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Behavioural Intervention

Therapy + Stimulation for Spinal Cord Injury (ABT-TCSCS Trial)

N/A
Recruiting
Led By Sukhvinder Kalsi-Ryan
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
At least 6 months post-spinal cord injury
Individuals with chronic traumatic and non-traumatic cervical SCI (ASIA classification A-incomplete, B, C, D) between C1-C8
Must not have
Individuals with any other upper extremity deficit
Unable to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 4 weeks (12 sessions) of abt, and after 7 weeks (28 sessions) of abt-tcscs
Awards & highlights

Summary

"This trial is looking at whether a combination of activity-based therapy and spinal cord stimulation can help improve arm and hand recovery in individuals with cervical spinal cord injury."

Who is the study for?
This trial is for individuals with a cervical spinal cord injury who are looking to improve their arm and hand functions. Specific eligibility details aren't provided, but typically participants must meet certain health conditions.
What is being tested?
The study explores the effectiveness of combining activity-based therapy with transcutaneous spinal cord stimulation to enhance recovery of arm and hand movements after a cervical spinal cord injury.
What are the potential side effects?
Potential side effects are not detailed in the information provided, but such therapies may include skin irritation at the stimulation site or muscle fatigue from therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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It has been over 6 months since my spinal cord injury.
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I have a spinal cord injury between C1-C8 with some level of impairment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a problem with my arm or hand.
Select...
I am unable to understand or sign the consent form.
Select...
I cannot join an intensive outpatient rehab program.
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My elbow or wrist is very stiff, limiting its movement by more than half.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 4 weeks (12 sessions) of abt, and after 7 weeks (28 sessions) of abt-tcscs
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 4 weeks (12 sessions) of abt, and after 7 weeks (28 sessions) of abt-tcscs for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Version 1
International Standards of Neurological Classification of SCI (ISNCSCI)
Spinal Cord Independence Measure (SCIM)
+2 more
Secondary study objectives
Neurophysiological Assessment using surface electromyography (EMG)

Trial Design

1Treatment groups
Experimental Treatment
Group I: ABT-TCSCSExperimental Treatment1 Intervention
The participants will receive activity-based therapy combined with transcutaneous spinal cord stimulation.

Find a Location

Who is running the clinical trial?

Ontario Neurotrauma FoundationOTHER
23 Previous Clinical Trials
1,103 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,514 Previous Clinical Trials
500,181 Total Patients Enrolled
Sukhvinder Kalsi-RyanPrincipal InvestigatorToronto Rehabilitation Institute
~13 spots leftby Dec 2026
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