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Behavioral Intervention

tSCS paired with arm-crank exercise for Spinal Cord Injury

N/A
Recruiting
Led By Soshi Samejima, DPT, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up repeated measurements before and after each 8 week-intervention block, an average of 6 months
Awards & highlights

Study Summary

This trial aims to test a combination therapy of moderate arm-crank exercise with spinal cord stimulation in adults with chronic spinal cord injury to improve cardiovascular function. Participants will undergo stimulation while exercising on an arm-c

Who is the study for?
Adults aged 21-65 with chronic motor-complete spinal cord injury at or above T6, who are medically stable and cleared for arm bike exercise. Participants must understand English (or have an interpreter), be free of certain health issues like unhealed fractures or infections, and not have cardiopulmonary diseases that would make intense training unsafe.Check my eligibility
What is being tested?
The trial is testing if transcutaneous spinal cord stimulation (tSCS) combined with moderate arm-crank exercise improves cardiovascular function in those with SCI compared to sham stimulation plus exercise. It involves up to 60 visits over six months for exercises and assessments.See study design
What are the potential side effects?
Potential side effects may include discomfort from the stimulation, muscle fatigue from the arm-crank exercise, skin irritation where electrodes are placed, but specific side effects will depend on individual responses to tSCS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~repeated measurements before and after each 8 week-intervention block, an average of 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and repeated measurements before and after each 8 week-intervention block, an average of 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in systolic Blood Pressure (BP) from baseline.
Change in systolic Blood Pressure during a sit-up test or head-up tilt test.
Heart rate variability recorded by electrocardiogram (ECG).
Secondary outcome measures
Autonomic dysfunction following Spinal Cord Injury (ADFSCI) measure
Blood Pressure variability
Change from baseline- Capabilities of Upper Extremity Test
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: tSCS paired with arm-crank exerciseExperimental Treatment2 Interventions
Device: Transcutaneous Spinal Stimulation Non-invasive electrical stimulation of the spinal cord over the skin. Other: Arm-crank exercise Exercise using an arm-bike to target cardiovascular functioning.
Group II: Sham stimulation paired with arm-crank exercisePlacebo Group3 Interventions
Device: Sham Stimulation Non-invasive electrical stimulation of a lower extremity muscle group over the skin. Other: Arm-crank exercise Exercise using an arm-bike to target cardiovascular functioning.

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Who is running the clinical trial?

University of WashingtonLead Sponsor
1,749 Previous Clinical Trials
1,838,628 Total Patients Enrolled
Soshi Samejima, DPT, PhDPrincipal InvestigatorUniversity of Washington
~11 spots leftby Feb 2026
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