NCT05960448 Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury
| NCT ID | NCT05960448 |
| Status | Recruiting |
| Phase | — |
| Sponsor | James J. Peters Veterans Affairs Medical Center |
| Condition | Orthostatic Hypotension |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-07-30 |
| Primary Completion | 2026-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2023-07-30 with a primary completion date of 2026-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this interventional crossover study is to determine the effects of transcutaneous spinal cord stimulation (TSCS) on the ability to perform moderate exercise and regulate core body temperature in the chronic spinal cord injury community. The main questions it aims to answer are: * What are the effects of active TSCS targeted for BP control on exercise endurance time and HR recovery during submaximal arm cycle ergometry (ACE) as compared to sham TSCS in participants with chronic, cervical SCI? * What are the effects of active TSCS on Tcore responses to cool ambient exposure and on subjective reporting of thermal comfort and thermal sensitivity as compared to sham TSCS. Participants will receive sham and active stimulation while using an arm bicycle or while in a cold room. Participants are free to participate in either the exercise phase, the cold room phase, or both phases of this study. Please note that there no expected long term benefits of this study.
Eligibility Criteria
Inclusion Criteria: * You are above the age of 18 years old * You have an SCI between C3-T6 * You have been injured longer than 1 year * You participated in a prior experiment "Targeted Transcutaneous Spinal Cord Stimulation to Restore Autonomic Cardiovascular Health in Individuals with Spinal Cord Injury" * You have an American Spinal Injury Association injury classification scale (AIS) A, B, C * Your prescription medications have not changed for at least 30 days Exclusion Criteria: * You have a history of seizures * You have an acute illness or infection * You have diabetes * You have untreated thyroid disease * You have a neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.) * You have a history of heart or vascular disease (coronary artery disease, congestive heart failure, peripheral artery disease,) * You have a history of moderate or severe head trauma (TBI) or diagnosed with cognitive impairment * You have a present or history of a psychological disorder * You have contraindications to electricity over your spine * You are dependent on a ventilator to breathe or have an open tracheostomy site * You have a recent history of substance abuse (within the past 3 months) * You have open wounds over the spine at the level targeted for stimulation * You are pregnant
Contact & Investigator
Jill M Wecht, EdD
PRINCIPAL INVESTIGATOR
James J. Peters Veterans Affairs Medical Center
Frequently Asked Questions
Who can join the NCT05960448 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Orthostatic Hypotension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05960448 currently recruiting?
Yes, NCT05960448 is actively recruiting participants. Contact the research team at Matthew.Maher@va.gov for enrollment information.
Where is the NCT05960448 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT05960448 clinical trial?
NCT05960448 is sponsored by James J. Peters Veterans Affairs Medical Center. The principal investigator is Jill M Wecht, EdD at James J. Peters Veterans Affairs Medical Center. The trial plans to enroll 20 participants.