Transcutaneous spinal stimulation to stabilize blood pressure after 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

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.

Why it matters

Who can join: the full rules

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 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.