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

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.

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

Interventions

DIAGNOSTIC_TEST

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.

DEVICE

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.

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).

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.

Sponsors & Collaborators

• Kessler Foundation

  lead OTHER

Principal Investigators

• Gail F Forrest, PhD · Kessler Foundation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-01

Primary Completion

2026-08-31

Completion

2026-08-31

Countries

• United States

Study Locations