Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury

NCT06841198 | Recruiting

• 1 other identifier: R1287-25
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to explore how cardiovascular function changes in the first year after a spinal cord injury, and to see how different treatments, like spinal stimulation through the skin (transcutaneous spinal stimulation), affect blood pressure. The main questions are: How does stimulation affect blood pressure over the year? What is the level of cardiovascular activation throughout the year? The study will start during the inpatient stay at the Kessler Institute for Rehabilitation and continue after discharge as an outpatient, totaling about 20-29 sessions over the year.

Conditions

Spinal Cord Injuries (SCI); Orthostatic Hypotension, Dysautonomic; Cardiovascular; Transcutaneous Spinal Stimulation

Keywords

Transcutaneous Spinal Cord Stimulation; spinal cord stimulation; orthostatic hypotension; blood pressure; cardiovascular; neuromodulation; acute spinal cord injury; chronic spinal cord injury; inpatient rehabilitation; tilt testing; cold pressor test; ambulatory blood pressure monitoring; autonomic dysfunction following spinal cord injury

Outcome Measures

Primary Outcomes (2)

• Systolic blood pressure in seated mapping sessions

  Spatiotemporal mapping sessions involving stimulation of various spinal segments, utilizing different parameters (e.g., frequency, waveform). A BP response in a mapping session will be defined by a significant increase in SBP of at least 20 mmHg with stimulation compared to baseline SBP (without stimulation)

  The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.

• systolic blood pressure in a 70 degree tilt

  In this study, tilt-tests are conducted in pairs: first, a standard tilt test (without stimulation), followed by a tilt test with stimulation aimed at preventing orthostatic hypotension. We will compare the drop in systolic blood pressure during the tilt test with stimulation to the drop observed in the standard tilt test.

  The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately every three months

Secondary Outcomes (3)

• cold pressor test

  The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately every three months

• 24-hour ambulatory blood pressure monitoring

  The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.

• An autonomic dysfunction following spinal cord injury questionnaire

  The procedure will be repeated throughout the year, starting shortly after the injury and occurring approximately once a month.

Other Outcomes (2)

• Blood pressure changes during ice testing (spin-off experiment)

  From enrollment to the end of the second session at 1 month

• Pain response to ice testing (spin-off experiment)

  From enrollment to the end of the second session at 1 month

Study Arms (2)

Testing position and cooling modality for the ice test

OTHER

As a spin-off of the main study, we aim to determine which cooling modality and body position elicit the most consistent and stable blood pressure response. To do so, we conduct a supplementary experiment involving 5 individuals with chronic SCI and 5 able-bodied controls. Each participant completes two experimental sessions: one in the supine position and one in the seated position. Within each session, participants undergo two tests, separated by a 30-minute rest period: 1. an ice-water immersion test, in which the foot is submerged in ice water for 3 minutes, and 2. an ice-wrap test, in which ice packs are applied around the foot and ankle for 3 minutes. The order of body position and cooling modality is pseudo-randomized. Throughout each test, blood pressure is continuously recorded, and participants rate discomfort or pain at 1-minute intervals.

Procedure: Ice testing

Main study: assessing the BP changes throughout the first year post SCI

OTHER

The main study recruits 5 individuals with sub-acute SCI and follows them for one year to evaluate how blood pressure responses evolve during the early post-injury period.

Device: spinal cord transcutaneous stimulation

Interventions

spinal cord transcutaneous stimulation DEVICE

Stimulation, using the Neostim-5 (Cosyma Ltd.), a 5-channel electrical stimulator, will be administered throughout the study period, beginning shortly after the injury and continuing at regular intervals until one year post-spinal cord injury. It will be performed in two settings: 1. During seated mapping to identify stimulation sites (potentially T7/8, T11/12, L1/2, and S1/2) and determine stimulation parameters (e.g., frequency, pulse wave, amplitude) that elevate systolic blood pressure (SBP) and maintain it within the target range of 110-120 mmHg. 2. During 70-degree tilt tests to elicit an orthostatic response (a drop in blood pressure accompanied by symptoms).

Main study: assessing the BP changes throughout the first year post SCI

Ice testing PROCEDURE

Ice testing is performed using either a 3-minute ice-water immersion or a 3-minute ice-wrap application surrounding the foot. Each participant undergoes both the ice-water and ice-wrap conditions within the same session, separated by a 30-minute interval to allow the foot to return to baseline. Testing is conducted in both the seated and supine positions across two separate sessions, with both the cooling modality and body position randomized.

Testing position and cooling modality for the ice test

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with a spinal cord injury undergoing inpatient rehabilitation at the Kessler Institute for Rehabilitation
• Between 18-75 years old
• days after injury
• Injury level ≥ T6 (a cervical or a high-level chest injury)
• Individuals experiencing low blood pressure after the injury
• American Spinal Injury Association Impairment Scale (AIS) A or B

You may not qualify if:

• A ventilator is needed for breathing.
• Devices such as brain/spine/nerve stimulators, a cardiac pacemaker/defibrillator, or intra-cardiac lines are present in the body.
• There is a significant disease affecting the blood vessels or signals in the heart, or a recent heart attack (myocardial infarction) has occurred.
• A new medication has been prescribed to treat blood pressure or a heart problem within the last five days (excluding midodrine).
• There is a known infection in the body (e.g., urinary tract infection) or a current illness (e.g., recent diagnosis of deep vein thrombosis (DVT) or other blood clotting issues, and/or a pressure injury that might interfere with the study).
• There is a history of seizures.
• Pregnancy.
• For the spin-off study ice-water vs ice-wrap test (see description in study arms):
• \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
• Age 18-75.
• Injury sustained more than 6 months ago
• Injury level ≥ T6 (a cervical or a high-level chest injury)
• American spinal injury association impairment scale (AIS) A - D
• Foot lesions, uses a ventilator, devices such as brain/spine/nerve stimulators, significant or recent cardiovascular disease, known infection in the body

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

Related Publications (1)

• Engel-Haber E, Bheemreddy A, Bayram MB, Ravi M, Zhang F, Su H, Kirshblum S, Forrest GF. Neuromodulation in Spinal Cord Injury Using Transcutaneous Spinal Stimulation-Mapping for a Blood Pressure Response: A Case Series. Neurotrauma Rep. 2024 Sep 20;5(1):845-856. doi: 10.1089/neur.2024.0066. eCollection 2024.

  PMID: 39391052 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Shy-Drager Syndrome; Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Multiple System Atrophy; Primary Dysautonomias; Autonomic Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Movement Disorders; Hypotension; Vascular Diseases; Cardiovascular Diseases; Orthostatic Intolerance

Study Officials

• Einat Engel-Haber, MD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leighann Martinez, BA

CONTACT

(973)324-3557; lmartinez@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: February 18, 2025
• First Posted: February 24, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 1, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon completing the data collection, the data will be deposited into a public repository for SCI data

Locations

US (1)