Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke

Recruiting

Phase 1 Results N/A

Trial Description

This is a small pilot randomized controlled trial which will enroll both subacute (<6 mos) and chronic (>6 mos) stroke survivors (n=18 total) with dorsiflexion weakness. The subjects will be stratified based on interval post-stroke and baseline level of motor impairment and then randomized to Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) versus control. The primary objective of this study is to compare the effect of 6-weeks of lower extremity CCNMES, applied in an anti-phase application, on motor impairment and functional mobility to a control group; the effect of interval post-stroke, subacute (early) versus chronic (late) post-stroke, will be assessed. The secondary objective is to determine the effect of 6-weeks of lower extremity anti-phase CCNMES on functional magnetic resonance imaging (MRI) cortical activation patterns using an ankle dorsiflexion paradigm. The specific use of functional MRI as an outcome measure is to explore a central mechanism for between-group differences.
AIM 1: Determine the effect of lower extremity CCNMES, applied in an anti-phase application, on motor impairment and functional mobility in hemiparesis compared to a control group; assess the effect of application in the subacute (< 6 mos, early) versus chronic (> 6 mos, late) post-stroke period.
Hypothesis: Subjects randomized to the lower extremity CCNMES group will achieve greater improvement in motor impairment and functional mobility as compared to the control group; subjects in the subacute post-stroke period will achieve greater improvement than subjects in the chronic post-stroke period.
AIM 2: Demonstrate change in functional MRI activation patterns using an ankle dorsiflexion paradigm following the lower extremity anti-phase CCNMES intervention.
Hypothesis: Subjects randomized to the anti-phase CCNMES group will demonstrate change in functional MRI cortical activation patterns which differs from the control group; subjects in subacute post-stroke period will demonstrate change in functional MRI activation patterns that are distinct from change noted in chronic subjects.
AIM 3: Define a central mechanism for post-stroke motor and functional recovery associated with lower extremity anti-phase CCNMES.
Hypothesis: Change in functional MRI cortical activation patterns following anti-phase CCNMES intervention will correlate with change in motor impairment and functional mobility.

Conditions

Interventions

  • Contralaterally Controlled Neuromuscular Electrical Stimulation Device
    ARM 1: Kind: Experimental
    Label: CCNMES
    Description: Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.
  • Cyclic Neuromuscular Electrical Stimulation Device
    ARM 1: Kind: Experimental
    Label: Cyclic NMES
    Description: Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Walking Speed Baseline walking speed and change from baseline at 6 weeks (end of treatment) No
Secondary Ankle Movement Tracking Error Baseline ankle movement tracking error and change from baseline at 6 weeks (end of treatment) No
Secondary Active Range Of Motion (ROM) of Ankle Baseline active range of motion of ankle and change from baseline at 6 weeks (end of treatment) No
Secondary Fugl-Meyer Lower Extremity Motor Assessment Baseline Fugl-Meyer lower extremity motor assessment and change from baseline at 6 weeks (end of treatment) No
Secondary Modified Emory Functional Ambulation Profile (MEFAP) Baseline modified Emory functional ambulation profile and change from baseline at 6 weeks (end of treatment) No

Sponsors