Acute Spinal Cord InjuryNCT05305118
TSCS for Acute SCI
A study testing TSCS Mapping and Transcutaneous spinal cord stimulation in people with Acute Spinal Cord Injury and Blood Pressure, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This project will focus on a novel approach to stabilizing blood pressure (BP) during inpatient rehabilitation after acute SCI. After SCI, people have unstable blood pressure, ranging from too low (orthostatic hypotension) to too high (autonomic dysreflexia). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Acute Spinal Cord Injury, Blood Pressure, Hypotension
- What is being tested?
- TSCS Mapping and Transcutaneous spinal cord stimulation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2022to 12 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Cancer
- Deemed unsuitable by study physician
- As part of the feasibility assessment, the study team will document demographic and injury characteristics of eligible patients who refuse enrollment, as well as reasons for ineligibility among those who do not meet entrance criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Spinal Cord Injury Model System
New York, New York, 10029
Jorge Chavez, B.S., 914-343-0713, Jorge.Chavez2@mountsinai.org
Jill Wecht, EdD
About this study
Official title: Safety, Feasibility, and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients With Spinal Cord Injury
This project will focus on a novel approach to stabilizing blood pressure (BP) during inpatient rehabilitation after acute SCI. After SCI, people have unstable blood pressure, ranging from too low (orthostatic hypotension) to too high (autonomic dysreflexia). Unstable BP often interferes with performing effective physical rehabilitation after SCI. A critical need exists for the identification of safe, practical and effective treatment options that stabilize BP after traumatic SCI. Transcutaneous Spinal Cord Stimulation (TSCS) has several advantages over pharmacological approaches: (1) does not exacerbate polypharmacy, (2) can be activated/deactivated rapidly, and (3) can be applied in synergy with physical exercise. The study team is asking the key question: "What if applying TSCS earlier after injury could prevent the development of BP instability?" To facilitate adoption of TSCS for widespread clinical use, the study team plans to map and develop a parameter configuration that will result in an easy to follow algorithm to maximize individual benefits, while minimizing the burden on healthcare professionals. This project will provide the foundational evidence to support the feasible and safe application of TSCS in the newly injured population, thereby overcoming barriers to engagement in prescribed inpatient rehabilitation regimens that are imposed by BP instability.
Read the detailed description
This site-specific project will focus on a novel non-pharmacologic approach to stabilizing blood pressure (BP) during acute inpatient rehabilitation after acute traumatic spinal cord injury (SCI). Current forms of pharmacologic and non-pharmacologic treatments for hypotension and orthostatic hypotension remain inadequate in the SCI population. A critical need exists for the identification of safe, practical and effective treatment options that stabilize BP after traumatic SCI as low BP limits the ability of individuals from fully participating in acute rehabilitation therapies. Transcutaneous Spinal Cord Stimulation (TSCS) has several advantages including being able to be activated/deactivated rapidly and the ability to be used during inpatient therapy for rehabilitation following SCI. The study team is asking the key question: "What is the safety and feasibility of applying TSCS in acute SCI to prevent the development of BP instability?" To facilitate adoption of TSCS for widespread clinical use, the study team has designed a mapping and parameter configuration protocol to develop 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 in the newly injured SCI population, thereby overcoming one of the major barriers (i.e., low BP) that prevents full participation in acute SCI rehabilitation.
- Conditions
- Acute Spinal Cord Injury, Blood Pressure, Hypotension
- Being tested
- TSCS Mapping, Transcutaneous spinal cord stimulation
- Keywords
- Transcutaneous Spinal Cord Stimulation, Neuromodulation, Spinal Cord Stimulation, Blood Pressure Disorders, Cerebral Blood Flow Velocity, Acute Inpatient Rehabilitation
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSCS MappingProcedure or surgery
Prior to TSCS Intervention, participants will undergo TSCS Mapping.
Electrode location, pulse frequency will be maintained while the stimulation intensity is ramped from 10 to 200 mA. Brachial blood pressures and symptoms will be monitored and recorded at each ramping interval and will continuously monitor and record beat-to-beat heart rate and blood pressures to determine the optimal site and frequency for further TSCS intervention
TSCS electrodes will be placed at two vertebral levels in the and back and pulse frequency will be set at 30 to 240 Hz to determine the optimal site and frequency for further TSCS intervention.
Transcutaneous spinal cord stimulationDevice
Also called TSCS
TSCS will be used as an adjunct intervention to promote blood pressure stability in conjunction with daily physical and occupational therapy in the inpatient rehabilitation gym. Stimulation will be added to therapy 3-5 times per week as needed for the duration of inpatient hospitalization following SCI.
TSCS stimulation will be delivered using Digitimer DS7A, DS8R stimulators and Chattanooga Continuum (DS7A has FDA 510(k) clearance #K051357; Chattanooga Continuum is a Class 2 device).
| Study group | Role | What they receive |
|---|---|---|
| Acute Inpatients With Spinal Cord Injury | Experimental | Inpatient participants undergoing rehabilitation after acute traumatic SCI. Receives: Procedure: TSCS Mapping; Device: Transcutaneous spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sit-up Test - Blood Pressure (BP) with and without stimulation.
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.
Measured: weekly until discharge, average of 3 weeks
Severity of Dizziness Scale
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.
Measured: weekly until discharge, average of 3 weeks
Sit-up Test - Heart Rate (HR) with and without stimulation.
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).
Measured: weekly until discharge, average of 3 weeks
Secondary outcomes (1)
Pain Numeric Rating Scale (NPRS)
Pain scale from 0-10, with higher score indicating more severe pain
Measured: weekly until discharge, average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start18 Mar 2022
- Primary completion12 Jan 2027 (estimated)
- Study completion12 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- James J. Peters Veterans Affairs Medical Center
- Responsible party
- Principal investigator, Jill Wecht, Icahn School of Medicine at Mount Sinai
- Investigators
- Jill Wecht, EdD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305118
- Sponsor's protocol ID
- STUDY-21-01475
- Other IDs
- 1648740
- Status last verified
- Aug 2026
- First submitted
- 22 Mar 2022
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).