Transcutaneous spinal cord stimulation for recovery after spinal cord injury

Spinal Cord Stimulation for Autonomic Recovery in Inpatient Rehabilitation After Acute SCI

This study is testing if a new type of spinal cord stimulation can help improve heart function and bladder and bowel control in adults recovering from cervical and upper thoracic spinal cord injuries.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 26 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: University of Washington (Academic / other)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT06540859 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of transcutaneous spinal cord stimulation (tSCS) in improving cardiovascular function and lower urinary tract and bowel functions in adults with cervical and upper thoracic spinal cord injuries during inpatient rehabilitation. The study is randomized, single-blind, and sham-controlled, involving 26 participants aged 21-65 years who are either admitted to or recently discharged from inpatient rehabilitation facilities. Participants will undergo tSCS sessions and be monitored for safety and effectiveness over a three-month period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21-65 with non-progressive spinal cord injuries at or above the T6 level who are currently in or recently discharged from inpatient rehabilitation.

Not a fit: Patients with autoimmune causes of spinal cord dysfunction or those with unhealed fractures or active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance cardiovascular recovery and improve bladder and bowel functions in patients with spinal cord injuries.

How similar studies have performed: While the specific approach of tSCS in this context is novel, similar studies have shown promise in using spinal cord stimulation for various recovery outcomes.

Eligibility criteria

Inclusion Criteria:

1. Are between 21-65 years of age.
2. SCI (non-progressive) at or above the T6 spinal segment.
3. Admitted to inpatient rehabilitation units or discharged from inpatient rehabilitation units but within 4 months since the onset on injury.
4. American Spinal Injury Association Impairment Scale (AIS) A-D for SCI.
5. Have stable medical condition that would permit participation in testing activities.
6. Willing and able to comply with all clinic visits and study-related procedures.
7. Able to understand and complete study-related questionnaires in English.
8. Have no painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
9. Are not currently pregnant or not intending to become pregnant during participation in this study.
10. Are volunteering to be involved in this study.
11. Must provide informed consent.

Exclusion Criteria:

1. Have autoimmune etiology of spinal cord dysfunction/injury
2. Have history of additional neurologic disease, such as stroke, MS, etc.
3. Have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
4. Are ventilator dependent.
5. Have clinically significant, unmanaged, depression, ongoing alcohol and/or drug abuse.
6. 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.
7. Have Intrathecal baclofen pump.
8. Have cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
9. 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, pressure sores, or unstable diabetes.
10. 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.
11. Are a member of the investigational team or his/her immediate family.
12. Have history of severe allergy (i.e. allergic reaction that could not be treated with antihistaminic medication)
13. Have malabsorption syndrome, primary hyperthyroidism, and/or hypogonadism.
14. Have a history of seizures.

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; Inpatient Rehabilitation; Cardiovascular Recovery following SCI; Bladder and Bowel Recovery following SCI