Transcutaneous Spinal Cord Stimulation and Arm Bike for Cardiovascular Recovery in Spinal Cord Injury
This study is looking at ways to help people with chronic spinal cord injuries (SCI) manage their blood pressure and heart rate. It combines two treatments: non-invasive Transcutaneous Spinal Cord Stimulation (tSCS), which uses electrical stimulation over the skin, and arm-crank bike exercise. The goal is to see if this combination can improve cardiovascular health in adults aged 21-65 who have had a complete motor SCI at or above the T6 level for at least 10 months. The study will measure changes in your systolic blood pressure and heart rate variability to see if the treatments are effective. The study is currently unclear on its recruitment status and plans to enroll 16 participants.
- Study design
- This is an interventional, randomized trial planning to enroll 16 participants. It will test two interventions: Transcutaneous Spinal Cord Stimulation and arm-crank bike exercise.
- What's involved
- You would participate in repeated measurements before and after each 8-week intervention block, for an average of 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Measurements will be taken for an average of 6 months after the intervention blocks.
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NCT06313515
Transcutaneous Spinal Cord Stimulation Combined With Arm Bike for Cardiovascular Recovery in SCI
Recruiting
NAAges 21–65InterventionalTreatmentUniversity of WashingtonInvestigator-initiated
~16 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Transcutaneous Spinal Cord StimulationArm-crank bike exerciseSham Stimulation
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in systolic Blood Pressure (BP) from baseline.
Measured over Baseline
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesWashington1
Study leadership
- Soshi Samejima, DPT, PhD · PRINCIPAL_INVESTIGATOR · University of Washington
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Are between 21-65 years of age.
Chronic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal cord segment.
Greater than ten months post injury or diagnosis, at least 6 months from any spinal surgery.
American Spinal Injury Association Impairment Scale (AIS) A, B for SCI.
Have stable medical condition without cardiopulmonary disease that would contraindicate participation in intensive training or testing activities.
Cleared for strenuous exercise with arm bike by a primary physician of the subject (the clearance for intensive training with arm bike is obtained verbally or through a written form by a primary physician.)
Willing and able to comply with all clinic visits and study-related procedures.
Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
Have no painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
Are with stable management of spinal cord related clinical issues (i.e., spasticity management).
Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
Women of childbearing potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.
Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.
Are volunteering to be involved in this study.
Has adequate social support to be able to participate in training and assessment sessions, up to 3 sessions per week, for the duration of up to 6 months within the study period.
Must provide informed consent.
Exclusion
Have autoimmune etiology of spinal cord dysfunction/injury
Have history of additional neurologic disease, such as stroke, MS, traumatic brain injury, etc.
Have peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
Have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
Are ventilator dependent.
Have clinically significant, unmanaged, depression, ongoing alcohol and/or drug abuse.
Use any medication or treatment that in the opinion of the investigators indicates that it is not in the best interest of the participant to participate in this study.
Have Intrathecal baclofen pump.
Have cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
Have severe acute medical issue that in the investigators' judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to acute urinary tract infections, active heterotopic ossification, newly changed antidepressant medications \[tricyclics\], debilitating muscle pain, pressure sores, or unstable diabetes.
Have pacemakers, stimulators, medication pumps in the trunk, deep brain stimulators, metallic devices in the head such as aneurysm clips/coils and stents, vagus nerve stimulators.
Take more than 40 mg of Baclofen per day
Have severe anemia (Hgb\<8 g/dl or Hgb,80 g/L) or hypovolemia as measured by hematocrit via blood test in the last six months.
Are a member of the investigational team or his/her immediate family.
Have undergone electrode implantation surgery.
Have signs of lower motor neuron impairment (i.e., concomitant conus medullaris/cauda equina injury).
Have history of severe allergy (i.e. allergic reaction that could not be treated with antihistaminic medication)
Have malabsorption syndrome, primary hyperthyroidism, and/or hypogonadism.
Have a history of seizures.
Have chronic headaches or migraines.
What this trial measures
- Change in systolic Blood Pressure (BP) from baseline.Baseline
Continuous beat-by-beat BP will be measured using a finger photoplethysmography.
- Change in systolic Blood Pressure during a sit-up test or head-up tilt test.Repeated measurements before and after each 8 week-intervention block, an average of 6 months
Continuous beat-by-beat BP will be measured during a orthostatic challenge.
- Heart rate variability recorded by electrocardiogram (ECG).Repeated measurements before and after each 8 week-intervention block, an average of 6 months
Parameters using RR intervals (R-wave peak to R-wave peak in electrocardiogram) processed to assess the activity of autonomic nervous system.