Enhancing Plasticity in Stroke Patients With Severe Motor Deficit

NCT ID: NCT02633215

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2013-12-31

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.

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.

Conditions

Stroke; Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

S88 Dual Output Stimulator by Grass Technologies

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

S88 Dual Output Stimulator by Grass Technologies

Intervention Type: DEVICE

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

Interventions

S88 Dual Output Stimulator by Grass Technologies

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

Intervention Type: DEVICE

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 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lumy Sawaki

OTHER

Sponsor Role: lead

Responsible Party

Lumy Sawaki

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 27188405 (View on PubMed)

Other Identifiers

0530242N

Identifier Type: -

Identifier Source: org_study_id