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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Pressure; Spinal Cord Injuries; SCI - Spinal Cord Injury; Blood Pressure Disorders; Traumatic Spinal Cord Injury; Acute Spinal Cord Injury; Neuromodulation; Spinal Cord Stimulation
• Intervention / Treatment: Device: Digitimer

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jorge Chavez, BS; Phone Number: (914)343-0713; Email: jorge.chavez2@mountsinai.org
• Study Contact Backup: Name: Jill M Wecht, EdD; Phone Number: 3122 (718)584-9000; Email: jm.wecht@va.gov

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • The Icahn School of Medicine at Mount Sinai
      • Contact: Miguel Escalón, MD, MPH; Phone Number: 212-241-6321; Email: miguel.escalon@mountsinai.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Digitimer; transcutaneous spinal cord stimulation for blood pressure control following spinal cord injury.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Jill M. Wecht, Ed.D.
• Collaborators: Icahn School of Medicine at Mount Sinai
• Investigators: Study Director: Thomas N Bryce, MD, Icahn School Of Medicine At Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 23, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 1648740 (Other Identifier: James J. VA Medical Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes