TSCS for Acute SCI

NCT05305118 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY-21-014751648740
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Acute Spinal Cord Injury; Blood Pressure; Hypotension

Keywords

Transcutaneous Spinal Cord Stimulation; Neuromodulation; Spinal Cord Stimulation; Blood Pressure Disorders; Cerebral Blood Flow Velocity; Acute Inpatient Rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  weekly until discharge, average of 3 weeks

Secondary Outcomes (1)

• Pain Numeric Rating Scale (NPRS)

  weekly until discharge, average of 3 weeks

Study Arms (1)

Acute Inpatients With Spinal Cord Injury

EXPERIMENTAL

Inpatient participants undergoing rehabilitation after acute traumatic SCI.

Procedure: TSCS Mapping; Device: Transcutaneous spinal cord stimulation

Interventions

TSCS Mapping PROCEDURE

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.

Acute Inpatients With Spinal Cord Injury

Transcutaneous spinal cord stimulation DEVICE

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).

Also known as: TSCS

Acute Inpatients With Spinal Cord Injury

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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
• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• James J. Peters Veterans Affairs Medical Center: collaborator

Study Sites (1)

Mount Sinai Spinal Cord Injury Model System

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jill Wecht, EdD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Genevieve Curtis

CONTACT

(617) 922-3141; genevieve.curtis@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Rehabilitation Medicine

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: January 1, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be tbd).

Locations

US (1)