Source of Hand Weakness After Stroke

Withdrawn

Phase 2 Results N/A

Trial Description

The purpose of this study is to determine whether neural block and neuromuscular electrical stimulation are effective in treating finger impairment due to stroke.

Detailed Description

The incidence of stroke-induced hemiparesis among veterans is likely to rise as this population ages. Post-stroke hemiparesis is often marked by persistent hand impairment, which adversely affects both a person's ability to work and his/her quality of life. We believe that impairment is primarily due to neural, rather than biomechanical, factors. At the muscle level, these factors relate either to the inability to activate muscles (i.e., low muscle activation) or to activate them appropriately (i.e., abnormal muscle co-activation). Currently it is unclear as to which one is largely responsible for weakness in the hand as the net mechanical effect, e.g., reduced fingertip force production, could be the same. Determination of voluntary muscle force generation could help to explain deficits in fingertip force production in specific directions, as well as to customize treatment approaches in which force generation ability of some muscles is decreased and others increased. The goal of this work is to explain the source of neurally-mediated weakness at the fingertip following hemiparetic stroke, and to design and experimentally test rehabilitation interventions that attempt to offset this weakness.
As we were refining the protocol to experimentally test a rehabilitation intervention—involving neural block and stimulation of select muscles to decrease and increase muscle force generation—it was more challenging than anticipated to locate, using ultrasound, small nerve branches to individual muscles for selective neural blocking. As a result we designed additional interventions, using a computer model, that reflected the physical limitation to implementation which could still hopefully lead to improved fingertip function. We are seeking novel approaches to locate and block small nerve branches to individual muscles for an individual muscle-based approach to rehabilitation which we expect to be an improvement over rehabilitation interventions that target groups of muscles at a time. The clinical data collected in the study and biomechanical model simulation work provide guidance for a clinical trial study in the future.

Trial Stopped: Methods unexpectedly required additional refinement that precluded subject enrollment.

Conditions

Interventions

  • Lidocaine Drug
    Intervention Desc: comparison of the effect of the drug to help improve finger function
    ARM 1: Kind: Experimental
    Label: 1
    Description: persons with severe hand impairment following hemiparetic stroke
    ARM 2: Kind: Experimental
    Label: Arm 1
    Description: persons with severe hand impairment following hemiparetic stroke
  • Muscle stimulator Device
    Intervention Desc: comparison of the effect of stimulated muscle(s) on finger function
    ARM 1: Kind: Experimental
    Label: 1
    Description: persons with severe hand impairment following hemiparetic stroke
    ARM 2: Kind: Experimental
    Label: 2
    Description: persons with severe hand impairment following hemiparetic stroke
    ARM 3: Kind: Experimental
    Label: Arm 1
    Description: persons with severe hand impairment following hemiparetic stroke
    ARM 4: Kind: Experimental
    Label: Arm 2
    Description: persons with severe hand impairment following hemiparetic stroke

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary fingertip force force measured before and after intervention (1 week later) No

Sponsors