TSCS for Acute SCI

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorIcahn School of Medicine at Mount Sinai

About this trial

This project will focus on a novel approach to stabilizing blood pressure (BP) during inpatient rehabilitation after acute SCI. After SCI, people have unstable blood pressure, ranging from too low (orthostatic hypotension) to too high (autonomic dysreflexia). Unstable BP often interferes with performing effective physical rehabilitation after SCI. A critical need exists for the identification of safe, practical and effective treatment options that stabilize BP after traumatic SCI. Transcutaneous Spinal Cord Stimulation (TSCS) has several advantages over pharmacological approaches: (1) does not exacerbate polypharmacy, (2) can be activated/deactivated rapidly, and (3) can be applied in synergy with physical exercise. The study team is asking the key question: "What if applying TSCS earlier after injury could prevent the development of BP instability?" To facilitate adoption of TSCS for widespread clinical use, the study team plans to map and develop a parameter configuration that will result in an easy to follow algorithm to maximize individual benefits, while minimizing the burden on healthcare professionals. This project will provide the foundational evidence to support the feasible and safe application of TSCS in the newly injured population, thereby overcoming barriers to engagement in prescribed inpatient rehabilitation regimens that are imposed by BP instability.

Eligibility criteria

Qualifiers

All newly injured patients with SCI who are sequentially admitted during the 42-month recruitment period

Meet the following Model Systems entry criteria with evidence of BP instability

Exhibit one or more of the following: Resting hypotension - systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females; OH - fall in systolic BP ≥ 20 mmHg and/or a fall in diastolic BP ≥ 10 mmHg within 10 minutes of assuming an upright position; BP instability - fluctuation in systolic BP ≥ 20 mmHg and/or fluctuation in diastolic BP ≥ 10 mmHg within a single day during routine activities in the AIR setting.

Have trouble with your blood pressure as determined by your doctor.

Disqualifiers

Implanted brain/spine/nerve stimulators, cochlear implants, cardiac pacemaker/defibrillator, or intracardiac lines

Open skin lesions on or near the electrode placement sites (neck, upper back)

Significant coronary artery or cardiac conduction disease

Recent history of myocardial infarction

Trial design

Treatments tested in this trial

  • TSCS Mapping
  • Transcutaneous spinal cord stimulation

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Icahn School of Medicine at Mount Sinai

Lead sponsor

James J. Peters Veterans Affairs Medical Center

Collaborator