Enhancing Plasticity in Stroke Patients With Severe Motor Deficit

NCT02633215 | Completed Results

• 1 other identifier: 0530242N
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stroke; Cerebrovascular Accident

Keywords

motor recovery; neuroplasticity; chronic; human; sensory

Outcome Measures

Primary Outcomes (1)

• Change in Fugl Meyer Assessment Motor Score

  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 Outcomes (2)

• Change in Action Arm Research Test (ARAT)

  baseline, post-intervention, 1-month follow-up

• Change in Wolf Motor Function Test (WMFT)

  baseline, post-intervention, 1-month follow-up

Study Arms (2)

Active stimulation with motor training

EXPERIMENTAL

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

Sham stimulation with motor training

ACTIVE COMPARATOR

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

Interventions

S88 Dual Output Stimulator by Grass Technologies DEVICE

Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy

Active stimulation with motor training; Sham stimulation with motor training

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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°.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lumy Sawaki: lead

Related Publications (1)

• Carrico C, Chelette KC 2nd, Westgate PM, Powell E, Nichols L, Fleischer A, Sawaki L. Nerve Stimulation Enhances Task-Oriented Training in Chronic, Severe Motor Deficit After Stroke: A Randomized Trial. Stroke. 2016 Jul;47(7):1879-84. doi: 10.1161/STROKEAHA.116.012671. Epub 2016 May 17.

  PMID: 27188405 DERIVED

MeSH Terms

Conditions

Stroke; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Results Point of Contact

• Title: Dr. Lumy Sawaki
• Organization: University of Kentucky

lsawa2@uky.edu

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 17, 2015
• Study Start: March 1, 2005
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 10, 2017
• Results First Posted: August 10, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share