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Transcutaneous Stimulation in Spinal Cord Injury (SCI)

Primary Purpose

Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DS8R
Orthostatic tilt
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Blood pressure, Orthostatic hypotension, Transcutaneous stimulation, Cardiovascular disease

Eligibility Criteria

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

Inclusion Criteria:

  • between the ages of 21-70 years old
  • individuals with traumatic spinal cord injuries at or above T6

    • duration of injury if more than 1 year
    • non-ambulatory
    • American spinal injury association scale A, B or C
  • able to provide consent
  • non-ventilator
  • hypotensive (males: systolic blood pressure less than 110 mmHg and/or diastolic blood pressure less than 70 mmHg; females: systolic blood pressure less than 100 mmHg and/or diastolic blood pressure less than 70 mmHg)
  • orthostatic hypotension (decrease in systolic blood pressure of at least 20 mmHg and/or decrease in diastolic blood pressure of at least 10 mmHg when moving from supine to upright position- will be determined in the screening process)

Exclusion Criteria:

  • acute illness or infection
  • current smokers within 1 year of study
  • documented history of controlled or uncontrolled diabetes
  • any other neurological disease other than spinal cord injury
  • cardiovascular disease (coronary artery disease, congestive heart failure, peripheral artery disease, stroke)
  • present of history of thrombosis in the last 12 months, severe contractures

Sites / Locations

  • James J. Peters VA Medical Center, Bronx, NYRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Without Stimulation

With Stimulation

Arm Description

Participant will complete an orthostatic challenge without transcutaneous stimulation.

Participant will complete an orthostatic challenge with transcutaneous stimulation.

Outcomes

Primary Outcome Measures

Electrode placement
Electrodes will be placed on the vertebral midline at the spinous process (T7/T8, T9/10, T11/12, L1/L2). Determine the best electrode placement on the spine that increases blood pressure between 110-120 mmHg for males and 100-120 mmHg for females in the seated position. The best electrode placement will be used to increase blood pressure during an orthostatic tilt.
Amplitude of TSCS
Amplitude of the stimulation will start at 0mA and increase in increments between 1 - 10mA to determine the best amplitude to increase systolic blood pressure between 110-120 mmHg for males and 100-120 mmHg for females. The same spinous process sites (T7/T8, T9/10, T11/12, L1/L2) will be used. The best amplitude will be used to increase blood pressure during an orthostatic tilt.

Secondary Outcome Measures

Systolic blood pressure
Determine the differences in systolic blood pressure during an orthostatic tilt without stimulation and with optimal stimulation.
Concentration of Norepinephrine
Determine the differences in norepinephrine during an orthostatic tilt without stimulation and with optimal stimulation.
Velocity of Arterial stiffness
Determine the differences in arterial stiffness during an orthostatic tilt without stimulation and with optimal stimulation. Arterial stiffness will be measured using pulse wave velocity of the carotid and femoral arteries. The unit of measure is velocity.
Concentration of Renin
Determine the differences in renin during an orthostatic tilt without stimulation and with optimal stimulation.
Concentration of Aldosterone
Determine the differences in aldosterone during an orthostatic tilt without stimulation and with optimal stimulation.

Full Information

First Posted
November 19, 2021
Last Updated
July 18, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05180227
Brief Title
Transcutaneous Stimulation in Spinal Cord Injury
Acronym
SCI
Official Title
Targeted Transcutaneous Stimulation to Restore Autonomic Cardiovascular Health in Veterans With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
March 29, 2024 (Anticipated)
Study Completion Date
March 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cardiovascular disease has become the leading cause of death in the spinal cord injury population. Increased reliance on the renin-angiotensin-aldosterone system (RAAS) is believed to decrease falls in blood pressure when moving from a laying down position to upright; however, findings in the general population link the RAAS with remodeling and restructuring of the arterial walls. Therefore, intervention to stabilize and normalize blood pressure should be a priority in individuals with spinal cord injury who have low blood pressure. Advances in stimulation on the skin of the spinal cord offer an approach to restore cardiovascular control and improve blood pressure regulation; however, electrode placement and stimulation parameters needed to increase blood pressure are not well understood. Therefore, the aim of the study is to identify placement of electrodes on the skin, and frequency and amplitude of the stimulation to regulate blood pressure.
Detailed Description
Although life expectancies have improved in the SCI population, longevity remains below the general population, due to increased incidence of cardiovascular disease, which is the leading cause of mortality in individuals with chronic SCI. Autonomic nervous system dysfunction and blood pressure instability contribute to the increased cardiovascular disease risk in the SCI population; however, because a majority of individuals with SCI remain asymptomatic the diagnosis and treatment of blood pressure instability is not a clinical priority. This is due, in part, to lack of safe and effective interventions, even though mounting evidence strongly supports adverse effects of blood pressure instability on the cerebral circulation, cognitive function, and quality of life. Identifying individualized transcutaneous stimulation parameters that safely and effectively increase and stabilize blood pressure in hypotensive individuals with SCI will provide the foundational evidence to support eventual wide-spread clinical utility throughout the VA healthcare system. 10 participants who are cleared, will go through multiple mapping sessions to find out the most appropriate electrode placement to increase blood pressure and then will perform an orthostatic provocation on a tilt table during stimulation to determine differences with stim and without. The study will take approximately 1 to 13 study visits, of between 3-5 hours, per participant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Blood pressure, Orthostatic hypotension, Transcutaneous stimulation, Cardiovascular disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will complete transcutanous stimulation mapping sessions to determine the optimal parameters to increase and maintain systolic blood pressure between 110-120 mmHg for males and 100-120 mmHg for females. The last two (or three) visits, the participants will be blinded to the order of completing an orthostatic tilt with and without stimulation. The third visit might be needed if the amplitude of the intensity that was found to be optimal in the seated position needs to be increased during a tilt to increase systolic blood pressure.
Masking
Participant
Masking Description
The last two (or three) visits, the participants will be blinded to the order of completing an orthostatic tilt with and without stimulation.
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Without Stimulation
Arm Type
Placebo Comparator
Arm Description
Participant will complete an orthostatic challenge without transcutaneous stimulation.
Arm Title
With Stimulation
Arm Type
Active Comparator
Arm Description
Participant will complete an orthostatic challenge with transcutaneous stimulation.
Intervention Type
Device
Intervention Name(s)
DS8R
Other Intervention Name(s)
Transcutaneous Stimulation
Intervention Description
transcutaneous stimulation of the spinal cord.
Intervention Type
Diagnostic Test
Intervention Name(s)
Orthostatic tilt
Intervention Description
perform an orthostatic tilt without and with stimulation.
Primary Outcome Measure Information:
Title
Electrode placement
Description
Electrodes will be placed on the vertebral midline at the spinous process (T7/T8, T9/10, T11/12, L1/L2). Determine the best electrode placement on the spine that increases blood pressure between 110-120 mmHg for males and 100-120 mmHg for females in the seated position. The best electrode placement will be used to increase blood pressure during an orthostatic tilt.
Time Frame
through study completion, up to 2 years
Title
Amplitude of TSCS
Description
Amplitude of the stimulation will start at 0mA and increase in increments between 1 - 10mA to determine the best amplitude to increase systolic blood pressure between 110-120 mmHg for males and 100-120 mmHg for females. The same spinous process sites (T7/T8, T9/10, T11/12, L1/L2) will be used. The best amplitude will be used to increase blood pressure during an orthostatic tilt.
Time Frame
through study completion, up to 2 years
Secondary Outcome Measure Information:
Title
Systolic blood pressure
Description
Determine the differences in systolic blood pressure during an orthostatic tilt without stimulation and with optimal stimulation.
Time Frame
through study completion, up to 2 years
Title
Concentration of Norepinephrine
Description
Determine the differences in norepinephrine during an orthostatic tilt without stimulation and with optimal stimulation.
Time Frame
through study completion, up to 2 years
Title
Velocity of Arterial stiffness
Description
Determine the differences in arterial stiffness during an orthostatic tilt without stimulation and with optimal stimulation. Arterial stiffness will be measured using pulse wave velocity of the carotid and femoral arteries. The unit of measure is velocity.
Time Frame
through study completion, up to 2 years
Title
Concentration of Renin
Description
Determine the differences in renin during an orthostatic tilt without stimulation and with optimal stimulation.
Time Frame
through study completion, an average of 2 years
Title
Concentration of Aldosterone
Description
Determine the differences in aldosterone during an orthostatic tilt without stimulation and with optimal stimulation.
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: above the age of 18 years old individuals with traumatic spinal cord injuries at or above T6 duration of injury if more than 1 year non-ambulatory American spinal injury association scale A, B or C able to provide consent non-ventilator hypotensive (males: systolic blood pressure less than 110 mmHg and/or diastolic blood pressure less than 70 mmHg; females: systolic blood pressure less than 100 mmHg and/or diastolic blood pressure less than 70 mmHg) Exclusion Criteria: acute illness or infection documented history of controlled or uncontrolled diabetes any other neurological disease other than spinal cord injury cardiovascular disease (coronary artery disease, congestive heart failure, peripheral artery disease, stroke) present of history of thrombosis in the last 12 months, severe contractures pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caitlyn Peters, PhD
Phone
(718) 584-9000
Email
Caitlyn.Katzelnick@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Wecht, EdD
Phone
(718) 584-9000
Ext
3122
Email
jm.wecht@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caitlyn Peters, PhD
Organizational Affiliation
James J. Peters Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
James J. Peters VA Medical Center, Bronx, NY
City
Bronx
State/Province
New York
ZIP/Postal Code
10468-3904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlyn Peters, PhD
Phone
718-584-9000
Email
Caitlyn.Katzelnick@va.gov
First Name & Middle Initial & Last Name & Degree
Jill Wecht, EdD
Phone
(718) 584-9000
Ext
3122
Email
jm.wecht@va.gov
First Name & Middle Initial & Last Name & Degree
Caitlyn Peters, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Transcutaneous Stimulation in Spinal Cord Injury

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