Spinal Cord Stimulation + Arm Bike 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

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ repeated measurements before and after each 8 week-intervention block, an average of 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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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