Neuro-Intermuscular Coordination Enhancement (NICE) Rehabilitation Through Human-Machine Interaction in Chronic Stroke

Official title

Neuro-Intermuscular Coordination Enhancement (NICE) Rehabilitation

Overview

The objective of this study is to develop Neuro-Intermuscular Coordination Enhancement (NICE) rehabilitation, a novel neuromuscular control signal-guided strategy that visually guides stroke patients to individually activate motor modules through human-machine interaction. Ultimately, the development will lead to better clinical motor recovery, better quality of life, and lowered healthcare costs associated with the impairment.

Detailed description

Stroke is the leading cause of severe long-term disability, affecting 9.4 million Americans. Each year around 800,000 people suffer a stroke even in the USA. Chronic upper extremity motor impairment is a major contributing factor to disability; functional use of the affected UE in daily life is a key factor for increased independence, return to work, and overall quality of life. Thus, effective and innovative treatment to address long-term disability is both a major public health need and an economic necessity.

This study is an early-stage, randomized controlled rehabilitation trial designed to evaluate the clinical effects, feasibility, transfer of therapeutic gains, and exploratory neurophysiological correlates of Neuro-Intermuscular Coordination Enhancement (NICE) in individuals with chronic stroke and upper-extremity hemiparesis.

Forty-eight participants will be enrolled to obtain a target analyzable sample of 40 participants. Eligible participants will be randomized to either: (1) NICE, a motor module-guided rehabilitation intervention using isometric human-machine interaction and real-time EMG-based visual feedback to retrain impaired intermuscular coordination patterns; or (2) an active comparator consisting of dose-matched EMG amplitude biofeedback exercise. Both interventions will be delivered three times per week for six weeks (18 total sessions). Participants will complete assessments at baseline, immediately post-intervention, and at 10- and 18-week follow-up time points.

Outcomes will include standardized clinical measures of upper-extremity motor impairment and function, measures of intermuscular coordination derived from surface electromyography, kinematic measures obtained during untrained dynamic motor tasks, and EEG-based measures of brain activity and connectivity.

The primary objective is to determine whether NICE improves upper-extremity motor impairment relative to the active comparator. Secondary objectives are to evaluate intervention-related changes in intermuscular coordination and transfer of therapeutic gains to untrained motor behaviors. Exploratory objectives are to characterize rehabilitation-associated neurophysiological changes and examine relationships among EEG-derived biomarkers, intermuscular coordination, and clinical recovery outcomes.

Interventions

• Other Neuromuscular coordination enhancement (NICE) intervention
  Neuro-Intermuscular Coordination Enhancement (NICE) is a motor module-guided rehabilitation intervention designed to improve upper-extremity motor recovery after stroke by retraining impaired intermuscular coordination patterns. Participants perform isometric upper-extremity force-generation tasks using a human-machine interface while receiving real-time visual feedback derived from motor module recruitment signals calculated from surface electromyography (EMG). Individualized motor module targe
• Other EMG Amplitude Biofeedback Exercise
  EMG Amplitude Biofeedback Exercise is an active comparator rehabilitation intervention designed to improve upper-extremity motor function after stroke through targeted muscle activation training. Participants perform isometric upper-extremity exercises using a human-machine interface with real-time EMG amplitude-based visual feedback. Individualized muscle activation targets derived from the less-affected upper extremity guide training of the more-affected upper extremity. Participants will comp

Primary outcome measures

• Fugl-Meyer Assessment (FMA) score [Time frame: Baseline, six- week, 10-week, and 18-week follow-ups.]

Secondary outcome measures (8)

• Similarity Score of Intermuscular Coordination Patterns (or Motor Modules) [Time frame: Baseline, six- week, 10-week, and 18-week follow-ups.]
• Kinematic Synergy Similarity Score [Time frame: Baseline, six-week, 10-week, and 18-week follow-ups.]
• Pairwise joint angle-to-angle correlation value [Time frame: Baseline, six- week, 10-week, and 18-week follow-ups.]
• Active range of motion [Time frame: Baseline, six-week, 10-week, and 18-week follow-ups.]
• EEG Spectral power ratios [Time frame: Baseline and six-week follow-up.]
• EEG-derived Brain Symmetry Index [Time frame: Baseline and six-week follow-up.]
• Cortico-muscular connectivity [Time frame: Baseline and six-week follow-up.]
• Cortico-cortical connectivity [Time frame: Baseline and six-week follow-up.]

