Driving Neuroplasticity With Nerve Stimulation and Modified CIT
Primary Purpose
Stroke, Cerebrovascular Accident
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
peripheral nerve stimulation
Sponsored by

About this trial
This is an interventional basic science trial for Stroke focused on measuring motor recovery, chronic, human, sensory, afferent input, motor training
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active
Sham PNS
Arm Description
2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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).
Full Information
NCT ID
NCT02587234
First Posted
October 23, 2015
Last Updated
September 8, 2023
Sponsor
University of Kentucky
1. Study Identification
Unique Protocol Identification Number
NCT02587234
Brief Title
Driving Neuroplasticity With Nerve Stimulation and Modified CIT
Official Title
Driving Neuroplasticity With Nerve Stimulation and Modified Constraint-Induced Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kentucky
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular Accident
Keywords
motor recovery, chronic, human, sensory, afferent input, motor training
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
Arm Title
Sham PNS
Arm Type
Sham Comparator
Arm Description
2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
Intervention Type
Device
Intervention Name(s)
peripheral nerve stimulation
Intervention Description
Non-invasive stimulation of median, ulnar and radial nerves
Primary Outcome Measure Information:
Title
Change in Wolf Motor Function Test (WMFT), Timed Portion
Description
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
Secondary Outcome Measure Information:
Title
Change in Fugl Meyer Assessment Motor Score
Description
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
Title
Change in Action Research Arm Test (ARAT)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
26945226
Citation
Carrico C, Chelette KC 2nd, Westgate PM, Salmon-Powell E, Nichols L, Sawaki L. Randomized Trial of Peripheral Nerve Stimulation to Enhance Modified Constraint-Induced Therapy After Stroke. Am J Phys Med Rehabil. 2016 Jun;95(6):397-406. doi: 10.1097/PHM.0000000000000476.
Results Reference
derived
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Driving Neuroplasticity With Nerve Stimulation and Modified CIT
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