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

Kessler Foundation

Status: Enrolling

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

Treatments: Device: spinal cord transcutaneous stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06841198

R1287-25

Details and patient eligibility

About

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.

Full description

This clinical study investigates the cardiovascular effects of spinal cord transcutaneous stimulation (scTS) in individuals with recent spinal cord injury (SCI), examining how blood pressure response to stimulation evolves over the first year post-injury. The primary objectives are to determine the optimal timing for initiating scTS for cardiovascular control, characterize blood pressure response evolution to stimulation over one year, and assess autonomic activation patterns through multiple testing methods.

The study will recruit five individuals with recent SCI, specifically targeting those who are 50 days or less post-injury, with an injury level at or above T6, and classified as American Spinal Injury Association Impairment Scale (AIS) A/B. All participants must present with low blood pressure and orthostatic hypotension and be between 18-75 years of age.

The study protocol is divided into inpatient and outpatient phases. During the inpatient phase, consisting of 5-11 sessions, participants undergo a basic assessment including autonomic dysfunction questionnaires, 24-hour blood pressure monitoring, cold pressor testing, and tilt tests with and without stimulation. The protocol also includes 2-3 days of stimulation mapping.

The outpatient phase spans 15-18 sessions over the remainder of the year. Participants undergo monthly mapping sessions and autonomic dysfunction assessments, with comprehensive autonomic testing conducted at 6, 9, and 12 months post-injury. Throughout both phases, researchers perform stimulation mapping across various spinal segments (thoracic, lumbosacral) using a 5-channel electrical stimulator, while monitoring blood pressure and electromyography to target a blood pressure range of 110-120 mmHg.

The study employs multiple assessment tools, including 70° tilt tests with orthostatic symptom evaluation every 5 minutes, cold pressor tests, autonomic dysfunction questionnaires, and 24-hour ambulatory blood pressure monitoring.

The study aims to track primary outcomes including blood pressure response to stimulation at different time points, evolution of orthostatic hypotension symptoms and management, and the pattern of autonomic dysfunction development post-injury.

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals with a spinal cord injury undergoing inpatient rehabilitation at the Kessler Institute for Rehabilitation
• Between 18-75 years old
• 7-50 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)