Eligibility criteria

Inclusion criteria for individuals after stroke are:

• Hemiparetic chronic stroke survivors more than 6 months after stroke onset
• Adults aged 21-80 years, including both female and male participants
• Individuals with a single unilateral ischemic or hemorrhagic stroke
• Individuals with Upper Extremity Fugl-Meyer Assessment score between 10 and 59 out of 66
• Individuals who have not received botulinum toxin injections in the upper extremity within the past 3 months
• Individuals without severe spasticity, defined as Modified Ashworth Scale score ≤3 at the elbow and shoulder

Exclusion criteria for individuals after stroke are:

• Individuals younger than 21 years of age or older than 80 years of age
• Individuals with an orthopedic disorder involving the upper limbs
• Individuals unable to produce voluntary upper-extremity muscle EMG activity;
• Individuals with cognitive impairment sufficient to interfere with informed consent or successful completion of the protocol, assessed using the Montreal Cognitive Assessment or other IRB-approved screening procedures.
• Individuals whose stroke-affected arm has an intermuscular coordination pattern similarity score >0.80 relative to the non-affected arm

Inclusion criteria for healthy individuals are:

• Healthy adults aged 21-80 years, including both female and male participants
• Individuals with no known neurological or orthopedic injuries

Exclusion criteria for healthy individuals are:

• Individuals younger than 21 years of age or older than 80 years of age
• Individuals with known neurological disorders
• Individuals with orthopedic injuries or conditions affecting upper-extremity movement
• Individuals unable to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Houston — Houston

Publications

• Seo G, Kishta A, Mugler E, Slutzky MW, Roh J. Myoelectric interface training enables targeted reduction in abnormal muscle co-activation. J Neuroeng Rehabil. 2022 Jul 1;19(1):67. doi: 10.1186/s12984-022-01045-z. PMID 35778757
• Li S. Stroke Recovery Is a Journey: Prediction and Potentials of Motor Recovery after a Stroke from a Practical Perspective. Life (Basel). 2023 Oct 15;13(10):2061. doi: 10.3390/life13102061. PMID 37895442
• Roh J, Cheung VC, Bizzi E. Modules in the brain stem and spinal cord underlying motor behaviors. J Neurophysiol. 2011 Sep;106(3):1363-78. doi: 10.1152/jn.00842.2010. Epub 2011 Jun 8. PMID 21653716
• Dewald JP, Sheshadri V, Dawson ML, Beer RF. Upper-limb discoordination in hemiparetic stroke: implications for neurorehabilitation. Top Stroke Rehabil. 2001 Spring;8(1):1-12. doi: 10.1310/WA7K-NGDF-NHKK-JAGD. PMID 14523747
• Nordin AD, Hairston WD, Ferris DP. Faster Gait Speeds Reduce Alpha and Beta EEG Spectral Power From Human Sensorimotor Cortex. IEEE Trans Biomed Eng. 2020 Mar;67(3):842-853. doi: 10.1109/TBME.2019.2921766. Epub 2019 Jun 13. PMID 31199248
• Roh J, Beer RF, Lai A, Rho M, Karvelas KR, Nader AM, Kendall MC, Rymer WZ. The Effects of Selective Muscle Weakness on Muscle Coordination in the Human Arm. Appl Bionics Biomech. 2018 Sep 19;2018:5637568. doi: 10.1155/2018/5637568. eCollection 2018. PMID 30402139
• Park JH, Lee H, Kwon HJ, Shin JH, Roh J, Park HS. Feasibility of Isokinetic Training to Modify Coupling of Upper Limb Muscle Synergy Activation in Stroke-affected Upper Limb. Annu Int Conf IEEE Eng Med Biol Soc. 2023 Jul;2023:1-4. doi: 10.1109/EMBC40787.2023.10339985. PMID 38082751
• Portilla-Jimenez M, Seo G, Houston M, Hong YNG, Li S, Park HS, Zhang Y, Roh J. Improving impaired intermuscular coordination after stroke through synergy-guided human-machine interaction: a pilot study. Annu Int Conf IEEE Eng Med Biol Soc. 2024 Jul;2024:1-4. doi: 10.1109/EMBC53108.2024.10782001. PMID 40031505

Identifiers

NCT: NCT07531264 · STUDY00001333-NICE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