Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury ((SCI))

June 24, 2026 updated by: Einat Haber, Kessler Foundation

Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury: Short and Long-Term Effects

The purpose of this study is to learn whether stimulation applied to the spinal cord through the skin (called transcutaneous spinal stimulation) can help control blood pressure in people with a spinal cord injury.

The main questions this study attempts to solve:

  1. What are the immediate effects of spinal cord transcutaneous stimulation on BP?
  2. Does stimulation produce lasting improvements in BP regulation and subsequently, daily function?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

We want to find out if this stimulation can help both right away (during a session) and over time (after several sessions). Specifically, this study will look at whether spinal stimulation can treat orthostatic hypotension, which is a drop in blood pressure that happens when the patient moves from lying down to sitting or standing up. To take part, one must have had a spinal cord injury for more than one year.

Study Type

Interventional

Enrollment (Estimated)

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 Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Kessler Foundation
        • Sub-Investigator:
          • Steven Kirshblum, MD
        • Principal Investigator:
          • Gail F Forrest, PhD
        • Sub-Investigator:
          • Einat Engel-Haber, MD
        • Contact:
        • Contact:

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 SCI ≥ 1 year after injury
  • Injury level ≥ T6 (thoracic level)
  • AIS grade A-C

  • Cardiovascular dysfunction characterized by one or more of the following:

    1. Persistent hypotension (SBP < 90mmHg)
    2. Orthostatic hypotension (OH, a drop of 20/10 mmHg in SBP/DBP within 5 minutes of standing/upright positioning).

Additionally, experiencing orthostatic symptoms in daily life and/or requiring medication to manage OH.

Exclusion Criteria:

  • Current illness (e.g., infection, a pressure injury that might interfere with the intervention)
  • Ventilator-dependent
  • History of implanted brain/spine/nerve stimulators
  • Cardiac pacemaker/defibrillator or intra-cardiac lines
  • Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction
  • History of seizures
  • pregnancy
  • Insufficient mental capacity to understand and independently provide consent
  • Deemed unsuitable by the study physician

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: participants with chronic SCIs.

Participation in this study will take about 5 to 6 months and will include approximately 30 to 40 separate lab visits. Most visits will last about 2 hours, though some of the early visits may take longer.

The study consists of:

  1. Baseline assessments, including a tilt test and various cardiovascular assessments
  2. Mapping stimulation sessions - several days when different stimulation parameters and locations are tested in order to obtain the configurations for the most suitable blood pressure response.
  3. Repeat tilt test, with stimulation (intervention 1), with continuous blood pressure monitoring
  4. 20 stimulation sessions, each 30-min long, with participants in their wheelchairs (intervention 2)
  5. Repeat baseline assessments
Device: Tilt test with stimulation (real-time effects): Intervention 1
While lying supine, participants will be strapped to a Hi-Low tilt-table bed. The bed will gradually be tilted to a 70 degrees tilt, during which time continuous hemodynamic measures will be recorded. This position will be maintained for 30 minutes. During tilt, transcutaneous stimulation will be applied, using the configuration that was chosen based on the mapping sessions.
Device: 20 sessions of stimulation (Intervention 2)
Participants will undergo 20 separate 30-minute sessions of transcutaneous spinal cord stimulation while seated in their wheelchairs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: 1 month
Evaluate changes in blood pressure during an orthostatic tilt test comparing stimulation to no stimulation.
1 month
Systolic blood pressure
Time Frame: Through study completion, an average of 5 months
changes in blood pressure drop with tilt (no stimulation) from baseline testing to tilt test (no stimulation) after 20 sessions of stimulation
Through study completion, an average of 5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration in tilt test
Time Frame: Through study completion, an average of 5 months
how long the participant was able to stay in an orthostatic provocation (70 degrees tilt in tilt table)
Through study completion, an average of 5 months
Orthostatic symptoms questionnaire
Time Frame: Through study completion, an average of 5 months
A designated questionnaire evaluates symptoms such as headaches, dizziness, blurred vision, nausea, weakness, confusion, fatigue, ringing in the ears, and feeling of passing out. Recorded every 5 minutes (or sooner if symptoms worsen). Participants rate each symptom on a scale of 0 to 10, with 10 indicating the highest severity.
Through study completion, an average of 5 months
24-hour ABPM OH events - taken at home
Time Frame: Through study completion, an average of 5 months
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. Conducted before, halfway through, and after the intervention
Through study completion, an average of 5 months
Autonomic Dysfunction Following Spinal Cord Injury questionnaire scores
Time Frame: Through study completion, an average of 5 months
24-item self-reported tool designed for clinical practice and research to assess symptoms of BP instability. It evaluates the frequency and severity of symptoms during high and low BP events
Through study completion, an average of 5 months
Spinal cord injury - quality of life scores
Time Frame: Through study completion, an average of 5 months
A questionnaire was developed to address the shortage of psychometrically sound and relevant patient-reported outcome measures for clinical care and research in SCI rehabilitation
Through study completion, an average of 5 months
Canadian Occupational Performance Measure scores
Time Frame: Through study completion, an average of 5 months
A semi-structure interview where the individual identifies and measures their areas of difficulty, scoring their performance on the tasks and their satisfaction with their ability
Through study completion, an average of 5 months

Collaborators and Investigators

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

Sponsor

Kessler Foundation

Collaborators

Montclair State University

Investigators

  • Principal Investigator: Gail F Forrest, PhD, Kessler Foundation

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 (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

June 12, 2026

First Submitted That Met QC Criteria

June 24, 2026

First Posted (Actual)

June 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-1323-26
  • 1R03HD120505-01 (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

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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