NCT05725499 The Effect of Transcutaneous Stimulation on Blood Pressure in Spinal Cord Injury (SCI)
| NCT ID | NCT05725499 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kessler Foundation |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2026-08-01 |
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 5 participants in total. It began in 2023-02-01 with a primary completion date of 2026-08-01.
⚠ 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
This project will investigate the effect of spinal cord transcutaneous stimulation on blood pressure in individuals with a chronic spinal cord injury who experience blood pressure instability, specifically, orthostatic hypotension (a drop in blood pressure when moving from lying flat on your back to an upright position). The main questions it aims to answer are: 1. What are the various spinal sites and stimulation parameters that normalize and stabilize blood pressure during an orthostatic provocation (70 degrees tilt)? 2. Does training, i.e., exposure to repeated stimulation sessions, have an effect on blood pressure stability? Participants will undergo orthostatic tests (lying on a table that starts out flat, then tilts upward up to 70 degrees), with and without stimulation, and changes in their blood pressure will be evaluated.
Eligibility Criteria
Inclusion Criteria: * Spinal cord injury for greater than or equal to 6 months * Injury level ≥ T6 (thoracic level) * American Spinal Injury Association (ASIA) Impairment Scale (AIS) A-D * Exhibits at least one of the following hypotensive symptoms: 1. Baseline hypotension - resting supine or seated systolic blood pressure(SBP) \< 90mmHg; 2. SBP drop ≥ 20 mmHg within 5 minutes of assuming seated position; 3. Symptoms of orthostasis with a drop of SBP (\<90mmHg) from supine to sitting Exclusion Criteria: * Current illness (infection, a pressure injury that might interfere with the intervention, a recent diagnosis of DVT/PE, etc.) * Ventilator-dependent * History of implanted brain/spine/nerve stimulators * Cardiac pacemaker/defibrillator or intra-cardiac lines * Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction * Insufficient mental capacity to understand and independently provide consent * Pregnancy * Cancer * Deemed unsuitable by study physician
Contact & Investigator
Gail F Forrest, Phd
PRINCIPAL INVESTIGATOR
Kessler Foundation
Frequently Asked Questions
Who can join the NCT05725499 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05725499 currently recruiting?
Yes, NCT05725499 is actively recruiting participants. Contact the research team at lmartinez@kesslerfoundation.org for enrollment information.
Where is the NCT05725499 trial being conducted?
This trial is being conducted at West Orange, United States.
Who is sponsoring the NCT05725499 clinical trial?
NCT05725499 is sponsored by Kessler Foundation. The principal investigator is Gail F Forrest, Phd at Kessler Foundation. The trial plans to enroll 5 participants.