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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05243576
Other study ID # R-1103-20
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 9, 2019
Est. completion date December 2022

Study information

Verified date February 2022
Source Kessler Foundation
Contact Leighann Martinez
Phone 973-324-3557
Email lmartinez@kesslerfoundation.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Locations

Country Name City State
United States Kessler Foundation West Orange New Jersey

Sponsors (2)

Lead Sponsor Collaborator
Kessler Foundation New Jersey Commission on Spinal Cord Research

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Electromyography (EMG) correlates EMG RMS amplitude, A single timepoint
Primary Torque Torque recorded at knee joint using biodex dynamometer A single timepoint
Secondary RMSE RMSE between EMG feedback vs torque feedback single timepoint
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