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Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI

Primary Purpose

Acute Spinal Cord Injury, Spinal Cord Injuries, Neuromodulation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digitimer
Sponsored by
Jill M. Wecht, Ed.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Spinal Cord Injury

Eligibility Criteria

14 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Newly injured patients with traumatic SCI Admitted to Acute Inpatient Rehabilitation at Mount Sinai Within one year of SCI Seated hypotension (systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females) Orthostatic hypotension (fall in systolic BP ≥ 20 mmHg and/or a fall in diastolic BP ≥ 10 mmHg within 10 minutes of assuming an upright position) Daily fluctuation in systolic BP ≥ 20 mmHg and/or fluctuation in diastolic BP ≥ 10 mmHg At least 14 years old 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

Sites / Locations

  • The Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

transcutaneous spinal stimulation

Arm Description

Outcomes

Primary Outcome Measures

The safety (#1) of TSCS to improve autonomic control following acute SCI.
Assess pain levels using a Likert Scale 0-10 (0=no pain, 10=worst pain).
The safety (#2) of TSCS to improve autonomic control following acute SCI.
Document any skin changes (burns) following use of TSCS in count of occurrences.
The efficacy (#1) of TSCS to improve autonomic control following acute SCI.
Blood pressure changes (mmHg) during the sit-up test with TSCS compared to no stimulation.

Secondary Outcome Measures

The efficacy (#2) of TSCS to improve autonomic control following acute SCI.
To compare dizziness symptoms on a Likert Scale 0-10 (0=no dizziness, 10=worst dizziness) during the sit-up test with TSCS compared to no stimulation..

Full Information

First Posted
June 23, 2023
Last Updated
August 17, 2023
Sponsor
Jill M. Wecht, Ed.D.
Collaborators
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT06000592
Brief Title
Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With 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
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jill M. Wecht, Ed.D.
Collaborators
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This site-specific project will focus on a novel non-pharmacologic approach to stabilizing BP during AIR after acute traumatic SCI. Current forms of pharmacologic and non-pharmacologic treatments for hypotension and OH 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. Transcutaneous Spinal Cord Stimulation (TSCS) has several advantages: (1) does not exacerbate polypharmacy, (2) can be activated/deactivated rapidly, and (3) can be applied in synergy with physical exercise. TSCS represents an alternate approach to epidural SCS, with far greater potential to reach large numbers of individuals, thus providing for a greater likelihood of clinical implementation with far fewer risks. We are asking the key question: what if applying SCS earlier after injury could prevent the development of BP instability? To facilitate adoption of TSCS for widespread clinical use, we have designed a spatial-temporal mapping and parameter configuration approach that will result in a key deliverable for SCI care: 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 for widespread clinical utility in the newly injured population, thereby overcoming barriers to engagement in prescribed AIR regimens that are imposed by ANS dysfunction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Spinal Cord Injury, Spinal Cord Injuries, Neuromodulation, Traumatic Spinal Cord Injury, Spinal Cord Stimulation, SCI - Spinal Cord Injury, Blood Pressure, Blood Pressure Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Participant awareness during TSCS appears to be unavoidable. The FDA recognizes that some trials of non-pharmacological interventions cannot be fully shammed or blinded, yet with careful blinding of data assessors, it is possible to obtain reliable results that meet FDA approval criteria.
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transcutaneous spinal stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Digitimer
Intervention Description
transcutaneous spinal cord stimulation for blood pressure control following spinal cord injury.
Primary Outcome Measure Information:
Title
The safety (#1) of TSCS to improve autonomic control following acute SCI.
Description
Assess pain levels using a Likert Scale 0-10 (0=no pain, 10=worst pain).
Time Frame
Acute Inpatient Rehabilitation following SCI (up to 4 months)
Title
The safety (#2) of TSCS to improve autonomic control following acute SCI.
Description
Document any skin changes (burns) following use of TSCS in count of occurrences.
Time Frame
Acute Inpatient Rehabilitation following SCI (up to 4 months)
Title
The efficacy (#1) of TSCS to improve autonomic control following acute SCI.
Description
Blood pressure changes (mmHg) during the sit-up test with TSCS compared to no stimulation.
Time Frame
Acute Inpatient Rehabilitation following SCI (up to 4 months)
Secondary Outcome Measure Information:
Title
The efficacy (#2) of TSCS to improve autonomic control following acute SCI.
Description
To compare dizziness symptoms on a Likert Scale 0-10 (0=no dizziness, 10=worst dizziness) during the sit-up test with TSCS compared to no stimulation..
Time Frame
Acute Inpatient Rehabilitation following SCI (up to 4 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly injured patients with traumatic SCI Admitted to Acute Inpatient Rehabilitation at Mount Sinai Within one year of SCI Seated hypotension (systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females) Orthostatic hypotension (fall in systolic BP ≥ 20 mmHg and/or a fall in diastolic BP ≥ 10 mmHg within 10 minutes of assuming an upright position) Daily fluctuation in systolic BP ≥ 20 mmHg and/or fluctuation in diastolic BP ≥ 10 mmHg At least 14 years old 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
Facility Information:
Facility Name
The Icahn School of Medicine at Mount Sinai
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
Miguel Escalón, MD, MPH
Phone
212-241-6321
Email
miguel.escalon@mountsinai.org

12. IPD Sharing Statement

Learn more about this trial

Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI

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