Cerebrovascular Accident, Stroke
Conditions
Keywords
motor recovery, chronic, human, sensory, afferent input, motor training
Brief summary
The investigators proposed to evaluate the effectiveness of sustained peripheral nerve stimulation (PNS) to enhance the therapeutic effects of a modified form CIT (mCIT).
Detailed description
Stroke is one the most devastating and prevalent diseases, but efforts to limit the amount of tissue damaged in the acute phase have been disappointing, highlighting the need for effective therapeutic interventions after neurologic damage has occurred. A major goal of the research in stroke rehabilitation is to harness the capacity of the brain to reorganize after neurologic damage has occurred and thus ultimately lead to successful recovery of function. Data from animal and human models have suggested that sensory input plays an important role in motor output, possibly by influencing cortical plasticity. However, in spite of the advances to date, little is known about the extent to which sensory input in the form of peripheral nerve stimulation can be successfully combined to physical training. A new emerging approach called constraint-induced therapy (CIT) is an intensive functional motor training and has produced promising results in the field of stroke rehabilitation. CIT involves restraining the unaffected arm with a sling or glove combined with intense task-oriented therapy of the affected side for six hours daily during 2 weeks. This pilot study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled with functional motor training to improve hand motor function. While the functional motor training follows identical principles of CIT, the length of daily training will be shortened to 4 hours daily and thus the investigators will refer in this proposal as a modified CIT. Preliminary data for this study demonstrated that peripheral nerve stimulation results in increased cortical motor excitability in normal subjects. In addition, learning and use-dependent plasticity can be substantially enhanced by a single session of 2 hours of peripheral nerve stimulation in chronic stroke patients. The goal of this study is to test the hypothesis that stroke patients treated with upper extremity peripheral nerve stimulation preceding CIT (intervention group) will have improved hand motor function compared to a group receiving lower extremity peripheral nerve stimulation and CIT (control group).
Interventions
DEVICEperipheral nerve stimulation
Non-invasive stimulation of median, ulnar and radial nerves
Sponsors
University of Kentucky
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic stroke patients * Single stroke * Chronic (more than 12 months after from stroke) * At least 21 years old, but there is no upper age range for this project. * Participants must be able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.
Exclusion criteria
* History of carpal tunnel syndrome and conditions that commonly cause peripheral neuropathy, including diabetes, uremia, or associated nutritional deficiencies * History of head injury with loss of consciousness, severe alcohol or drug abuse, psychiatric illness * Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery * Cognitive deficit severe enough to preclude informed consent * Positive pregnancy test or being of childbearing age and not using appropriate contraception * Participants with history of untreated depression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wolf Motor Function Test (WMFT), Timed Portion | baseline, post-intervention, 1-month follow-up | Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fugl Meyer Assessment Motor Score | baseline, post-intervention, 1-month follow-up | Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline. The scores can range from 0 to 66, with higher scores indicating better performance. The scores are calculated by summing the scores to the 33 individual tasks. |
| Change in Action Research Arm Test (ARAT) | baseline, post-intervention, 1-month follow-up | Values given are score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline. The ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test The maximum score on the ARTS is 57 points (possible range 0 to 57). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active PNS 2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves | 11 |
| Sham PNS 2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
peripheral nerve stimulation: Non-invasive stimulation of median, ulnar and radial nerves | 10 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Active PNS | Sham PNS | Total |
|---|---|---|---|
| Age, Continuous | 56.7 years STANDARD_DEVIATION 8.6 | 54.6 years STANDARD_DEVIATION 10.2 | 55.7 years STANDARD_DEVIATION 9.2 |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 |
Outcome results
Primary
Change in Wolf Motor Function Test (WMFT), Timed Portion
Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline
Time frame: baseline, post-intervention, 1-month follow-up
Population: Two subjects in the Sham PNS group were lost to follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active PNS | Change in Wolf Motor Function Test (WMFT), Timed Portion | Post-intervention minus baseline | -0.36 log(seconds) |
| Active PNS | Change in Wolf Motor Function Test (WMFT), Timed Portion | 1-month follow-up minus baseline | -0.37 log(seconds) |
| Sham PNS | Change in Wolf Motor Function Test (WMFT), Timed Portion | Post-intervention minus baseline | -0.18 log(seconds) |
| Sham PNS | Change in Wolf Motor Function Test (WMFT), Timed Portion | 1-month follow-up minus baseline | -0.15 log(seconds) |
Secondary
Change in Action Research Arm Test (ARAT)
Values given are score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline. The ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test The maximum score on the ARTS is 57 points (possible range 0 to 57).
Time frame: baseline, post-intervention, 1-month follow-up
Population: Two subjects from the Sham PNS group were lost to follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active PNS | Change in Action Research Arm Test (ARAT) | Post-intervention minus baseline | 9.6 units on a scale |
| Active PNS | Change in Action Research Arm Test (ARAT) | 1-month follow-up minus baseline | 11.1 units on a scale |
| Sham PNS | Change in Action Research Arm Test (ARAT) | Post-intervention minus baseline | 3.67 units on a scale |
| Sham PNS | Change in Action Research Arm Test (ARAT) | 1-month follow-up minus baseline | 4.43 units on a scale |
Secondary
Change in Fugl Meyer Assessment Motor Score
Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline. The scores can range from 0 to 66, with higher scores indicating better performance. The scores are calculated by summing the scores to the 33 individual tasks.
Time frame: baseline, post-intervention, 1-month follow-up
Population: Two subjects from the Sham PNS group were lost to follow-up.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active PNS | Change in Fugl Meyer Assessment Motor Score | Post-intervention minus baseline | 10.2 units on a scale |
| Active PNS | Change in Fugl Meyer Assessment Motor Score | 1-month follow-up minus baseline | 12.5 units on a scale |
| Sham PNS | Change in Fugl Meyer Assessment Motor Score | Post-intervention minus baseline | 5.6 units on a scale |
| Sham PNS | Change in Fugl Meyer Assessment Motor Score | 1-month follow-up minus baseline | 6.3 units on a scale |