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Transcutaneous Spinal Cord Stimulation for Blood Pressure Control After Spinal Cord Injury

This study is looking at a treatment called transcutaneous spinal cord stimulation (TSCS) using a Digitimer device. This device delivers gentle electrical pulses through the skin to the spinal cord. The goal is to see if TSCS can help stabilize blood pressure in people who have recently had a traumatic spinal cord injury (SCI) and are experiencing low blood pressure (hypotension) or sudden drops in blood pressure when standing up (orthostatic hypotension). Researchers want to find out if TSCS is safe and effective in improving blood pressure control during inpatient rehabilitation. You might be able to join if you are 14 to 100 years old, recently had a traumatic SCI, are in rehabilitation at Mount Sinai, and have low blood pressure or orthostatic hypotension. The study aims to measure how well TSCS works and if it causes any side effects over a period of up to four months.

Study design
This is an interventional study with a planned enrollment of 50 participants. The study will investigate the effects of transcutaneous spinal cord stimulation.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed during acute inpatient rehabilitation, which can be up to four months after their spinal cord injury.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06000592

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

Recruiting
NAAges 14+InterventionalTreatment
Jill M. Wecht, Ed.D.
~50 participants
Updated 2024-04-02 on ClinicalTrials.gov
What's tested:Digitimer

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The efficacy (#1) of TSCS to improve autonomic control following acute SCI.
Measured over Acute Inpatient Rehabilitation following SCI (up to 4 months)
+2 more outcomes measured

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

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Thomas N Bryce, MD · STUDY_DIRECTOR · Icahn School of Medicine at Mount Sinai

Who to contact

Jorge Chavez, BS
[email protected]
(914)343-0713
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • The efficacy (#1) of TSCS to improve autonomic control following acute SCI.Acute Inpatient Rehabilitation following SCI (up to 4 months)

    Blood pressure changes (mmHg) during the sit-up test with TSCS compared to no stimulation.

  • The safety (#1) of TSCS to improve autonomic control following acute SCI.Acute Inpatient Rehabilitation following SCI (up to 4 months)

    Assess pain levels using a Likert Scale 0-10 (0=no pain, 10=worst pain).

  • The safety (#2) of TSCS to improve autonomic control following acute SCI.Acute Inpatient Rehabilitation following SCI (up to 4 months)

    Document any skin changes (burns) following use of TSCS in count of occurrences.