Back to resultsPeripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke
Primary Purpose
Stroke
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peripheral nerve stimulation (PNS)
Intensive upper extremity motor training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring neuroplasticity, rehabilitation, peripheral nerve stimulation, motor training
Eligibility Criteria
Inclusion Criteria:
- Have severe upper extremity motor deficit after a single stroke
- Stroke onset at least 12 months ago
Exclusion Criteria:
- Addition or change in the dosage of drugs known to exert detrimental effects on motor recovery within 3 months of enrollment
- 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
Sites / Locations
- University of Kentucky at Cardinal Hill Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
Active PNS during training
Active PNS before training
Sham PNS during training
Arm Description
Individuals in this group will receive active PNS while participating in 2 hours of motor training of the affected arm.
Individuals in this group will receive 2 hours of active PNS before participating in 2 hours of motor training of the affected arm.
Individuals in this group will receive 2 hours of sham PNS while participating in 2 hours of motor training of the affected arm.
Outcomes
Primary Outcome Measures
Fugl-Meyer Assessment
This is a quantitative measure of motor recovery, coordination, and speed.
Secondary Outcome Measures
Action Research Arm Test
This test measures changes in the upper extremity and consists of four specific tests to measure grasp, grip, pinch, and gross movement.
Stroke Impact Scale
This is a self-report that assesses strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, and participation.
Cortical motor map volume
This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm or hand.
Full Information
NCT ID
NCT04576013
First Posted
September 29, 2020
Last Updated
February 23, 2021
Sponsor
University of Kentucky
1. Study Identification
Unique Protocol Identification Number
NCT04576013
Brief Title
Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke
Official Title
Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
PI is leaving the university.
Study Start Date
February 23, 2016 (Actual)
Primary Completion Date
February 22, 2021 (Actual)
Study Completion Date
February 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kentucky
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Subjects will receive non-invasive stimulation of nerves on their arm and intensive motor training of their arm. The timing of the stimulation in relation to the training will vary by group.
Detailed Description
This study will look at the differences in improvement of hand and arm function when nerve stimulation is applied at different times in relation to motor training. The nerve stimulation, called peripheral nerve stimulation (PNS), is non-invasive and painless. Subjects in the study may receive strong or mild PNS. Subjects will also vary by whether PNS is delivered for 2 hours before the 2 hours of motor training, or during the 2 hours of motor training. Which level of stimulation and its timing will be determined randomly for each subject.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
neuroplasticity, rehabilitation, peripheral nerve stimulation, motor training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active PNS during training
Arm Type
Experimental
Arm Description
Individuals in this group will receive active PNS while participating in 2 hours of motor training of the affected arm.
Arm Title
Active PNS before training
Arm Type
Active Comparator
Arm Description
Individuals in this group will receive 2 hours of active PNS before participating in 2 hours of motor training of the affected arm.
Arm Title
Sham PNS during training
Arm Type
Sham Comparator
Arm Description
Individuals in this group will receive 2 hours of sham PNS while participating in 2 hours of motor training of the affected arm.
Intervention Type
Device
Intervention Name(s)
Peripheral nerve stimulation (PNS)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive upper extremity motor training
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment
Description
This is a quantitative measure of motor recovery, coordination, and speed.
Time Frame
Baseline, Immediately post-intervention
Secondary Outcome Measure Information:
Title
Action Research Arm Test
Description
This test measures changes in the upper extremity and consists of four specific tests to measure grasp, grip, pinch, and gross movement.
Time Frame
Baseline, Immediately post-intervention
Title
Stroke Impact Scale
Description
This is a self-report that assesses strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, and participation.
Time Frame
Baseline, Immediately post-intervention
Title
Cortical motor map volume
Description
This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm or hand.
Time Frame
Baseline, Immediately post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have severe upper extremity motor deficit after a single stroke
Stroke onset at least 12 months ago
Exclusion Criteria:
Addition or change in the dosage of drugs known to exert detrimental effects on motor recovery within 3 months of enrollment
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
Facility Information:
Facility Name
University of Kentucky at Cardinal Hill Rehabilitation Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke
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