Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI

Study Overview
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Brief Summary
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This site-specific project will focus on a novel non-pharmacologic approach to stabilizing BP during AIR after acute traumatic SCI. Current forms of pharmacologic and non-pharmacologic treatments for hypotension and OH remain inadequate in the SCI population. 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: (1) does not exacerbate polypharmacy, (2) can be activated/deactivated rapidly, and (3) can be applied in synergy with physical exercise. TSCS represents an alternate approach to epidural SCS, with far greater potential to reach large numbers of individuals, thus providing for a greater likelihood of clinical implementation with far fewer risks. We are asking the key question: what if applying SCS earlier after injury could prevent the development of BP instability? To facilitate adoption of TSCS for widespread clinical use, we have designed a spatial-temporal mapping and parameter configuration approach that will result in a key deliverable for SCI care: a standard, easy to follow algorithm that will maximize individual benefits of spinal neuromodulation, while minimizing the burden on healthcare professionals. This project will provide the foundational evidence to support the feasible and safe application of TSCS for widespread clinical utility in the newly injured population, thereby overcoming barriers to engagement in prescribed AIR regimens that are imposed by ANS dysfunction.

Official Title
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Safety, Feasibility, and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients With Spinal Cord Injury

Conditions
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Acute Spinal Cord Injury, Spinal Cord Injuries, Neuromodulation, Traumatic Spinal Cord Injury, Spinal Cord Stimulation, SCI - Spinal Cord Injury, Blood Pressure, Blood Pressure Disorders

Intervention / Treatment
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* Device: Digitimer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly injured patients with traumatic SCI Admitted to Acute Inpatient Rehabilitation at Mount Sinai Within one year of SCI Seated hypotension (systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females) Orthostatic hypotension (fall in systolic BP ≥ 20 mmHg and/or a fall in diastolic BP ≥ 10 mmHg within 10 minutes of assuming an upright position) Daily fluctuation in systolic BP ≥ 20 mmHg and/or fluctuation in diastolic BP ≥ 10 mmHg At least 14 years old Exclusion Criteria: 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 Insufficient mental capacity to understand and independently provide consent Pregnancy Cancer Deemed unsuitable by study physician

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transcutaneous spinal stimulation<br> | Device: Digitimer<br>* transcutaneous spinal cord stimulation for blood pressure control following spinal cord injury.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety (#1) of TSCS to improve autonomic control following acute SCI. | Assess pain levels using a Likert Scale 0-10 (0=no pain, 10=worst pain). | Acute Inpatient Rehabilitation following SCI (up to 4 months) | 
| The safety (#2) of TSCS to improve autonomic control following acute SCI. | Document any skin changes (burns) following use of TSCS in count of occurrences. | Acute Inpatient Rehabilitation following SCI (up to 4 months) | 
| The efficacy (#1) of TSCS to improve autonomic control following acute SCI. | Blood pressure changes (mmHg) during the sit-up test with TSCS compared to no stimulation. | Acute Inpatient Rehabilitation following SCI (up to 4 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy (#2) of TSCS to improve autonomic control following acute SCI. | To compare dizziness symptoms on a Likert Scale 0-10 (0=no dizziness, 10=worst dizziness) during the sit-up test with TSCS compared to no stimulation.. | Acute Inpatient Rehabilitation following SCI (up to 4 months) |