Transcutaneous spinal stimulation to stabilize blood pressure after spinal cord injury
Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Chronic Spinal Cord Injury
This will test whether noninvasive transcutaneous spinal cord stimulation can raise and stabilize blood pressure in people with chronic high-level spinal cord injuries who experience orthostatic hypotension.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT05725499 on ClinicalTrials.gov |
What this trial studies
Researchers will apply transcutaneous spinal cord stimulation at various thoracic sites and with different stimulation settings while participants undergo controlled tilt-table tests to 70 degrees. Blood pressure responses will be compared with and without stimulation to determine which sites and parameters best prevent drops in blood pressure on upright posture. The protocol also includes repeated stimulation sessions to see whether repeated exposure (training) improves blood pressure stability over time. Participants are adults with chronic spinal cord injury at or above T6 who have documented orthostatic hypotension or related symptoms.
Who should consider this trial
Good fit: Ideal candidates are people at least six months post-spinal cord injury at T6 or above (ASIA A–D) who experience baseline hypotension or clinically significant drops in systolic blood pressure with position changes.
Not a fit: People with implanted stimulators or pacemakers, significant cardiac conduction disease, ventilator dependence, active serious illness, pregnancy, or those without orthostatic hypotension are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could offer a noninvasive way to reduce dizziness, fainting, and long-term cardiovascular risk by preventing drops in blood pressure after spinal cord injury.
How similar studies have performed: Epidural spinal stimulation has shown promising results for cardiovascular control and one small report of transcutaneous stimulation restored cardiovascular function, but broader evidence for scTS is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
West Orange, New Jersey
- Kessler Foundation — West Orange, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Gail F Forrest, Phd — Kessler Foundation
- Study coordinator: LeighAnn Martinez, BA
- Email: lmartinez@kesslerfoundation.org
- Phone: (973)324-3557
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.