Enhancing Plasticity in Stroke Patients With Severe Motor Deficit

Lumy Sawaki

Status: Completed

Conditions: Cerebrovascular Accident; Stroke

Treatments: Device: S88 Dual Output Stimulator by Grass Technologies

Study type: Interventional

Funder types: Other

Identifiers

NCT02633215

0530242N

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

36 participants in 2 patient groups

Active stimulation with motor training

Experimental group

Description:

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.

Treatment:

Device: S88 Dual Output Stimulator by Grass Technologies

Sham stimulation with motor training

Active Comparator group

Description:

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.

Treatment:

Device: S88 Dual Output Stimulator by Grass Technologies