Recruiting

TSCS

Sponsor:

Jill M. Wecht, Ed.D.

Code:

NCT06000592

Conditions

Acute Spinal Cord Injury

Spinal Cord Injuries

Neuromodulation

Traumatic Spinal Cord Injury

Spinal Cord Stimulation

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Not accepted

Interventions

Digitimer

Study Details

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

Study ID

NCT06000592

Start date

Jan 1, 2022

Status verified date

Apr, 2024

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Digitimer

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

Primary outcome measure

  • The efficacy (#1) of TSCS to improve autonomic control following acute SCI. [ Time Frame: Acute Inpatient Rehabilitation following SCI (up to 4 months) ]
  • The safety (#1) of TSCS to improve autonomic control following acute SCI. [ Time Frame: Acute Inpatient Rehabilitation following SCI (up to 4 months) ]
  • The safety (#2) of TSCS to improve autonomic control following acute SCI. [ Time Frame: Acute Inpatient Rehabilitation following SCI (up to 4 months) ]

Central Contacts and Locations

Central contacts

Jorge Chavez, BS

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

Jill M Wecht, EdD

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

Locations

The Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Miguel Escalón, MD, MPH

212-241-6321miguel.escalon@mountsinai.org

More Information

Sponsor

Jill M. Wecht, Ed.D.

Last update posted

Apr 2, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jill M. Wecht, Ed.D. on 2024-04-02.