Recruiting

Transcutaneous Stimulation

Sponsor:

Kessler Foundation

Code:

NCT05725499

Conditions

Spinal Cord Injuries

Hypotension

Orthostatic Hypotension

Spinal Cord Diseases

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Biostim-5 transcutaneous spinal stimulator

Tilt-table orthostatic stress testing

Study Details

Brief summary:

This project will investigate the effect of spinal cord transcutaneous stimulation on blood pressure in individuals with a chronic spinal cord injury who experience blood pressure instability, specifically, orthostatic hypotension (a drop in blood pressure when moving from lying flat on your back to an upright position).

The main questions it aims to answer are:

1. What are the various spinal sites and stimulation parameters that normalize and stabilize blood pressure during an orthostatic provocation (70 degrees tilt)?
2. Does training, i.e., exposure to repeated stimulation sessions, have an effect on blood pressure stability?

Participants will undergo orthostatic tests (lying on a table that starts out flat, then tilts upward up to 70 degrees), with and without stimulation, and changes in their blood pressure will be evaluated.

Conditions

Spinal Cord Injuries

Hypotension

Orthostatic Hypotension

Spinal Cord Diseases

Cardiovascular Diseases

Study ID

NCT05725499

Start date

Feb 1, 2023

Status verified date

Aug, 2025

Completion date

Aug 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Spinal cord injury for greater than or equal to 6 months
  • Injury level ≥ T6 (thoracic level)
  • American Spinal Injury Association (ASIA) Impairment Scale (AIS) A-D
  • Exhibits at least one of the following hypotensive symptoms:

1. Baseline hypotension - resting supine or seated systolic blood pressure(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 (infection, a pressure injury that might interfere with the intervention, a recent diagnosis of DVT/PE, etc.)
  • 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
  • Insufficient mental capacity to understand and independently provide consent
  • Pregnancy
  • Cancer
  • Deemed unsuitable by study physician

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants with a chronic SCI (≥ 6 months after injury)

Participants will complete three days of baseline assessments (including a baseline orthostatic test and a day of neurophysiological mapping), five days of stimulation mapping to locate the optimal spinal sites for a blood pressure response, a day of testing with stimulation applied during an orthostatic provocation and a two-week (total of six days) training period with repeated exposure to stimulation, followed by two days of additional orthostatic tests (with and without stimulation)

Interventions

Biostim-5 transcutaneous spinal stimulator

Transcutaneous stimulation of the spinal cord. Mapping will be performed to determine sites for optimal modulation of blood pressure. During each mapping day, with participants in a supine or seated position, electrodes will be placed on the midline of one of the following spinous processes: C5/6, T7/8, T11/12, L1/2 and S1/2. Stimulation intensity will start at 5 mA and gradually increased in 5 mA increments up to 100 mA. The frequency will be 2 or 30 Hz. Profiles will be established to guide selection of optimal site locations for blood pressure modulation. The profile chosen will be used during training and testing.

During testing, stimulation will be applied using the selected profile in order to normalize SBP to the range of 110-120 mmHg and stabilize it within this range during a 30-min tilt test.

On each session during the 2-week training-period, stimulation will be applied for 30 minutes using the selected profile, while the participant remains in a seated position.

Tilt-table orthostatic stress testing

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 some of the sessions, the tilt test will be accompanied by spinal stimulation.

Primary outcome measure

  • Optimal stimulation sites [ Time Frame: Through Mapping and testing sessions, average of 3 weeks ]
  • Optimal stimulation frequency [ Time Frame: Through Mapping and testing sessions, average of 3 weeks ]
  • Systolic blood pressure - efficacy of stimulation [ Time Frame: Throughout the experiment, average of 6 weeks ]
  • Systolic blood pressure - effect of training [ Time Frame: Post training, average of 2 weeks ]
  • Orthostatic symptoms questionnaire [ Time Frame: Throughout the experiment, average of 6 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

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.