Enhancing Plasticity in Stroke Patients With Severe Motor Deficit

July 11, 2017 updated by: Lumy Sawaki

Enhancing Cortical Plasticity With Nerve Stimulation in Stroke Patients With Severe Motor Deficit

This study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled with functional motor training, to improve hand motor function in poorly recovered stroke patients. The central hypothesis is that stroke patients with severe motor deficit receiving hand nerve stimulation and intensive task-oriented therapy will have improved motor function compared to patients receiving sham nerve stimulation and task-oriented therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stroke is one of 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. 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 especially in poorly recovered stroke patients. This study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled with functional motor training, to improve hand motor function in stroke patients with severe motor deficit. The central hypothesis is that stroke patients with severe motor deficit receiving hand nerve stimulation and intensive task-oriented therapy will have improved motor function compared to patients receiving sham nerve stimulation and task-oriented therapy, and the degree of this behaviorally-measured effect will correlate with the neurophysiological effect measured by transcranial magnetic stimulation.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 NOT 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active stimulation with motor training
2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
Device: S88 Dual Output Stimulator by Grass Technologies
Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
Active Comparator: Sham stimulation with motor training
2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies.
Device: S88 Dual Output Stimulator by Grass Technologies
Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fugl Meyer Assessment Motor Score
Time Frame: baseline, post-intervention, 1-month follow-up
Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.
baseline, post-intervention, 1-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Wolf Motor Function Test (WMFT)
Time Frame: baseline, post-intervention, 1-month follow-up
Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. Each task is scored as amount of time taken to complete a task, which may range from just over 0 to 120 seconds. If the subject is unable to complete the task within 120 seconds, a score of 121 seconds is given. The scores from the 15 individual tasks are averaged, then the log is taken, resulting in the overall score. Therefore, the larger the score, the longer required to perform the tasks. Negative changes in score indicate that a subject, on average, was able to complete the tasks faster at post-intervention or at 1-month follow-up than at baseline.
baseline, post-intervention, 1-month follow-up
Change in Action Arm Research Test (ARAT)
Time Frame: baseline, post-intervention, 1-month follow-up
Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. The possible scores range from 0 to 57, with higher scores indicating better performance.
baseline, post-intervention, 1-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lumy Sawaki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 11, 2015

First Submitted That Met QC Criteria

December 14, 2015

First Posted (Estimate)

December 17, 2015

Study Record Updates

Last Update Posted (Actual)

August 10, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0530242N

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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