Hemiparesis, Hemiplegia, Stroke
Conditions
Keywords
stroke, hemiplegia, hemiparesis, arm, upper-extremity, motor impairment, transcranial magnetic stimulation (TMS), brain stimulation, neuroplasticity
Brief summary
This pilot study will examine a combination therapy for adults with chronic, severe motor impairment of an arm after stroke. The intervention will combine brain stimulation with physical rehabilitation of the arm on the side of the body more-affected by stroke.
Detailed description
The overarching goal of this program of research is to develop a therapy that produces meaningful and persistent improvements in function of the more-affected arm in stroke survivors with severe, chronic hemiparesis. No treatment with an established evidence base is available now for this large group, who have barely perceptible voluntary movement of the more-affected fingers and wrist. The lab of E. Taub and G. Uswatte has developed an expanded version of Constraint-Induced Movement therapy (CIMT) for this population that has evidence of efficacy for improving use in daily life of the more-affected arm from a case series and small randomized controlled trial (RCT). The original version of CIMT is a form of physical rehabilitation that has evidence of efficacy from multiple RCTs for improving use in daily life of the more-affected arm in adults with mild to moderate hemiparesis after stroke. CIMT has also been shown to produce neuroplastic changes in both grey and white matter structures. Expanded CIMT (eCIMT) combines CIMT with neurodevelopmental techniques (NDT) for managing tone. Studies from by J. Szaflarski and by others suggest that priming CNS tissue for training by electrically stimulating the brain regions that control the target function with excitatory intermittent theta burst stimulation (iTBS) augments the benefits of neurorehabilitation. This pilot study will evaluate the feasibility of combining eCIMT with brain stimulation by iTBS and, on a preliminary basis, will evaluate whether this combination therapy boosts treatment outcomes relative to eCIMT alone.
Interventions
COMBINATION_PRODUCTiTBS&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) and 1-hour periods of eCIMT.
Sponsors
NIH National Rehabilitation Research Resource to Enhance Clinical Trials
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Case series, with a no-treatment control period before the intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* stroke * \> 12 months after stroke onset * severe hemiparesis of more-affected arm
Exclusion criteria
* substantial use of the more-affected arm in daily life * frailty or insufficient stamina to carry out the requirements of the therapy * other neurological or musculoskeletal problems, including pain, affecting the more-affected arm * severe cognitive deficits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor Activity Log (MAL) | Change from Day 0 to Day 42 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wolf Motor Function Test (WMFT) | Change from Day 0 to Day 42 | Laboratory motor performance test that assesses motor capacity of the more-affected arm. Scale range is 0 to infinite. Higher scores are better. |
| Canadian Occupational Performance Measure (COPM) | Change from Day 0 to Day 42 | Structured interview that assesses use of the arms in daily life |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| iTBS&eCIMT 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) | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | iTBS&eCIMT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 2 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Motor Activity Log (MAL)
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.
Time frame: Change from Day 0 to Day 42
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iTBS&eCIMT | Motor Activity Log (MAL) | 1.8 units on a scale, range = 0-5 | Standard Deviation 0.6 |
Secondary
Canadian Occupational Performance Measure (COPM)
Structured interview that assesses use of the arms in daily life
Time frame: 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.
Secondary
Wolf Motor Function Test (WMFT)
Laboratory motor performance test that assesses motor capacity of the more-affected arm. Scale range is 0 to infinite. Higher scores are better.
Time frame: 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.