Novel Brain Signal Feedback Paradigm to Enhance Motor Learning After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      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: Pre-/post-treatment change score in Arm Motor
      Abilities Test - function domain (AMAT - F); secondary measure: Pre/post-treatment change
      score in Fugl-Meyer upper limb coordination.
    

Intervention name(s): Neural feedback plus FES and motor training
Intervention type(s): Other
Intervention description(s): We are not testing the feasibility of the imaging methods; that has been well established and is used clinically. We are testing the feasibility of using neural feedback clinical imaging methods in a neural feedback paradigm which 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; up to 60 total sessions, including additional motor learning sessions without brain neural feedback will be provided in Phase III.
Intervention model: Single Group Assignment
Intervention model description: feasibility testing
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: chronic stroke; functional MRI; functional NIRS; motor learning; FES; upper extremity; neural feedback; arm/hand functional training