A Novel System for Quasi Real-Time Tracking of Neuromuscular Responses During NMES

NCT05243576 | Unknown

• 1 other identifier: R-1103-20
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Neuromuscular electrical stimulation (NMES) remains as one of the effective rehabilitation modalities for addressing recovery of neuromuscular function after a spinal cord injury (SCI). To achieve optimal effects, the NMES interventions that involve or promote voluntary efforts from SCI participants are preferred. However, these interventions are limited by the fact that the active monitoring of voluntary effort, particularly at the stimulated muscle level is unattainable. The objective of the proposed study is to develop SMARTq (Stimulated Muscle Assessment in Real-Time). This novel system will provide a quasi real-time assessment of intrinsic neuromuscular responses of a stimulated muscle during NMES. Specifically, the proposed system will consist of our novel algorithms interfaced with the EMG data acquisition hardware to process the EMG data recorded from a stimulated muscle in real-time during NMES. The term 'quasi' is used to account for the processing delay of approximately 1 to 2 seconds that may potentially occur. The proposed system will be developed and validated using the data collected from the able-bodied (AB) as well as individuals with incomplete SCI (iSCI). The applicability of the system will be evaluated on individuals with complete SCI (cSCI). Our central hypothesis is that the real-time tracking of neuromuscular responses during a train of NMES will provide valuable information on inherent neuromuscular changes, volitional participation, and neuromuscular recovery. The significance of the proposed study is that, if successful, it will deliver a highly novel system which can allow researchers and clinicians to - 1) evaluate the direct electrophysiological effects of varied combination of NMES on a stimulated muscle in real-time; 2) quantify, track and manipulate the levels of voluntary efforts or volitional drive 'on-fly' during NMES for extracting optimal benefits; 3) track the neuromuscular recovery of the stimulated muscle, particularly for cSCI populations, when any functional changes have not been observed yet; and 4) directly observe the neuromuscular fatigue derived from the electrophysiological data at the stimulated muscle. These are highly significant opportunities that can allow the clinicians and researchers to transform the current as well as future NMES interventions into highly effective training modalities as each intervention will be operated at an individual's neuromuscular level.

Conditions

Spinal Cord Injuries; Incomplete Spinal Cord Injury

Keywords

Neuromuscular Electrical Stimulation; Electromyography; EMG-feedback; Spinal cord injury

Outcome Measures

Primary Outcomes (2)

• Electromyography (EMG) correlates

  EMG RMS amplitude,

  A single timepoint

• Torque

  Torque recorded at knee joint using biodex dynamometer

  A single timepoint

Secondary Outcomes (1)

• RMSE

  single timepoint

Study Arms (3)

incomplete SCI

1\) Be motor incomplete; 2) Be AIS classified as C or D; 3) have a neurological level of injury from C6 - T6; 4) Have LEMS score \> 10; 5) Have Modified Ashworth Scale ≤ 3 for spasticity. Additional - 1) Be able to tolerate electrical stimulation; 2) Be able and willing to comply with study requirements, procedures and verbal instructions; 3) Have been diagnosed with a spinal cord injury by a physician.

complete SCI

1\) Be chronic (≥ 1-year post injury); 2) AIS classified as A or B motor-complete; Additional - 1) Be able to tolerate electrical stimulation; 2) Be able and willing to comply with study requirements, procedures and verbal instructions; 3) Have been diagnosed with a spinal cord injury by a physician.

Able-bodied

1\) Be able and willing to tolerate electrical stimulation; 2) Be able and willing to comply with study requirements, procedures and verbal instructions.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

There will be five participants in each of the three study groups: able-bodied (AB), incomplete spinal cord injury (iSCI), and complete spinal cord injury (cSCI). All participants will be between the ages of 18 and 60 years old. Individuals will be recruited through the Kessler Institute for Rehabilitation System, which includes 3 hospitals and 75 outpatient clinics.

You may qualify if:

• SCI generic criteria - 1) Be able to tolerate electrical stimulation; 2) Be able and willing to comply with study requirements, procedures and verbal instructions; 3) Have been diagnosed with a spinal cord injury by a physician.
• Individuals with complete SCI. 1) Be chronic (≥ 1-year post injury); 2) AIS classified as A or B motor-complete;
• Individuals with incomplete SCI. 1) Be motor incomplete; 2) Be AIS classified as C or D; 3) have a neurological level of injury from C6 - T6; 4) Have LEMS score \> 10; 5) Have Modified Ashworth Scale ≤ 3 for spasticity.

Sponsors & Collaborators

• Kessler Foundation: lead
• New Jersey Commission on Spinal Cord Research: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

Related Publications (2)

• Pilkar R, Yarossi M, Ramanujam A, Rajagopalan V, Bayram MB, Mitchell M, Canton S, Forrest G. Application of Empirical Mode Decomposition Combined With Notch Filtering for Interpretation of Surface Electromyograms During Functional Electrical Stimulation. IEEE Trans Neural Syst Rehabil Eng. 2017 Aug;25(8):1268-1277. doi: 10.1109/TNSRE.2016.2624763. Epub 2016 Nov 3.

  PMID: 27834646 BACKGROUND

• Momeni K, Pilkar R, Ravi M, Forrest GF. Isolating Transcutaneous Spinal Cord Stimulation Artifact to Identify Motor Response during Walking. Annu Int Conf IEEE Eng Med Biol Soc. 2021 Nov;2021:6569-6572. doi: 10.1109/EMBC46164.2021.9630099.

  PMID: 34892614 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Leighann Martinez

CONTACT

973-324-3557; lmartinez@kesslerfoundation.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 17, 2022
• Study Start: December 9, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 17, 2022

Record last verified: 2022-02

Locations

US (1)