 minute periods of iTBS (which include time for set-up and transition)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Day 0 to Day 42

Outcome measures

Outcome measures
Measure	iTBS&eCIMT n=3 Participants Participants will first receive baseline testing followed by a no-treatment control period. Participants will then be tested again, receive the combination therapy, i.e., iTBS\&eCIMT, and then receive post-treatment testing. iTBS\&eCIMT: All will receive eCIMT+iTBS on an outpatient basis for 4 hours/day for 15 consecutive weekdays. eCIMT will include training of the more-affected arm following shaping principles, restraint of the less-affected arm, and the Transfer Package in combination with NDT techniques to reduce tone so that shaping of movement can be carried out. The Transfer Package is a set of behavioral techniques designed to transfer therapeutic gains from the treatment setting to everyday life. iTBS will be added to prime the areas of the brain that control movement of the more-affected arm so that the responsiveness of that tissue to motor training is enhanced. Treatment sessions will alternate between 10 minute periods of iTBS and 1-hour periods of eCIMT.
Motor Activity Log (MAL)	1.8 units on a scale, range = 0-5 Standard Deviation 0.6

SECONDARY outcome

Timeframe: Change from Day 0 to Day 42

Population: Study terminated early due to lack of funds. No funds available to score this test for the 3 participants who completed the study. Unable to analyze due to smaller than projected sample size.

Laboratory motor performance test that assesses motor capacity of the more-affected arm. Scale range is 0 to infinite. Higher scores are better.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from Day 0 to Day 42

Population: Study terminated early due to lack of funds. No funds available to score this test for the 3 participants who completed study. Unable to analyze outcome due to smaller than projected sample size.

Structured interview that assesses use of the arms in daily life

Outcome measures

Outcome data not reported

Adverse Events

iTBS&eCIMT

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	iTBS&eCIMT n=3 participants at risk Participants will first receive baseline testing followed by a no-treatment control period. Participants will then be tested again, receive the combination therapy, i.e., iTBS\&eCIMT, and then receive post-treatment testing. iTBS\&eCIMT: All will receive eCIMT+iTBS on an outpatient basis for 4 hours/day for 15 consecutive weekdays. eCIMT will include training of the more-affected arm following shaping principles, restraint of the less-affected arm, and the Transfer Package in combination with NDT techniques to reduce tone so that shaping of movement can be carried out. The Transfer Package is a set of behavioral techniques designed to transfer therapeutic gains from the treatment setting to everyday life. iTBS will be added to prime the areas of the brain that control movement of the more-affected arm so that the responsiveness of that tissue to motor training is enhanced. Treatment sessions will alternate between 10 minute periods of iTBS and 1-hour periods of eCIMT.
Vascular disorders Elevated blood pressure	33.3% 1/3 • Number of events 1 • 42 days Selected, anticipated medical problems in the target population, i.e, stroke, were assessed either as part of the outcome testing or trainers and testers regularly asked about the presence of symptoms of interest.
Nervous system disorders Pain	33.3% 1/3 • Number of events 3 • 42 days Selected, anticipated medical problems in the target population, i.e, stroke, were assessed either as part of the outcome testing or trainers and testers regularly asked about the presence of symptoms of interest.
Psychiatric disorders Depressive symptoms	33.3% 1/3 • Number of events 1 • 42 days Selected, anticipated medical problems in the target population, i.e, stroke, were assessed either as part of the outcome testing or trainers and testers regularly asked about the presence of symptoms of interest.
Metabolism and nutrition disorders Lethargy	33.3% 1/3 • Number of events 1 • 42 days Selected, anticipated medical problems in the target population, i.e, stroke, were assessed either as part of the outcome testing or trainers and testers regularly asked about the presence of symptoms of interest.

Additional Information

Gitendra Uswatte

University of Alabama of Birmingham

Phone: 205-975-5089

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place