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

NCT06000592 | Recruiting DMC FDA Device

• 1 other identifier: 1648740
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

Secondary Outcomes (1)

• The efficacy (#2) of TSCS to improve autonomic control following acute SCI.

  Acute Inpatient Rehabilitation following SCI (up to 4 months)

Study Arms (1)

transcutaneous spinal stimulation

EXPERIMENTAL

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

Interventions

Digitimer DEVICE

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

transcutaneous spinal stimulation

Eligibility Criteria

• Age: 14 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jill M. Wecht, Ed.D.: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

The Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Thomas N Bryce, MD

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

Central Study Contacts

Jorge Chavez, BS

CONTACT

(914)343-0713; jorge.chavez2@mountsinai.org

Jill M Wecht, EdD

CONTACT

(718)584-9000; jm.wecht@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participant awareness during TSCS appears to be unavoidable. The FDA recognizes that some trials of non-pharmacological interventions cannot be fully shammed or blinded, yet with careful blinding of data assessors, it is possible to obtain reliable results that meet FDA approval criteria.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Health Scientist

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: August 21, 2023
• Study Start: January 1, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

US (1)