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FES Therapy + Task-Specific Training for Spinal Cord Injury

N/A
Waitlist Available
Led By Julio Furlan
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Other neurological diseases (i.e. peripheral neuropathies)
Contraindications for neurophysiological tests
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in baseline ntf-3 at 3 & 6 months
Awards & highlights

Summary

This trial will test whether earlier delivery of FEST+TST after SCI leads to better functional and neurological recovery compared to later delivery.

Who is the study for?
This trial is for individuals in the early stages (less than 3 months) after a traumatic spinal cord injury at the neck level that still allows for some movement. It's not suitable for those with other medical conditions affecting treatment, neurological diseases, severe mental illness, learning disabilities, recent substance abuse, MRI contraindications, or sensory deficits impacting tests.
What is being tested?
The study examines if the timing of functional electrical stimulation therapy combined with task-specific training (FEST+TST) affects recovery of function and nerve health following a cervical spinal cord injury.
What are the potential side effects?
While specific side effects are not listed here, FES Therapy can sometimes cause muscle fatigue or skin irritation under electrode sites. Task-specific training may lead to general tiredness or muscle soreness.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a neurological condition like peripheral neuropathy.
Select...
I cannot undergo certain nerve function tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in baseline neuromuscular junction transmission at 3 & 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in baseline neuromuscular junction transmission at 3 & 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ASIA Upper-Extremity Sensory Score (UESS)
American Spinal Injury Association (ASIA) Upper-Extremity Motor Score (UEMS)
Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP)
+1 more
Secondary study objectives
F-Wave
Functional Magnetic Resonance Imaging (fMRI)
H-Reflex
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Early FEST + TSTExperimental Treatment1 Intervention
Participants will receive FEST+TST at 3 to 6 months from SCI onset.
Group II: Delayed FEST + TSTExperimental Treatment1 Intervention
Participants will receive FEST+TST at 6 to 9 months from SCI onset.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,514 Previous Clinical Trials
500,187 Total Patients Enrolled
Julio FurlanPrincipal InvestigatorKITE, Toronto Rehab-University Health Network
Julio Furlan, MD, PhDPrincipal InvestigatorKITE, Toronto Rehab-University Health Network

Media Library

FEST+TST (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04910204 — N/A
Spinal Cord Injury Research Study Groups: Delayed FEST + TST, Early FEST + TST
Spinal Cord Injury Clinical Trial 2023: FEST+TST Highlights & Side Effects. Trial Name: NCT04910204 — N/A
FEST+TST (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04910204 — N/A
~12 spots leftby Dec 2026
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