Spinal Cord InjuriesNCT05243576
A Novel System for Quasi Real-Time Tracking of Neuromuscular Responses During NMES
An observational study of Spinal Cord Injuries and Incomplete Spinal Cord Injury, run by Kessler Foundation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Incomplete Spinal Cord Injury
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2019to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Leighann Martinez, 973-324-3557, lmartinez@kesslerfoundation.org
Gail Forrest, Ph.D.
About this study
Official title: 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.
- Keywords
- Neuromuscular Electrical Stimulation, Electromyography, EMG-feedback, Spinal cord injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Electromyography (EMG) correlates
EMG RMS amplitude,
Measured: A single timepoint
Torque
Torque recorded at knee joint using biodex dynamometer
Measured: A single timepoint
Secondary outcomes (1)
RMSE
RMSE between EMG feedback vs torque feedback
Measured: single timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start9 Dec 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- New Jersey Commission on Spinal Cord Research
- Responsible party
- Principal investigator, Rakesh Pilkar, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243576
- Sponsor's protocol ID
- R-1103-20
- Status last verified
- Feb 2022
- First submitted
- 7 Feb 2022
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: as per the funding agency guidelines.
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.
PubMed 27834646Momeni 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.
PubMed 34892614
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel System for Quasi Real-Time Tracking of Neuromuscular Responses During Electrical Stimulation
- ClinicalTrials.gov ID
- NCT05243576
- Acronym / sponsor ID
- R-1103-20
- Keywords
- Neuromuscular Electrical Stimulation, Electromyography, EMG-feedback, Spinal cord injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- New Jersey Commission on Spinal Cord Research
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Electromyography (EMG) correlates
Time frame: A single timepoint
EMG RMS amplitude,
Torque
Time frame: A single timepoint
Torque recorded at knee joint using biodex dynamometer
1 secondary outcome
RMSE
Time frame: single timepoint
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Background: PubMed 27834646Pilkar 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.
- Background: PubMed 34892614Momeni 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.
- Individual participant dataSharing planned: Undecided. as per the funding agency guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Incomplete Spinal Cord Injury, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leighann Martinez (973-324-3557, lmartinez@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography (EMG) correlates (time frame: A single timepoint). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05243576, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.