Transcutaneous spinal stimulation to improve blood pressure after a recent spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.