Novel Brain Signal Feedback Paradigm to Enhance Motor Learning After Stroke

Recruiting

Phase N/A Results N/A

Trial Description

Stroke (795,000/year in the US and 30 million existing stroke survivors in the world) damages brain neural structures that control coordinated upper limb movement. To most effectively target the brain damage, interventions should be directed so as to restore brain control serving coordination of peripheral neuromuscular function. Currently, there is a lack of a transformative intervention strategy, and only limited efficacy is seen in response to neural rehabilitation that is only peripherally-directed (limbs e.g.) or only directed at the brain. This study will employ a novel neural feedback approach with a closed-loop, real-time paradigm to engage and retrain existing brain function after stroke. Real-time functional magnetic resonance imaging (rtfMIR) provides neural feedback with the advantage of precisely identifying the location of brain activity for multiple cognitive and emotional tasks. However, the rtfMRI is costly and precludes motor learning that requires sitting and engaging the upper limb in complex motor tasks during imaging acquisition. In contrast, real-time functional near-infrared spectroscopy (rtfNIRS), although not as spatially precise as rtfMRI, offers a low-cost, portable solution to provide brain neural feedback during motor learning. This proposal will utilize both technologies in a hybrid, sequential motor learning protocol. Moreover, the study protocol will also simultaneously involve both central effective signals (through neural feedback) and peripheral affective signals by employing neutrally-triggered functional electrical stimulation (FES)-assisted coordination practice, which produces peripherally-induced affective signals from muscle and joint receptors. This novel combination intervention protocol will engage the central nervous system, motor effective pathway training along with induction of affective signal production (FES-assisted practice), all of which will be implemented within the framework of evidence-based motor learning principles.

Detailed Description

This study aims to develop and test an innovative protocol for recovery of wrist extension after stroke, using a combination of rtfMRI, rtfNIRS, FES, and motor learning.
Aim I. Test the innovative coordination training protocol of combination rtfMRI/rtfNIRS central neural feedback and peripherally-directed, neurally-triggered FES-assisted coordination practice implemented within a framework of motor learning principles.
Hypothesis 1. Chronic stroke survivors will show significant improvement in upper limb function in response to the combined rtfMRI/rtfNIRS central neural feedback; peripherally-directed FES-assisted coordination practice of wrist and finger extension; and whole arm/hand motor learning (Primary measure: Arm Motor Abilities Test (AMAT); secondary measures include: AMAT Wrist/Hand subscale; Fugl-Meyer upper limb coordination; and quality of life (Craig Handicap Assessment Rating Tool)).
Secondary Aim II. Measure changes in brain activation patterns in response to the proposed treatment.
Objective: During attempted wrist and finger extension, the investigators will measure baseline and treatment response according to brain activation volume, intensity, centroid location, and white matter integrity.

Conditions

Interventions

  • Neural feedback plus FES and motor training Other
    Intervention Desc: Neural feedback involves sequential rtfMRI (phase I) and rtfNIRS (phase II) training; Neurally-triggered, peripherally-directed FES-assist practice of wrist and finger extension will be combined with rtfNIRS training in Phase II; 46 additional motor learning sessions without brain neural feedback will be provided in Phase III.
    ARM 1: Kind: Experimental
    Label: Stroke Group
    Description: Intervention: Stroke subjects will receive neural feedback plus FES and motor learning intervention that spans 3 phases and up to a total of 60 sessions. Phase I: real-time fMRI neural feedback training; Phase II: rtfNIRS-based neural feedback learning (built upon self-regulation strategies learned in Phase I and also assisted by neurally-triggered, peripherally-directed FES motor practice of wrist and finger extension); Phase III: motor learning minus neural feedback for an additional 46 sessions; Phase IV: follow-up testing at 3 months after-treatment ends

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Arm Motor Abilities Test (AMAT) Through study completion, an average of 2 years No

Sponsors