Driving Neuroplasticity With Nerve Stimulation and Modified CIT

Completed

Phase 1/2 Results

Trial Description

The investigators proposed to evaluate the effectiveness of sustained peripheral nerve stimulation (PNS) to enhance the therapeutic effects of a modified form CIT (mCIT).

Detailed Description

Stroke is one 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. A major goal of the research in stroke rehabilitation is to harness the capacity of the brain to reorganize after neurologic damage has occurred and thus ultimately lead to successful recovery of function. 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. A new emerging approach called constraint-induced therapy (CIT) is an intensive functional motor training and has produced promising results in the field of stroke rehabilitation. CIT involves restraining the unaffected arm with a sling or glove combined with intense task-oriented therapy of the affected side for six hours daily during 2 weeks. This pilot study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled with functional motor training to improve hand motor function. While the functional motor training follows identical principles of CIT, the length of daily training will be shortened to 4 hours daily and thus the investigators will refer in this proposal as a modified CIT. Preliminary data for this study demonstrated that peripheral nerve stimulation results in increased cortical motor excitability in normal subjects. In addition, learning and use-dependent plasticity can be substantially enhanced by a single session of 2 hours of peripheral nerve stimulation in chronic stroke patients. The goal of this study is to test the hypothesis that stroke patients treated with upper extremity peripheral nerve stimulation preceding CIT (intervention group) will have improved hand motor function compared to a group receiving lower extremity peripheral nerve stimulation and CIT (control group).

Conditions

Interventions

  • Peripheral nerve stimulation Device
    Other Names: Intramuscular Peripheral Nerve Stimulation; Intramuscular Electrical Nerve Stimulation; Smartpatch System
    Intervention Desc: Non-invasive stimulation of median, ulnar and radial nerves
    ARM 1: Kind: Experimental
    Label: Active
    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 PNS
    Description: 2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary 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
Secondary 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
Primary Change in Wolf Motor Function Test (WMFT), Timed Portion baseline, post-intervention, 1-month follow-up
Secondary Change in Fugl Meyer Assessment Motor Score baseline, post-intervention, 1-month follow-up
Secondary Change in Action Research Arm Test (ARAT) baseline, post-intervention, 1-month follow-up

Sponsors