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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
University of Kentucky
About
Eligibility
Locations
Arms
Outcomes
Full info

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

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 23, 2015
    Last Updated
    September 8, 2023
    Sponsor
    University of Kentucky
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    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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