Combining spinal cord stimulation with arm exercise for heart recovery in spinal cord injury patients

Transcutaneous Spinal Cord Stimulation Combined With Arm Crank Exercise for Cardiovascular Recovery in Cervical and Upper Thoracic SCI

This study is testing if combining a special spinal cord stimulation with arm exercises can help improve heart health in adults with serious spinal cord injuries.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: University of Washington (other)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT06313515 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of combining transcutaneous spinal cord stimulation (tSCS) with arm-crank exercise to improve cardiovascular recovery in adults aged 21-65 who have chronic motor-complete spinal cord injuries at or above the T6 level. Participants will undergo a randomized trial where some will receive active tSCS while others will receive sham stimulation, both paired with arm-bike exercise. The study aims to identify the optimal stimulation parameters for blood pressure control and assess the overall impact on cardiovascular function over an 8-week period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21-65 with chronic motor-complete spinal cord injuries at or above the T6 level.

Not a fit: Patients with incomplete spinal cord injuries or those with significant cardiopulmonary conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance cardiovascular health and exercise capacity in individuals with spinal cord injuries.

How similar studies have performed: While the combination of tSCS and exercise is a novel approach, similar studies have shown promise in improving outcomes for patients with spinal cord injuries.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Seattle, Washington

• University of Washington — Seattle, Washington, United States (RECRUITING)

Study contacts

• Principal investigator: Soshi Samejima, DPT, PhD — University of Washington
• Study coordinator: Soshi Samejima, DPT, PhD

Conditions: Spinal Cord Injuries, Transcutaneous Spinal Cord Stimulation, Arm-Bike Exercise, Cardiovascular Function