Actively Recruiting
Transcutaneous Spinal Cord Stimulation Combined With Arm Bike for Cardiovascular Recovery in SCI
Led by University of Washington · Updated on 2026-05-06
16
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Spinal cord injury (SCI) can make it hard for the body to self-regulate some of its automatic functions like blood pressure, breathing, and heart rate. This can also make it hard for those living with SCI to exercise or complete their usual daily activities. The goal of this randomized trial is to test combinatory therapy of moderate arm-crank exercise paired with non-invasive transcutaneous spinal cord stimulation (tSCS) for cardiovascular recovery in adults aged 21-65 following chronic motor-complete spinal cord injury (SCI) at or above the thoracic sixth spinal segment (≥T6). The main questions the study aims to answer are: * Conduct tSCS mapping to determine the most effective location and stimulation intensity for BP control in individuals with motor-complete SCI ≥ T6. * Evaluate the effects 8 weeks of targeted tSCS paired with arm-crank exercise compared to sham stimulation with exercise on improving cardiovascular function in individuals with motor-complete SCI ≥T6. * Evaluate the dosage-response of 8 weeks vs. 16 weeks of targeted tSCS paired with arm-crank exercise on cardiovascular function in individuals with motor-complete SCI ≥T6. * Explore the mechanisms involved in cardiovascular recovery with long-term tSCS paired with arm-crank exercise. Participants will: * Receive either transcutaneous spinal cord stimulation or "sham" spinal cord stimulation while exercising on an arm-crank bicycle in the first 8 weeks. * Come in for approximately 60 visits over a 6-month period. This includes 2, 8-week periods where the investigators will ask participants to come in 3x per week for spinal cord stimulation and exercise. * During assessment visits the researchers will perform a variety of exams including a neurologic, cardiovascular, pulmonary, physical, and autonomic exam, and will ask questions about quality of life and functioning. Assessment procedures also include stool sample and nasal swab collection. Researchers will compare those who receive tSCS and do moderate arm-crank exercise to those who receive a sham stimulation and do moderate arm-crank exercise to see if tSCS is effective at improving cardiovascular and autonomic functioning in those with SCI.
CONDITIONS
Official Title
Transcutaneous Spinal Cord Stimulation Combined With Arm Bike for Cardiovascular Recovery in SCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 21 and 65 years of age
- Chronic motor-complete spinal cord injury at or above T6
- More than 10 months post injury or diagnosis and at least 6 months from any spinal surgery
- American Spinal Injury Association Impairment Scale (AIS) grade A or B for SCI
- Stable medical condition without cardiopulmonary disease that prevents intensive training or testing
- Cleared for strenuous arm-crank exercise by primary physician
- Willing and able to attend all clinic visits and study procedures
- Able to understand and complete study questionnaires in English or with an interpreter
- No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection interfering with testing
- Stable management of spinal cord-related clinical issues like spasticity
- Women of childbearing potential must not be pregnant, lactating, or intending pregnancy and agree to use contraception during and 28 days after treatment
- Sexually active males with female partners of childbearing potential must agree to use contraception during and 28 days after treatment
- Volunteering to participate
- Have adequate social support to attend up to 3 training and assessment sessions per week for up to 6 months
- Must provide informed consent
You will not qualify if you...
- Autoimmune causes of spinal cord dysfunction or injury
- History of other neurologic diseases such as stroke, multiple sclerosis, or traumatic brain injury
- Peripheral neuropathy like diabetic polyneuropathy or entrapment neuropathy
- Rheumatic diseases including rheumatoid arthritis or systemic lupus erythematosus
- Ventilator dependence
- Clinically significant unmanaged depression, ongoing alcohol or drug abuse
- Use of medication or treatments judged unsafe by investigators
- Presence of intrathecal baclofen pump
- Cardiovascular, respiratory, bladder, or kidney disease unrelated to SCI, including hydronephrosis or obstructive kidney stones
- Severe acute medical issues affecting participation such as active infections, heterotopic ossification, new antidepressant use, severe muscle pain, pressure sores, or unstable diabetes
- Presence of pacemakers, stimulators, medication pumps in the trunk, deep brain stimulators, metallic devices in the head, or vagus nerve stimulators
- Taking more than 40 mg of Baclofen per day
- Severe anemia or hypovolemia within last six months
- Being a member of the investigational team or immediate family
- Prior electrode implantation surgery
- Signs of lower motor neuron impairment
- History of severe allergies unresponsive to antihistamines
- Malabsorption syndrome, primary hyperthyroidism, or hypogonadism
- History of seizures
- Chronic headaches or migraines
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
S
Soshi Samejima, DPT, PhD
CONTACT
K
Katie Singsank
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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