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

NCT ID: NCT05731986

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2026-08-31

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.

Detailed Description

Blood pressure (BP) control in persons with a spinal cord injury (SCI) is often impaired, resulting in short and long-term health complications and a decline in quality of life. Cardiovascular (CV) dysfunction develops early after SCI and often continues a lifetime. Orthostatic hypotension (OH), a 20/10 mmHg decrease in systolic/diastolic BP when moving from a supine to an upright position, is especially prevalent in the early phase, and frequently accompanied by symptoms of dizziness, weakness, fatigue, and syncope. Affecting up to 75% of therapy treatments during inpatient rehabilitation, OH significantly interferes with participation during the critical rehab time-period, especially as length of stay in rehabilitation has substantially shortened in the past decades.

The compelling rationale for early identification and treatment of OH is met by several pharmacological and non-pharmacological interventions, however, the majority have limited effect, and increase the risk of adverse drug effects due to polypharmacy. In recent years, epidural and transcutaneous spinal cord stimulation has been explored with promising results as a potential treatment to CV dysfunction in SCI. To date, only individuals with a chronic SCI (>1 year) were included in these studies.

The objective of this study is to investigate the effect of spinal cord transcutaneous stimulation (scTS) on BP in individuals with an acute/sub-acute SCI (7-30 days after injury), during their inpatient rehabilitation. Optimal stimulation sites and parameters that increase and stabilize systolic BP (SBP) within the normotensive range (110-120 mmHg) during an orthostatic challenge will be sought. In this crossover randomized controlled trial (RCT), the effect of optimal CV stimulation and sham stimulation on BP and orthostatic symptoms will be assessed and compared.

The information gleaned from this work will allow design and implementation of scTS interventions in the early phase following an SCI, allowing full participation in inpatient rehabilitation programs, which are often hindered by the patients' autonomic dysfunction.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Orthostatic challenge

Intervention Type: 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.

Biostim-5 transcutaneous spinal stimulation - Mapping

Intervention Type: 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.

Biostim-5 transcutaneous spinal stimulation - "Optimal" testing

Intervention Type: 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).

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.

Group Type: SHAM_COMPARATOR

Orthostatic challenge

Intervention Type: 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.

Biostim-5 transcutaneous spinal stimulation - Mapping

Intervention Type: 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.

Biostim-5 transcutaneous spinal stimulation - "Sham" testing

Intervention Type: DEVICE

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

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DEVICE

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).

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

Sit-up test

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Einat Haber

Associate Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gail F Forrest, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

Kessler Foundation

West Orange, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

LeighAnn Martinez, BA

Role: CONTACT

lmartinez@kesslerfoundation.org

(973)324-3557

Einat Engel-Haber, MD

Role: CONTACT

ehaber@kesslerfoundation.org

Facility Contacts

LeighAnn Martinez, BA

Role: primary

lmartinez@kesslerfoundation.org

973-324-3557

Einat Engel-Haber, MD

Role: backup

ehaber@kesslerfoundation.org

Other Identifiers

CSCR23FEL002

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CSCR23FEL002

Identifier Type: -

Identifier Source: org_study_id