Prediction of Muscle Responsiveness to FES Therapy

NCT ID: NCT05462925

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-20
• Study Completion Date: 2024-12-31

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.

Conditions

Spinal Cord Injury Cervical

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Functional electrical stimulation therapy.

Intervention Type: DEVICE

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

Interventions

Functional electrical stimulation therapy.

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wings for Life

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José Zariffa, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Sukhvinder Kalsi-Ryan, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Toronto Rehabilitation Institute - University Health Network

Toronto, Ontario, Canada

Countries

Canada

References

Balbinot G, Li G, Chen A, Eftekhar P, Ma W, Kalsi-Ryan S, Zariffa J. Upper Extremity Muscle Recovery Profiles With Functional Electrical Stimulation Therapy in Chronic Spinal Cord Injury. Neuromodulation. 2025 Oct 16:S1094-7159(25)01026-8. doi: 10.1016/j.neurom.2025.08.416. Online ahead of print.

Reference Type: DERIVED

PMID: 41099684 (View on PubMed)

Other Identifiers

19-5395

Identifier Type: -

Identifier Source: org_study_id