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TSCS for Acute Spinal Cord Injury

This study is looking at a new way to help people with acute spinal cord injury (SCI) manage their blood pressure during rehabilitation. After a spinal cord injury, blood pressure can be unstable, which can make physical therapy difficult. This study will use Transcutaneous Spinal Cord Stimulation (TSCS), a device that delivers electrical stimulation through the skin, to help stabilize blood pressure. Researchers want to see if TSCS is safe and effective for this purpose. You might be able to join if you are 18-89 years old, have a new spinal cord injury, and experience blood pressure instability like low resting blood pressure or a significant drop in blood pressure when you stand up (orthostatic hypotension). The study will measure changes in your blood pressure and dizziness during a sit-up test, both with and without TSCS, weekly until you leave the hospital.

Study design
This is an interventional study with a planned enrollment of 50 participants. The phase of the study is not specified.
What's involved
Before starting TSCS, you will have a TSCS Mapping procedure. TSCS will then be used 3-5 times per week during your physical and occupational therapy sessions for the duration of your inpatient hospitalization.
Compensation
Not stated in the trial record.
Follow-up
Your blood pressure, heart rate, and dizziness will be measured weekly until discharge, with an average taken over 3 weeks.

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NCT05305118

TSCS for Acute SCI

Recruiting
NAAges 18–89InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~50 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:TSCS MappingTranscutaneous spinal cord stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sit-up Test - Blood Pressure (BP) with and without stimulation.
Measured over weekly until discharge, average of 3 weeks
+2 more outcomes measured

Conditions

Acute Spinal Cord Injury
Blood Pressure
Hypotension

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Jill Wecht, EdD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Genevieve Curtis
[email protected]
(617) 922-3141
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

All newly injured patients with SCI who are sequentially admitted during the 42-month recruitment period
Meet the following Model Systems entry criteria with evidence of BP instability
Exhibit one or more of the following: Resting hypotension - systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females; OH - fall in systolic BP ≥ 20 mmHg and/or a fall in diastolic BP ≥ 10 mmHg within 10 minutes of assuming an upright position; BP instability - fluctuation in systolic BP ≥ 20 mmHg and/or fluctuation in diastolic BP ≥ 10 mmHg within a single day during routine activities in the AIR setting.
Have trouble with your blood pressure as determined by your doctor.
Participants must be between the ages of 18-89 years old, experienced a spinal cord injury (SCI) within the past 30 days to 6 months, have sustained a SCI with temporary or permanent loss of sensory and/or motor function, and are an inpatient for acute SCI rehabilitation therapy at Mount Sinai.
You are not dependent on a ventilator at this time.
You do not have a history of implanted pacemaker/defibrillator or significant coronary artery disease.

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

  • Sit-up Test - Blood Pressure (BP) with and without stimulation.weekly until discharge, average of 3 weeks

    A brachial BP cuff (Series 400, GE Healthcare, Milwaukee, WI, USA) a finger BP monitor (Finometer ® MIDI Model-2; Finopres Medical Systems BV, Amsterdam, The Netherlands) will be applied. Brachial BP will be monitored at 1-minute intervals for 10-minutes in the supine and 10-minutes in the seated positions.

  • Severity of Dizziness Scaleweekly until discharge, average of 3 weeks

    The severity of orthostatic dizziness will be assessed at 0, 3, 7 and 10 minutes during the seated BP assessment using a scale from 0 to 10, where 0=no dizziness and 10=severe dizziness.

  • Sit-up Test - Heart Rate (HR) with and without stimulation.weekly until discharge, average of 3 weeks

    A 3-lead electrocardiogram (ECG) (RESP1 Impedance Pneumograph, Moro Bay, CA, USA) will be used to determine HR and to estimate parameters of autonomic cardiac control with the recording electrode in the V5 position (immediately below the left anterior axillary line on the same horizontal plane as the 5th intercostal space).