Transcutaneous spinal stimulation to improve blood pressure after a recent spinal cord injury
Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Individuals With an Acute Spinal Cord Injury - A Safety, Feasibility and Efficacy Study
We will try a noninvasive spinal stimulation to see if it raises and steadies blood pressure in people 7–30 days after a thoracic spinal cord injury who have low blood pressure or dizziness when sitting up.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT05731986 on ClinicalTrials.gov |
What this trial studies
This interventional study uses transcutaneous spinal cord stimulation (scTS) in people early after spinal cord injury during their inpatient rehabilitation to determine effects on blood pressure during an orthostatic provocation (sit-up) test. Participants undergo mapping to identify stimulation sites and parameters, followed by 'optimal' stimulation and a sham (placebo-like) stimulation for comparison. The primary focus is whether scTS can raise systolic blood pressure into the normal target range (around 110–120 mmHg) and relieve orthostatic symptoms such as dizziness and nausea. The trial enrolls individuals 7–30 days post-injury with thoracic-level injuries and documented orthostatic hypotension or related symptoms.
Who should consider this trial
Good fit: Ideal candidates are people 7–30 days after a thoracic (≥T2) spinal cord injury with AIS A–C who have baseline hypotension, a ≥20 mmHg drop in systolic BP on sitting, or symptoms of orthostasis.
Not a fit: Patients who are outside the 7–30 day window, have cervical injuries above T2, are ventilator-dependent, have implanted pacemakers/defibrillators or stimulators, significant cardiac disease, recent DVT/PE, or other exclusionary illnesses are unlikely to benefit or are not eligible.
Why it matters
Potential benefit: If successful, this approach could reduce orthostatic hypotension, improve tolerance for rehabilitation activities, and lower short- and long-term cardiovascular complications.
How similar studies have performed: Small prior studies using epidural or transcutaneous spinal stimulation in people with chronic (>1 year) spinal cord injury have shown promising blood pressure stabilization, but this approach has not been tested in the acute 7–30 day population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 7-30 days after injury * Injury level ≥T2 (thoracic level) * American Spinal Injury Association Impairment Scale (AIS) A-C * Exhibits at least one of the following hypotensive symptoms: 1. Baseline hypotension - resting supine or seated 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 (e.g., a recent diagnosis of a deep vein thrombosis (DVT) or pulmonary embolism (PE), a pressure injury that might interfere with the intervention, etc.) or infection * 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 * Initiated on new cardiac medications within the past 5 days * 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.