Prediction of Muscle Responsiveness to FES Therapy

Spinal Cord Injury Cervical Clinical Trial

Official title:

Point-of-care Prediction of Muscle Responsiveness to Functional Electrical Stimulation Therapy During Neurorehabilitation (Sub-study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05462925
• Other study ID #: 19-5395
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 20, 2022
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury Cervical

Intervention

Device:
• Functional electrical stimulation therapy.
Functional electrical stimulation therapy will be delivered using the MyndMove system (MyndTec, Inc., Mississauga, Canada).

Locations

Country	Name	City	State
Canada	Toronto Rehabilitation Institute - University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Wings for Life

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength recovery profile	Change over time in manual muscle testing conducted on each treated muscle.	Muscle strength assessed at each of 30 therapy sessions (3-5 sessions per week).
Secondary	Surface electromyography signal features	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.	Baseline (required). End of therapy (6-10 weeks; optional).