Status:
RECRUITING
Spinal Cord Stimulation for Autonomic Recovery in Inpatient Rehabilitation After Acute SCI
Lead Sponsor:
University of Washington
Collaborating Sponsors:
The Craig H. Neilsen Foundation
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
This study is a randomized, single-blind, two-arm sham-controlled clinical trial to evaluate the safety and efficacy of transcutaneous spinal cord stimulation (tSCS) over the lower thoracic and upper ...
Eligibility Criteria
Inclusion
- Are between 21-65 years of age.
- SCI (non-progressive) at or above the T6 spinal segment.
- Admitted to inpatient rehabilitation units or discharged from inpatient rehabilitation units but within 4 months since the onset on injury.
- American Spinal Injury Association Impairment Scale (AIS) A-D for SCI.
- Have stable medical condition that would permit participation in testing activities.
- Willing and able to comply with all clinic visits and study-related procedures.
- Able to understand and complete study-related questionnaires in English.
- Have no painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
- Are not currently pregnant or not intending to become pregnant during participation in this study.
- Are volunteering to be involved in this study.
- Must provide informed consent.
Exclusion
- Have autoimmune etiology of spinal cord dysfunction/injury
- Have history of additional neurologic disease, such as stroke, MS, 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, 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.
- Are a member of the investigational team or his/her immediate family.
- 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.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06540859
Start Date
December 1 2024
End Date
October 1 2027
Last Update
March 27 2025
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195