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Prediction of Muscle Responsiveness to FES Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05462925
Recruitment Status : Recruiting
First Posted : July 18, 2022
Last Update Posted : July 25, 2022
Sponsor:
Collaborator:
Wings for Life
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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Brief Summary:

Reduced arm and hand function has a significant impact on independence and quality of life after spinal cord injury. Functional electrical stimulation therapy (FES-T) is a treatment that can produce improvements in reaching and grasping function after neurological injuries. However, not all paralyzed muscles respond equally well to the therapy. Currently, therapists cannot predict which muscles will respond, limiting their ability to create a personalized therapy plan that can maximize outcomes while making the best use of the limited treatment time available. The objective of this study is to develop a diagnostic method that will allow therapists to quickly and easily screen muscles in the clinic, in order to predict how they will respond to FES-T.

Participants with cervical spinal cord injury will receive FES-T through the Rocket Family Upper Extremity Clinic at the Toronto Rehabilitation Institute - University Health Network. Muscles receiving training will undergo a electrophysiological examination before the start of therapy, and will then be tracked for strength recovery over the course of 30 sessions. Lastly, signal processing and machine learning techniques will be applied to the electrophysiological data to predict the recovery profile of each muscle.

The significance of this work will be to provide personalized therapy planning in FES-T, leading to more effective use of healthcare resource as well as improved outcomes.


Condition or disease Intervention/treatment Phase
Spinal Cord Injury Cervical Device: Functional electrical stimulation therapy. Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This prognostic study examines how baseline measurements predict therapy response in a single group of participants.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Point-of-care Prediction of Muscle Responsiveness to Functional Electrical Stimulation Therapy During Neurorehabilitation (Sub-study)
Actual Study Start Date : July 20, 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Functional electrical stimulation therapy
Participants will receive 30 sessions of upper limb functional electrical stimulation therapy. Sessions will be 1 hour in length and take place 3-5 times per week.
 Device: Functional electrical stimulation therapy.
Functional electrical stimulation therapy will be delivered using the MyndMove system (MyndTec, Inc., Mississauga, Canada).


Outcome Measures
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Primary Outcome Measures :
  1. Muscle strength recovery profile [ Time Frame: Muscle strength assessed at each of 30 therapy sessions (3-5 sessions per week). ]
    Change over time in manual muscle testing conducted on each treated muscle.


Secondary Outcome Measures :
  1. Surface electromyography signal features [ Time Frame: Baseline (required). End of therapy (6-10 weeks; optional). ]
    Surface electromyography of treated muscles will be conducted at baseline. A set of signal features will be extracted for use in predictive modeling (examples include Hudgins' time-domain feature set, autoregressive coefficients, and frequency domain features). An optional second assessment will occur at the end of the 30 therapy sessions.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cervical spinal cord injury
  • Paralysis or paresis in at least one upper extremity
  • At least 6 months post SCI
  • Able to understand and follow instructions
  • Able to tolerate being in a seated position for a least one hour required to deliver upper limb therapy
  • Willing to attend treatment sessions and all assessment sessions
  • Able to understand and provide informed consent
  • Male and female participants ≥ 18 years of age at the time of enrollment

Exclusion Criteria:

  • Previous history of any other neuromuscular disorder or conditions that may affect motor response
  • Upper extremity injury or condition prior to SCI that limits the function of the hand or arm
  • In the judgment of the medical provider, the participant has medical complications that may interfere with the execution of the study
  • Currently enrolled in another upper limb study and/ or has received MyndMove Therapy within the past 3 months
  • Botulinum toxin injection into affected upper extremity and the muscle targeted by MyndMove® therapy within 3 months prior to the study start. No botulinum toxin injections in the upper extremity during the study treatment.
  • Females who are pregnant or planning to become pregnant in the duration of the trial
  • Regional disorder of the upper extremities such as fracture, dislocation, or joint contractures to less than 50% of the expected range of motion
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05462925


Contacts
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Contact: Sharmini Atputharaj 1-416-597-3422 ext 6119 Sharmini.Atputharaj@uhn.ca

Locations
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Canada, Ontario
Toronto Rehabilitation Institute - University Health Network Recruiting
Toronto, Ontario, Canada, M4G 3V9
Contact: Sharmini Atputharaj    1-416-597-3422 ext 6119    Sharmini.Atputharaj@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Wings for Life
Investigators
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Principal Investigator: José Zariffa, PhD University Health Network, Toronto
Principal Investigator: Sukhvinder Kalsi-Ryan, PhD University Health Network, Toronto
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT05462925    
Other Study ID Numbers: 19-5395
First Posted: July 18, 2022    Key Record Dates
Last Update Posted: July 25, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data may be shared following study completion upon reasonable request to the investigators and completion of a data sharing agreement.
Time Frame: Once study has been published, the datasets corresponding to the analyses described will be shared upon request.
Access Criteria: Data sharing will require completion of a data sharing agreement. Interested parties should contact the principal investigator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University Health Network, Toronto:
Spinal cord injury
Functional electrical stimulation
Upper limb
Electromyography
Prediction.
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries