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

NCT ID: NCT06000592

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2026-10-01

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

transcutaneous spinal stimulation

Transcutaneous spinal cord stimulation (TSCS) protocol to stabilize seated systolic blood pressure in newly injured patients with spinal cord injury and to test the ability of TSCS to reduce the fall in blood pressure when these patients are moved from the supine to the seated position.

Group Type: EXPERIMENTAL

Digitimer

Intervention Type: DEVICE

transcutaneous spinal cord stimulation for blood pressure control following spinal cord injury.

Interventions

Digitimer

transcutaneous spinal cord stimulation for blood pressure control following spinal cord injury.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

Jill M. Wecht, Ed.D.

FED

Sponsor Role: lead

Responsible Party

Jill M. Wecht, Ed.D.

Research Health Scientist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thomas N Bryce, MD

Role: STUDY_DIRECTOR

Icahn School of Medicine at Mount Sinai

Locations

The Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jorge Chavez, BS

Role: CONTACT

jorge.chavez2@mountsinai.org

(914)343-0713

Jill M Wecht, EdD

Role: CONTACT

jm.wecht@va.gov

(718)584-9000 ext. 3122

Facility Contacts

Miguel Escalón, MD, MPH

Role: primary

miguel.escalon@mountsinai.org

212-241-6321

Other Identifiers

1648740

Identifier Type: -

Identifier Source: org_study_id