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Clinical Trials/NCT02587234
NCT02587234
Completed
Phase 1

Driving Neuroplasticity With Nerve Stimulation and Modified Constraint-Induced Therapy

University of Kentucky0 sites21 target enrollmentNovember 2006

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Kentucky
Enrollment
21
Primary Endpoint
Change in Wolf Motor Function Test (WMFT), Timed Portion
Status
Completed
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 2006
End Date
April 2012
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lumy Sawaki

Associate Professor

University of Kentucky

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.

Outcomes

Primary Outcomes

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 Outcomes

  • Change in Action Research Arm Test (ARAT)(baseline, post-intervention, 1-month follow-up)
  • Change in Fugl Meyer Assessment Motor Score(baseline, post-intervention, 1-month follow-up)

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