Enhancing Plasticity in Stroke Patients With Severe Motor Deficit

Completed

Phase N/A Results N/A

Trial Description

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

Interventions

  • S88 Dual Output Stimulator by Grass Technologies Device
    Intervention Desc: Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
    ARM 1: Kind: Experimental
    Label: Active peripheral nerve stimulation
    Description: 2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
    ARM 2: Kind: Experimental
    Label: Sham peripheral nerve stimulation
    Description: 2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training
    ARM 3: Kind: Experimental
    Label: Active stimulation with motor training
    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.
    ARM 4: Kind: Experimental
    Label: Sham stimulation with motor training
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Fugl Meyer Assessment Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline No
Secondary Change in Action Arm Research Test (ARAT) Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline No
Secondary Change in Wolf Motor Function Test (WMFT) Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline No

Sponsors