RecruitingNot Applicable

Autonomic Effects of Stimulation in SCI

United States20 participantsStarted 2023-07-24

Plain-language summary

This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase power output and heart rate recovery during arm cycle ergometry. In addition, the investigators will see if the stimulation helps regulate body temperature when in a cool environment.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * injury more than 1 year ago, non-ambulatory * level of lesion C3-T6, AIS A, B, or C * stable prescription medication regimen for at least 30 days * must be able to commit to study requirements of 7 visits within a 60-day period Exclusion Criteria: * extensive history of seizures * ventilator dependence or patent tracheostomy site * history of neurologic disorder other than SCI * history of moderate or severe head trauma * contraindications to spine stimulation * significant cardiovascular disease * active psychological disorder * recent history (within 3 months) of substance abuse * open skin lesions over spine at levels targeted for stimulation (L1/L2) and pregnancy

What they're measuring

Power Output

Timeframe: through study completion, up to 2 years

Heart Rate Recovery Time

Timeframe: through study completion, up to 2 years

Total Distance Achieved

Timeframe: through study completion, up to 2 years

Body Core Temperature

Timeframe: through study completion, up to 2 years

Trial details

NCT IDNCT05664646

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2026-07-30

Contact for this trial

Jill Wecht, EdD

(718) 584-9000 jm.wecht@va.gov

View on ClinicalTrials.gov More Spinal Cord Injury trials