TSCS for Acute SCI

• ClinicalTrials.gov Identifier: NCT05305118
• Recruitment Status: Recruiting
• First Posted: March 31, 2022
• Last Update Posted: January 9, 2023
• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: James J. Peters Veterans Affairs Medical Center
• Information provided by (Responsible Party): Jill Wecht, Icahn School of Medicine at Mount Sinai

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.

Condition or disease	Intervention/treatment	Phase
Acute Spinal Cord Injury; Blood Pressure; Hypotension	Procedure: TSCS Mapping; Procedure: Transcutaneous spinal cord stimulation	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety, Feasibility, and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients With Spinal Cord Injury
• Actual Study Start Date: March 18, 2022
• Estimated Primary Completion Date: March 2026
• Estimated Study Completion Date: October 2026

Arms and Interventions

Arm

Intervention/treatment

Experimental: Acute Inpatients With Spinal Cord Injury; Inpatient participants undergoing rehabilitation after acute traumatic SCI.

Procedure: TSCS Mapping; 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.; Procedure: Transcutaneous spinal cord stimulation; 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).; Other Name: TSCS

Outcome Measures

Primary Outcome Measures :

1. Sit-up Test - Blood Pressure (BP) with and without stimulation. [ Time Frame: 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.
2. Severity of Dizziness Scale [ Time Frame: weekly 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.
3. Sit-up Test - Heart Rate (HR) with and without stimulation. [ Time Frame: 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).
4. Sit-Up Test - Cerebral Blood Flow velocity (CBFv) with and without stimulation. [ Time Frame: weekly until discharge, average of 3 weeks ]

   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.

5. Forced Vital Capacity (FVC) With Simulation [ Time Frame: weekly until discharge, average of 3 weeks ]
   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.
6. Forced Vital Capacity (FVC) Without Simulation [ Time Frame: weekly until discharge, average of 3 weeks ]
   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.

Secondary Outcome Measures :

1. Pain Numeric Rating Scale (NPRS) [ Time Frame: weekly until discharge, average of 3 weeks ]
   Pain scale from 0-10, with higher score indicating more severe pain
2. International SCI Pain Basic Data Set (ISCIPBDS) [ Time Frame: weekly until discharge, average of 3 weeks ]
   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).
3. Spinal Cord Injury Pain Instrument (SCIPI) [ Time Frame: weekly until discharge, average of 3 weeks ]
   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.
4. Autonomic Dysreflexia (AD) Symptoms Survey [ Time Frame: weekly until discharge, average of 3 weeks ]
   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.
5. Orthostatic Hypotension (OH) Symptoms Survey [ Time Frame: weekly until discharge, average of 3 weeks ]
   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.
6. Number of treatment sessions [ Time Frame: weekly until discharge, average of 3 weeks ]
   The number of treatment sessions that were conducted with TSCS each week
7. Number of exercise sessions in which TSCS is omitted during therapy [ Time Frame: weekly until discharge, average of 3 weeks ]
   Number and the reasons for omitting the use of TSCS during therapy
8. Upper Extremity Muscle Strength (UEMS) Testing [ Time Frame: weekly until discharge, average of 3 weeks ]
   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.
9. Lower Extremity Muscle Strength (LEMS) Testing [ Time Frame: weekly until discharge, average of 3 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Jorge Chavez, BS; 914-343-0713; Jorge.Chavez2@mountsinai.org

Locations

United States, New York

Mount Sinai Spinal Cord Injury Model System; Recruiting

New York, New York, United States, 10029

Contact: Jorge Chavez, B.S. 914-343-0713 Jorge.Chavez2@mountsinai.org

Principal Investigator: Jill Wecht, EdD

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

James J. Peters Veterans Affairs Medical Center

Investigators

• Principal Investigator: Jill Wecht, EdD; Icahn School of Medicine at Mount Sinai

More Information

• Responsible Party: Jill Wecht, Professor, Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT05305118
• Other Study ID Numbers: STUDY-21-01475; 1648740 ( Other Identifier: James J. VA Medical Center )
• First Posted: March 31, 2022
• Last Update Posted: January 9, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• Supporting Materials: Study Protocol; Statistical Analysis Plan (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).

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Jill Wecht, Icahn School of Medicine at Mount Sinai:

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

Additional relevant MeSH terms:

Spinal Cord Injuries; Hypotension; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Vascular Diseases; Cardiovascular Diseases