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NCT Number: NCT07674511

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

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?

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Key information

Conditions

Spinal Cord Injuries Autonomic Nervous System Diseases Blood Pressure Cardiovascular Diseases Central Nervous System Disease Central Nervous System Diseases Hypotension Hypotension, Orthostatic Nervous System Diseases Orthostatic Hypotension Orthostatic Intolerance Primary Dysautonomias Spinal Cord Diseases Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location contact

Einat Engel-Haber, MD

CONTACT

[email protected]

Einat Engel-Haber, MD

SUB_INVESTIGATOR

Gail F Forrest, PhD

PRINCIPAL_INVESTIGATOR

LeighAnn Martinez, BA

CONTACT

[email protected]

(973)324-3557

Steven Kirshblum, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Persistent hypotension (SBP < 90mmHg)
  • 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

Treatment and study plan

Tilt test with stimulation (real-time effects): Intervention 1

Device

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.

20 sessions of stimulation (Intervention 2)

Device

Participants will undergo 20 separate 30-minute sessions of transcutaneous spinal cord stimulation while seated in their wheelchairs

Primary outcomes

  1. Systolic blood pressure

    Time frame: 1 month

    Evaluate changes in blood pressure during an orthostatic tilt test comparing stimulation to no stimulation.

  2. 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

Secondary outcomes

  1. 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)

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Einat Engel-Haber, MD

CONTACT

[email protected]

LeighAnn Martinez, BA

CONTACT

[email protected]

972-324-3557

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • Montclair State University

Registry information

Official study title

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

Acronym: (SCI)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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