Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke
NCT ID: NCT04576013
Last Updated: 2021-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
12 participants
INTERVENTIONAL
2016-02-23
2021-02-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active PNS during training
Individuals in this group will receive active PNS while participating in 2 hours of motor training of the affected arm.
Peripheral nerve stimulation (PNS)
Non-invasive stimulation is applied to 3 nerves of the arm. The stimulation will be set at a level that is not painful or uncomfortable.
Intensive upper extremity motor training
Active PNS before training
Individuals in this group will receive 2 hours of active PNS before participating in 2 hours of motor training of the affected arm.
Peripheral nerve stimulation (PNS)
Non-invasive stimulation is applied to 3 nerves of the arm. The stimulation will be set at a level that is not painful or uncomfortable.
Intensive upper extremity motor training
Sham PNS during training
Individuals in this group will receive 2 hours of sham PNS while participating in 2 hours of motor training of the affected arm.
Peripheral nerve stimulation (PNS)
Non-invasive stimulation is applied to 3 nerves of the arm. The stimulation will be set at a level that is not painful or uncomfortable.
Intensive upper extremity motor training
Interventions
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Peripheral nerve stimulation (PNS)
Non-invasive stimulation is applied to 3 nerves of the arm. The stimulation will be set at a level that is not painful or uncomfortable.
Intensive upper extremity motor training
Eligibility Criteria
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Inclusion Criteria
* Stroke onset at least 12 months ago
Exclusion Criteria
* Untreated depression
* History of multiple strokes
* History of seizure
* History of head injury with loss of consciousness, severe alcohol or drug abuse, or psychiatric illness
* Positive pregnancy test or being of childbearing age and not using appropriate contraception
* Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure, and surgical clips in or near the brain
* Cardiac or neural pacemakers or implanted medication pumps
* Receptive aphasia
18 Years
ALL
No
Sponsors
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University of Kentucky
OTHER
Responsible Party
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Lumy Sawaki
Associate Professor
Locations
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University of Kentucky at Cardinal Hill Rehabilitation Hospital
Lexington, Kentucky, United States
Countries
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Other Identifiers
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44185
Identifier Type: -
Identifier Source: org_study_id
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