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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries; Incomplete Spinal Cord Injury

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

• Study Contact: Name: Leighann Martinez; Phone Number: 973-324-3557; Email: lmartinez@kesslerfoundation.org

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Recruiting
      • Kessler Foundation
      • Contact: Leighann Martinez; Phone Number: 973-324-3557; Email: lmartinez@kesslerfoundation.org
      • Sub-Investigator: Gail Forrest, Ph.D.
      • Sub-Investigator: Kamyar Momeni, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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.

Inclusion criteria for the able-bodied group. 1) Be able and willing to tolerate electrical stimulation; 2) Be able and willing to comply with study requirements, procedures and verbal instructions.

Exclusion Criteria:

Exclusion criteria for all participants. 1) Pregnancy at time of study; 2) History of femur or tibia fracture; 3) Diagnosis with any major cardiovascular or pulmonary disease; 4) Diagnosis with obesity; 5) Diagnosis of lower extremity deep vein thrombosis; 6) Presence of skin lesions or breakdown; 7) Use of electronic implants; 8) Any history of major gastrointestinal problems; 9) difficulty following or responding to commands that would limit the study participation; 10) Currently enrolled in another research study or therapy (from a licensed physical therapist) that is likely to affect participation in this research study.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromyography (EMG) correlates	EMG RMS amplitude,	A single timepoint
Torque	Torque recorded at knee joint using biodex dynamometer	A single timepoint

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RMSE	RMSE between EMG feedback vs torque feedback	single timepoint

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Collaborators: New Jersey Commission on Spinal Cord Research

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Neuromuscular Electrical Stimulation; Electromyography; Spinal cord injury; EMG-feedback
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: R-1103-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: as per the funding agency guidelines.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No