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

NCT05731986 | Recruiting

• 1 other identifier: CSCR23FEL002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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. 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. 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?

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 2 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 2 weeks

• Systolic blood pressure measurements (mmHg) - Mean and SD of beat-to-beat BP

  A comparison of systolic blood pressure with no stimulation, sham or optimal stimulation during an orthostatic challenge will be performed to assess the efficacy of stimulation.

  Throughout the experiment, average of 2 weeks

• Change in Orthostatic symptoms when stimulation is applied

  A questionnaire ranking the severity of orthostatic symptoms (dizziness, nausea), using a scale of 1-10 (10 being the most severe), will be conducted during an orthostatic test to assess the efficacy of stimulation and compare the effects of optimal and sham stimulation.

  Will be performed every 5 minutes during the orthostatic tests, average of 2 weeks

Secondary Outcomes (8)

• Numeric Rating Scale (NRS) for pain

  Throughout the experiment, average of 2 weeks

• Skin integrity assessment

  Throughout the experiment, average of 2 weeks

• Feasibility of applying scTS in inpatient settings - compliance

  Throughout the experiment, average of 2 weeks

• Feasibility of applying scTS in inpatient settings - session duration

  Throughout the experiment, average of 2 weeks

• Feasibility of applying scTS in inpatient settings - effect on therapy

  Throughout the experiment, average of 2 weeks

Study Arms (2)

Optimal stimulation (for a blood pressure response)

ACTIVE COMPARATOR

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.

Diagnostic Test: Orthostatic challenge; Device: Biostim-5 transcutaneous spinal stimulation - Mapping; Device: Biostim-5 transcutaneous spinal stimulation - "Optimal" testing

Sham stimulation

SHAM COMPARATOR

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.

Diagnostic Test: Orthostatic challenge; Device: Biostim-5 transcutaneous spinal stimulation - Mapping; Device: Biostim-5 transcutaneous spinal stimulation - "Sham" testing

Interventions

Orthostatic challenge DIAGNOSTIC_TEST

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.

Also known as: Sit-up test

Optimal stimulation (for a blood pressure response); Sham stimulation

Biostim-5 transcutaneous spinal stimulation - Mapping DEVICE

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.

Optimal stimulation (for a blood pressure response); Sham stimulation

Biostim-5 transcutaneous spinal stimulation - "Optimal" testing DEVICE

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).

Optimal stimulation (for a blood pressure response)

Biostim-5 transcutaneous spinal stimulation - "Sham" testing DEVICE

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

Sham stimulation

Eligibility Criteria

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

You may qualify if:

• 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:
• Baseline hypotension - resting supine or seated 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 (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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Diseases; Trauma, Nervous System; Nervous System Diseases; Central Nervous System Diseases; Hypotension; Hypotension, Orthostatic; Cardiovascular 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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: During the two testing days, participants will be blinded to the order of the stimulation. One testing day will include an orthostatic sit-up test with optimal stimulation (for a blood pressure response), while the other will include a sit-up test with sham stimulation
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scientist

Model Details: Twelve individuals admitted to inpatient rehabilitation after sustaining a spinal cord injury will be enrolled. They will complete baseline assessments including an orthostatic sit-up test and neurophysiological mapping. Subsequently, the intervention will consist of two days of stimulation mapping to locate the optimal spinal segment for a blood pressure response. Participants will then be randomly assigned to two groups that would determine the order of the two testing days (optimal/sham), where stimulation is applied during an orthostatic test.

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 16, 2023
• Study Start: December 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)