Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury

August 29, 2025 updated by: Einat Haber, Kessler Foundation

Assessing Cardiovascular Effects: Is There a Time Too Early for Spinal Stimulation in Acute SCI? A Year-Long Evaluation of Autonomic Function Following Injury

The study aims to explore how cardiovascular function changes in the first year after a spinal cord injury, and to see how different treatments, like spinal stimulation through the skin (transcutaneous spinal stimulation), affect blood pressure.

The main questions are:

How does stimulation affect blood pressure over the year? What is the level of cardiovascular activation throughout the year?

The study will start during the inpatient stay at the Kessler Institute for Rehabilitation and continue after discharge as an outpatient, totaling about 20-29 sessions over the year.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical study investigates the cardiovascular effects of spinal cord transcutaneous stimulation (scTS) in individuals with recent spinal cord injury (SCI), examining how blood pressure response to stimulation evolves over the first year post-injury. The primary objectives are to determine the optimal timing for initiating scTS for cardiovascular control, characterize blood pressure response evolution to stimulation over one year, and assess autonomic activation patterns through multiple testing methods.

The study will recruit five individuals with recent SCI, specifically targeting those who are 50 days or less post-injury, with an injury level at or above T6, and classified as American Spinal Injury Association Impairment Scale (AIS) A/B. All participants must present with low blood pressure and orthostatic hypotension and be between 18-75 years of age.

The study protocol is divided into inpatient and outpatient phases. During the inpatient phase, consisting of 5-11 sessions, participants undergo a basic assessment including autonomic dysfunction questionnaires, 24-hour blood pressure monitoring, cold pressor testing, and tilt tests with and without stimulation. The protocol also includes 2-3 days of stimulation mapping.

The outpatient phase spans 15-18 sessions over the remainder of the year. Participants undergo monthly mapping sessions and autonomic dysfunction assessments, with comprehensive autonomic testing conducted at 6, 9, and 12 months post-injury. Throughout both phases, researchers perform stimulation mapping across various spinal segments (thoracic, lumbosacral) using a 5-channel electrical stimulator, while monitoring blood pressure and electromyography to target a blood pressure range of 110-120 mmHg.

The study employs multiple assessment tools, including 70° tilt tests with orthostatic symptom evaluation every 5 minutes, cold pressor tests, autonomic dysfunction questionnaires, and 24-hour ambulatory blood pressure monitoring.

The study aims to track primary outcomes including blood pressure response to stimulation at different time points, evolution of orthostatic hypotension symptoms and management, and the pattern of autonomic dysfunction development post-injury.

Study Type

Interventional

Enrollment (Estimated)

5

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 Contact

Study Locations

  • United States
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Recruiting
        • Kessler Foundation

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals with a spinal cord injury undergoing inpatient rehabilitation at the Kessler Institute for Rehabilitation
  • Between 18-75 years old
  • 7-50 days after injury
  • Injury level ≥ T6 (a cervical or a high-level chest injury)
  • Individuals experiencing low blood pressure after the injury
  • American Spinal Injury Association Impairment Scale (AIS) A or B

Exclusion Criteria:

  • A ventilator is needed for breathing.
  • Devices such as brain/spine/nerve stimulators, a cardiac pacemaker/defibrillator, or intra-cardiac lines are present in the body.
  • There is a significant disease affecting the blood vessels or signals in the heart, or a recent heart attack (myocardial infarction) has occurred.
  • A new medication has been prescribed to treat blood pressure or a heart problem within the last five days (excluding midodrine).
  • There is a known infection in the body (e.g., urinary tract infection) or a current illness (e.g., recent diagnosis of deep vein thrombosis (DVT) or other blood clotting issues, and/or a pressure injury that might interfere with the study).
  • There is a history of seizures.
  • Pregnancy.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure in seated mapping sessions
Time Frame: The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.
Spatiotemporal mapping sessions involving stimulation of various spinal segments, utilizing different parameters (e.g., frequency, waveform). A BP response in a mapping session will be defined by a significant increase in SBP of at least 20 mmHg with stimulation compared to baseline SBP (without stimulation)
The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.
systolic blood pressure in a 70 degree tilt
Time Frame: The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately every three months
In this study, tilt-tests are conducted in pairs: first, a standard tilt test (without stimulation), followed by a tilt test with stimulation aimed at preventing orthostatic hypotension. We will compare the drop in systolic blood pressure during the tilt test with stimulation to the drop observed in the standard tilt test.
The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately every three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cold pressor test
Time Frame: The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately every three months
In a traditional cold pressor test, the foot is immersed in 0°C ice water, indirectly assessing the degree of sympathetic activation through BP and HR
The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately every three months
24-hour ambulatory blood pressure monitoring
Time Frame: The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.
Parameters are recorded automatically every 15 min during the day and every 60 min at night. Participants will be asked to take notes regarding BP-related symptoms, activities, and their time points.
The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.
An autonomic dysfunction following spinal cord injury questionnaire
Time Frame: The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.
Assessing the severity and frequency of daily AD and OH episodes and their effect on daily activities
The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.

Collaborators and Investigators

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

Sponsor

Kessler Foundation

Investigators

  • Principal Investigator: Einat Engel-Haber, MD, Kessler Foundation

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)

April 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

February 24, 2025

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R1287-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All human subject SCI data will be de-identified. Data shared via a public repository will include demographics (sex, age), injury characteristics (etiology, level and severity of injury), BP measures (systolic, diastolic and heart rate) from mapping, tilt, and 24-hr monitoring data, tilt data (angle, duration, orthostatic questionnaire scores), stimulation data (segment, frequency, amplitude, etc.), responses from the ADF-SCI questionnaire.

IPD Sharing Time Frame

Upon completing the data collection, the data will be deposited into a public repository for SCI data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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