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

Part of paid clinical trials in West Orange, New Jersey.

Sponsor
Kessler Foundation
Study ID
NCT05731986
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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).
  • 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.

Study Details

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.

Key Dates

Start date
Dec 1, 2023
Status verified
Aug 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Sham Comparator: 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.

Primary Outcome Measure

Optimal stimulation sites [ Time Frame: Through Mapping and testing sessions, average of 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kessler FoundationWest OrangeNew Jersey07052
LeighAnn Martinez, BA
[email protected]
973-324-3557
Einat Engel-Haber, MD
[email protected]
Gail F Forrest, PhD (PRINCIPAL_INVESTIGATOR)
Steven Kirshblum, MD (SUB_INVESTIGATOR)
Einat Engel-Haber, MD (SUB_INVESTIGATOR)
Brittany Snider, DO (SUB_INVESTIGATOR)

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Kessler Foundation· West Orange, NJ

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