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TSCS for Acute SCI

Primary Purpose

Acute Spinal Cord Injury, Blood Pressure, Hypotension

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

TSCS Mapping

Transcutaneous spinal cord stimulation

About this trial

This is an interventional treatment trial for Acute Spinal Cord Injury focused on measuring Transcutaneous Spinal Cord Stimulation, Neuromodulation, Spinal Cord Stimulation, Blood Pressure Disorders, Cerebral Blood Flow Velocity, Acute Inpatient Rehabilitation

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Participants must have reached the age of 18, have sustained a SCI with temporary or permanent loss of sensory and/or motor function, and have been admitted to an spinal cord injury (SCI) Acute Inpatient Rehabilitation (AIR) unit within MSHS within one year of injury.

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

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.

Sites / Locations

Mount Sinai Spinal Cord Injury Model SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute Inpatients With Spinal Cord Injury

Arm Description

Inpatient participants undergoing rehabilitation after acute traumatic SCI.

Outcomes

Primary Outcome Measures

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.

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.

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).

Sit-Up Test - Cerebral Blood Flow velocity (CBFv) with and without stimulation.

A transcranial Doppler (TCD) ultrasound probe (Terumo Cardiovascular Systems, Tustin, CA, USA) will be used to visualize the middle cerebral artery (MCA). The TCD probe will be operated at a frequency of 2.0 MHz to visualize the left and right MCA through the temporal window, which will be identified by the depth (45-55 mm), sound and direction of flow (towards the probe), as evidenced by the color and spectral waveform. Once the MCA has been visualized a head-harness will be used to secure the probe position for the duration of testing and will report mean CBFv (cm/sec), as a surrogate of cerebral blood flow. CBFv will be continuously monitored and recorded at 1-minute intervals, for 10-minutes in the supine and 10 minutes in the seated positions.

Forced Vital Capacity (FVC) With Simulation

A handheld spirometer will be used to measure forced vital capacity as a measure of lung function. While seated, and after a mouthpiece and nose clip are applied, they will breathe normally for 3 to 6 breaths and then forcibly inhale until their lungs are filled. After a brief pause, they will forcibly exhale for at least 6 seconds. After a brief rest, this maneuver will be repeated a minimum of three and maximum of five times to ensure consistent values, will record the average of 3-5 assessments.

Forced Vital Capacity (FVC) Without Simulation

Secondary Outcome Measures

Pain Numeric Rating Scale (NPRS)

Pain scale from 0-10, with higher score indicating more severe pain

International SCI Pain Basic Data Set (ISCIPBDS)

If a participant indicates new pain during/after TSCS, the new pain's location, intensity, and quality will be identified using the pain location chart from the International SCI Pain Basic Data Set (ISCIPBDS).

Spinal Cord Injury Pain Instrument (SCIPI)

4-item screening tool to assess if the new pain is likely of neuropathic etiology. a score of 1 is given to each positive item and a score of 0 to each negative item. The total score is calculated as a sum of the four items with a score of 0 indicating NNP, a score of 1 indicating possible neuropathic pain (NP) and a score of 2 or greater indicating probable NP.

Autonomic Dysreflexia (AD) Symptoms Survey

The 5-question AD survey queries participants on the symptoms of AD, ranging from sweating and pounding headache to chills and goose bumps, that they experienced over the preceding 7-day period. Full scale range is from 0-10, higher score indicates more symptom reporting.

Orthostatic Hypotension (OH) Symptoms Survey

The 10-question OH survey queries participants on the symptoms of hypotension and OH, ranging from dizziness and light headedness to fatigue and nausea, that they experienced over the preceding 7-day period. Full scale range is from 0-10, higher score indicates more symptom reporting.

Number of treatment sessions

The number of treatment sessions that were conducted with TSCS each week

Number of exercise sessions in which TSCS is omitted during therapy

Number and the reasons for omitting the use of TSCS during therapy

Upper Extremity Muscle Strength (UEMS) Testing

Five arm muscles on each side will be assessed using manual muscle testing, scored 0 (no muscle contraction palpated or observed) to 5 (full strength) with and without stimulation.

