Recruiting

Transcutaneous Stimulation

Sponsor:

Kessler Foundation

Code:

NCT05731986

Conditions

Spinal Cord Injuries

Spinal Cord Diseases

Trauma, Nervous System

Nervous System Diseases

Central Nervous System Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Orthostatic challenge

Biostim-5 transcutaneous spinal stimulation - Mapping

Biostim-5 transcutaneous spinal stimulation - "Optimal" testing

Biostim-5 transcutaneous spinal stimulation - "Sham" testing

Study Details

Brief summary:

The goal of this clinical trial is to evaluate the effect of transcutaneous spinal cord stimulation on blood pressure in individuals with an acute spinal cord injury (within 30 days of injury). Blood pressure instability, specifically orthostatic hypotension (a drop in blood pressure when moving lying flat on your back to an upright position), appears early after the injury and often significantly interferes with participation in the critical rehabilitation time period.

The main questions it aims to answer are:

1. Can optimal spinal stimulation increase blood pressure and resolve orthostatic symptoms (such as dizziness and nausea) when individuals undergo an orthostatic provocation (a sit-up test)? Optimal stimulation and sham stimulation (which is similar to a placebo treatment) will be compared.
2. What are the various spinal sites and stimulation parameters that can be used to increase and stabilize blood pressure to the normal range of 110-120 mmHg?

Participants will undergo orthostatic tests (lying on a bed that starts out flat and then moved into an upright seated position by raising the head of bed by 90° and dropping the base of the bed by 90° from the knee) with optimal and sham stimulation, and their blood pressure measurements will be evaluated and compared.

Conditions

Spinal Cord Injuries

Spinal Cord Diseases

Trauma, Nervous System

Nervous System Diseases

Central Nervous System Diseases

Study ID

NCT05731986

Start date

Dec 1, 2023

Status verified date

Aug, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 7-30 days after injury
  • Injury level ≥T2 (thoracic level)
  • American Spinal Injury Association Impairment Scale (AIS) A-C
  • Exhibits at least one of the following hypotensive symptoms:

1. Baseline hypotension - resting supine or seated SBP < 90mmHg;
2. SBP drop ≥ 20 mmHg within 5 minutes of assuming seated position;
3. Symptoms of orthostasis with a drop of SBP (<90mmHg) from supine to sitting.

Exclusion Criteria:

  • Current illness (e.g., a recent diagnosis of a deep vein thrombosis (DVT) or pulmonary embolism (PE), a pressure injury that might interfere with the intervention, etc.) or infection
  • 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
  • Initiated on new cardiac medications within the past 5 days
  • Insufficient mental capacity to understand and independently provide consent
  • Pregnancy
  • Cancer
  • Deemed unsuitable by study physician

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Optimal stimulation (for a blood pressure response)

Stimulation will be applied during an orthostatic sit-up challenge, using the profile (stimulation site and parameters) that was chosen in the mapping sessions, for optimal modulation of systolic blood pressure.

sham comparator: Sham stimulation

Sham stimulation will be applied during an orthostatic sit-up challenge. Sham stimulation will be delivered at a predetermined spinal location. Stimulation parameters, however, will be different from those chosen for the optimal stimulation, and sensation may be different as well.

Interventions

Orthostatic challenge

Designed to invoke an orthostatic response. It begins with the participants lying supine on a specialized bed. The bed is then converted into a chair by raising the head of the bed by 90° and dropping the base of the bed by 90° from the knee.

This position will be maintained for 15 minutes, while hemodynamic measures are continuously recorded. Some of these sessions will be accompanied by spinal stimulation.

Biostim-5 transcutaneous spinal stimulation - Mapping

Transcutaneous stimulation of the spinal cord. Two days of mapping will be performed to determine sites for modulation of blood pressure. During each day, with the participant in a supine or seated position, electrodes will be placed on the midline of one of the following spinous processes: C3/4, C5/6, C7/T1, T7/8, T11/12, L1/2 and S1/2. Stimulation intensity will start at 5 mA and gradually increase by 5 mA increments up to 100 mA. The frequency will be two or 30 Hz.

Biostim-5 transcutaneous spinal stimulation - "Optimal" testing

Based on the mapping sessions, profiles will be established to guide the selection of an optimal site location for blood pressure modulation (within the range of 110-120 mmHg).

Biostim-5 transcutaneous spinal stimulation - "Sham" testing

Based on the mapping sessions, a profile that does not elicit a significant blood pressure response, will be used for the sham stimulation.

Primary outcome measure

  • Optimal stimulation sites [ Time Frame: Through Mapping and testing sessions, average of 2 weeks ]
  • Optimal stimulation frequency [ Time Frame: Through Mapping and testing sessions, average of 2 weeks ]
  • Systolic blood pressure measurements (mmHg) - Mean and SD of beat-to-beat BP [ Time Frame: Throughout the experiment, average of 2 weeks ]
  • Change in Orthostatic symptoms when stimulation is applied [ Time Frame: Will be performed every 5 minutes during the orthostatic tests, average of 2 weeks ]

Central Contacts and Locations

Central contacts

LeighAnn Martinez, BA

(973)324-3557lmartinez@kesslerfoundation.org

Einat Engel-Haber, MD

ehaber@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

LeighAnn Martinez, BA

973-324-3557lmartinez@kesslerfoundation.org

Einat Engel-Haber, MD

ehaber@kesslerfoundation.org

Principal Investigator:

Gail F Forrest, PhD

More Information

Sponsor

Kessler Foundation

Last update posted

Sep 2, 2025

Last verified

Aug, 2025

Keywords

  • Transcutaneous Spinal Cord Stimulation
  • Spinal stimulation
  • Orthostatic Hypotension
  • Blood Pressure
  • Neuromodulation
  • Acute spinal cord injury
  • Hypotension
  • Acute inpatient rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2025-09-02.