The Effect of Transcutaneous Stimulation on Blood Pressure in Spinal Cord Injury (SCI)

NCT05725499 | Recruiting

• 2 other identifiers: R.1197.22PC8-23
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Spinal Cord Injuries; Hypotension; Orthostatic Hypotension; Spinal Cord Diseases; Cardiovascular Diseases; Trauma, Nervous System; Central Nervous System Diseases; Nervous System Diseases; Blood Pressure

Keywords

Transcutaneous Spinal Cord Stimulation; Spinal Stimulation; Orthostatic Hypotension; Blood Pressure; Neuromodulation

Outcome Measures

Primary Outcomes (5)

• Optimal stimulation sites

  Identify scTS spinal segments that restore systolic BP within the normotensive range (110-120 mmHg).

  Through Mapping and testing sessions, average of 3 weeks

• Optimal stimulation frequency

  Identify scTS frequency that restores systolic BP within the normotensive range (110-120 mmHg).

  Through Mapping and testing sessions, average of 3 weeks

• Systolic blood pressure - efficacy of stimulation

  Evaluate changes in blood pressure during an orthostatic test (comparing measurements obtained during stimulation to those obtained without). The ability of scTS to normalize SBP (to the range of 110-120) and to stabilize it over the course of a 30-min tilt test will be assessed.

  Throughout the experiment, average of 6 weeks

• Systolic blood pressure - effect of training

  Explore the blood pressure response to orthostatic stress with and without stimulation, following six days of repetitive 30-min customized scTS sessions

  Post training, average of 2 weeks

• Orthostatic symptoms questionnaire

  A questionnaire ranking the severity of orthostatic symptoms (dizziness, nausea), with a scale of 1-10 (10 being the most severe).

  Throughout the experiment, average of 6 weeks

Secondary Outcomes (5)

• EMG of leg muscles - muscle activation (analysis of mean and peak amplitudes)

  Through Mapping and testing sessions, average of 3 weeks

• Spinal Cord Injury-Quality of Life (SCI-QOL) questionnaires

  Before the first session and after the last session, average of 6 weeks

• Global response assessment (GRA)

  post training, average of 6 weeks

• Additional hemodynamic measure - diastolic blood pressure

  throughout the trial, average of 6 weeks

• Additional hemodynamic measure - heart rate

  throughout the trial, average of 6 weeks

Study Arms (1)

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

EXPERIMENTAL

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)

Device: Biostim-5 transcutaneous spinal stimulator; Diagnostic Test: Tilt-table orthostatic stress testing

Interventions

Biostim-5 transcutaneous spinal stimulator DEVICE

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.

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

Tilt-table orthostatic stress testing DIAGNOSTIC_TEST

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.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Baseline hypotension - resting supine or seated systolic blood pressure(SBP) \< 90mmHg;
• SBP drop ≥ 20 mmHg within 5 minutes of assuming seated position;
• Symptoms of orthostasis with a drop of SBP (\<90mmHg) from supine to sitting

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Hypotension; Hypotension, Orthostatic; Spinal Cord Diseases; Cardiovascular Diseases; Trauma, Nervous System; Central Nervous System Diseases; Nervous System Diseases

Condition Hierarchy (Ancestors)

Wounds and Injuries; Vascular Diseases; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases

Study Officials

• Gail F Forrest, Phd

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LeighAnn Martinez, BA

CONTACT

(973)324-3557; lmartinez@kesslerfoundation.org

Einat Engel-Haber, MD

CONTACT

ehaber@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scientist

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 13, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)