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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06000592
Other study ID # 1648740
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date October 1, 2026

Study information

Verified date April 2024
Source James J. Peters Veterans Affairs Medical Center
Contact Jorge Chavez, BS
Phone (914)343-0713
Email jorge.chavez2@mountsinai.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Current forms of pharmacologic and non-pharmacologic treatments for hypotension and orthostatic hypotension (OH) remain inadequate during acute inpatient rehabilitation (AIR) following a traumatic spinal cord injury (SCI). A critical need exists for the identification of safe, practical, and effective treatment options that stabilize blood pressure (BP) after traumatic SCI. Recent published evidence suggests that transcutaneous Spinal Cord Stimulation (TSCS) can be used to raise seated BP, and mitigate the falls in BP during orthostatic repositioning in individuals with chronic SCI. This site-specific project will focus on the use of TSCS to stabilizing seated BP and mitigate the fall in BP during orthostatic repositioning during AIR following traumatic SCI.


Description:

Based on available evidence, TSCS may have advantages over current pharmacological approaches to the treatment of hypotension and OH: (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 fewer risk. We are asking several key questions: (1) what are the effects of TSCS on seated BP and BP changes during an orthostatic challenge, (2) is the application of TSCS during AIR tolerable based on pain reporting, (3) is there evidence of superficial burns to the skin near the site of cathode or anode placement, and (4) are the symptoms of orthostatic intolerance reduced with TSCS? 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 SCI population, thereby overcoming barriers to engagement in prescribed AIR regimens that are imposed by autonomic nervous system dysfunction.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date October 1, 2026
Est. primary completion date August 31, 2026
Accepts healthy volunteers No
Gender All
Age group 14 Years to 100 Years
Eligibility 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

Study Design


Intervention

Device:
Digitimer
transcutaneous spinal cord stimulation for blood pressure control following spinal cord injury.

Locations

Country Name City State
United States The Icahn School of Medicine at Mount Sinai New York New York

Sponsors (2)

Lead Sponsor Collaborator
Jill M. Wecht, Ed.D. Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
Secondary 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)
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