Lower Extremity Muscle Strength (LEMS) Testing

Leg muscles on each side will be assessed using manual muscle testing, scored 0 (no muscle contraction palpated or observed) to 5 (full strength) with and without stimulation.

Full Information

NCT ID

NCT05305118

First Posted

March 22, 2022

Last Updated

January 5, 2023

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

James J. Peters Veterans Affairs Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05305118

Brief Title

TSCS for Acute SCI

Official Title

Safety, Feasibility, and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients With Spinal Cord Injury

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 18, 2022 (Actual)

Primary Completion Date

March 2026 (Anticipated)

Study Completion Date

October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

James J. Peters Veterans Affairs Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acute Inpatients With Spinal Cord Injury

Arm Type

Experimental

Arm Description

Inpatient participants undergoing rehabilitation after acute traumatic SCI.

Intervention Type

Procedure

Intervention Name(s)

TSCS Mapping

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Transcutaneous spinal cord stimulation

Other Intervention Name(s)

TSCS

Intervention Description

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).

Primary Outcome Measure Information:

Title

Sit-up Test - Blood Pressure (BP) with and without stimulation.

Description

Time Frame

weekly until discharge, average of 3 weeks

Title

Severity of Dizziness Scale

Description

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.

Time Frame

weekly until discharge, average of 3 weeks

Title

Sit-up Test - Heart Rate (HR) with and without stimulation.

Description

Time Frame

weekly until discharge, average of 3 weeks

Title

Sit-Up Test - Cerebral Blood Flow velocity (CBFv) with and without stimulation.

Description

Time Frame

weekly until discharge, average of 3 weeks

Title

Forced Vital Capacity (FVC) With Simulation

Description

Time Frame

weekly until discharge, average of 3 weeks

Title

Forced Vital Capacity (FVC) Without Simulation

Description

Time Frame

weekly until discharge, average of 3 weeks

Secondary Outcome Measure Information:

Title

Pain Numeric Rating Scale (NPRS)

Description

Pain scale from 0-10, with higher score indicating more severe pain

Time Frame

weekly until discharge, average of 3 weeks

Title

International SCI Pain Basic Data Set (ISCIPBDS)

Description

Time Frame

weekly until discharge, average of 3 weeks

Title

Spinal Cord Injury Pain Instrument (SCIPI)

Description

Time Frame

weekly until discharge, average of 3 weeks

Title

Autonomic Dysreflexia (AD) Symptoms Survey

Description

Time Frame

weekly until discharge, average of 3 weeks

Title

Orthostatic Hypotension (OH) Symptoms Survey

Description

Time Frame

weekly until discharge, average of 3 weeks

Title

Number of treatment sessions

Description

The number of treatment sessions that were conducted with TSCS each week

Time Frame

weekly until discharge, average of 3 weeks

Title

Number of exercise sessions in which TSCS is omitted during therapy

Description

Number and the reasons for omitting the use of TSCS during therapy

Time Frame

weekly until discharge, average of 3 weeks

Title

Upper Extremity Muscle Strength (UEMS) Testing

Description

Five arm muscles on each side will be assessed using manual muscle testing, scored 0 (no muscle contraction palpated or observed) to 5 (full strength) with and without stimulation.

Time Frame

weekly until discharge, average of 3 weeks

Title

Lower Extremity Muscle Strength (LEMS) Testing

Description

Leg muscles on each side will be assessed using manual muscle testing, scored 0 (no muscle contraction palpated or observed) to 5 (full strength) with and without stimulation.

Time Frame

weekly until discharge, average of 3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Participants must have reached the age of 18, have sustained a SCI with temporary or permanent loss of sensory and/or motor function, and have been admitted to an spinal cord injury (SCI) Acute Inpatient Rehabilitation (AIR) unit within MSHS within one year of injury. 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jorge Chavez, BS

Phone

914-343-0713

Jorge.Chavez2@mountsinai.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jill Wecht, EdD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Sinai Spinal Cord Injury Model System

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jorge Chavez, B.S.

Phone

914-343-0713

Jorge.Chavez2@mountsinai.org

First Name & Middle Initial & Last Name & Degree

Jill Wecht, EdD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing 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).

Learn more about this trial

TSCS for Acute SCI

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