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Driving Neuroplasticity With Nerve Stimulation and Modified CIT

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02587234
First Posted: October 27, 2015
Last Update Posted: July 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lumy Sawaki, University of Kentucky
  Purpose
The investigators proposed to evaluate the effectiveness of sustained peripheral nerve stimulation (PNS) to enhance the therapeutic effects of a modified form CIT (mCIT).

Condition Intervention Phase
Stroke Cerebrovascular Accident Device: peripheral nerve stimulation Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Driving Neuroplasticity With Nerve Stimulation and Modified Constraint-Induced Therapy

Further study details as provided by Lumy Sawaki, University of Kentucky:

Primary Outcome Measures:
  • Change in Wolf Motor Function Test (WMFT), Timed Portion [ Time Frame: 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 Outcome Measures:
  • Change in Fugl Meyer Assessment Motor Score [ Time Frame: 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) [ Time Frame: 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).



Enrollment: 21
Study Start Date: November 2006
Study Completion Date: April 2012
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
Device: peripheral nerve stimulation
Non-invasive stimulation of median, ulnar and radial nerves
Sham Comparator: Sham PNS
2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
Device: peripheral nerve stimulation
Non-invasive stimulation of median, ulnar and radial nerves

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Lumy Sawaki, Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT02587234     History of Changes
Other Study ID Numbers: R03HD049408 ( U.S. NIH Grant/Contract )
First Submitted: October 23, 2015
First Posted: October 27, 2015
Results First Submitted: June 16, 2017
Results First Posted: July 14, 2017
Last Update Posted: July 14, 2017
Last Verified: July 2017

Keywords provided by Lumy Sawaki, University of Kentucky:
motor recovery
chronic
human
sensory
afferent input
motor training

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases