Transcutaneous Stimulation in Spinal Cord Injury (SCI)

September 19, 2025 updated by: VA Office of Research and Development

Targeted Transcutaneous Stimulation to Restore Autonomic Cardiovascular Health in Veterans With Spinal Cord Injury

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 seated blood pressure. The study will take approximately 1 to 13 study visits, of between 3-5 hours, per participant.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10468-3904
        • James J. Peters VA Medical Center, Bronx, NY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Without Stimulation
Seated blood pressure without transcutaneous spinal cord stimulation will be assessed.
Active Comparator: With Stimulation
Seated blood pressure with transcutaneous spinal cord stimulation will be assessed.
Device: DS8R
transcutaneous stimulation of the spinal cord.
Other Names:
  • Transcutaneous Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seated Systolic Blood Pressure
Time Frame: From enrollment to the end of the last study visit, approximately 30 days.
Seated systolic blood pressure response to spinal cord stimulation at T7/T8, T9/10, T11/12, L1/L2) to determine the best cathode electrode placement on the spine that increases systolic blood pressure between 110-130 mmHg.
From enrollment to the end of the last study visit, approximately 30 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: through study completion, up to 2 years
Determine the differences in systolic blood pressure during an orthostatic tilt without stimulation and with optimal stimulation.
through study completion, up to 2 years
Concentration of Norepinephrine
Time Frame: through study completion, up to 2 years
Determine the differences in norepinephrine during an orthostatic tilt without stimulation and with optimal stimulation.
through study completion, up to 2 years
Velocity of Arterial stiffness
Time Frame: through study completion, up to 2 years
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.
through study completion, up to 2 years
Concentration of Renin
Time Frame: through study completion, an average of 2 years
Determine the differences in renin during an orthostatic tilt without stimulation and with optimal stimulation.
through study completion, an average of 2 years
Concentration of Aldosterone
Time Frame: through study completion, an average of 2 years
Determine the differences in aldosterone during an orthostatic tilt without stimulation and with optimal stimulation.
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

Kessler Foundation

Investigators

  • Principal Investigator: Caitlyn Peters, PhD, James J. Peters Veterans Affairs Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

December 30, 2021

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B3706-M
  • IK1RX003706 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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