Spinal Stimulation for Cardiovascular Function After Spinal Cord Injury

Overseen By Leighann Martinez, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Ventilator, Cardiac devices, Heart disease, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

5 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Einat Engel-Haber, MD

Principal Investigator

Kessler Foundation

Eligibility Criteria

This trial is for individuals in their first year after a spinal cord injury who are experiencing low blood pressure and related cardiovascular issues. Participants will undergo treatment sessions during and after their stay at the Kessler Institute for Rehabilitation.

Inclusion Criteria

Individuals with a spinal cord injury undergoing inpatient rehabilitation at the Kessler Institute for Rehabilitation

American Spinal Injury Association Impairment Scale (AIS) A or B

My spinal injury is at chest level or higher.

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

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Phase

Participants undergo basic assessments including autonomic dysfunction questionnaires, 24-hour blood pressure monitoring, cold pressor testing, and tilt tests with and without stimulation. Includes 2-3 days of stimulation mapping.

5-11 sessions

5-11 visits (in-person)

Outpatient Phase

Participants undergo monthly mapping sessions and autonomic dysfunction assessments, with comprehensive autonomic testing at 6, 9, and 12 months post-injury.

15-18 sessions over the year

15-18 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on blood pressure response and autonomic dysfunction.

4 weeks

Treatment Details

Trial Overview The study tests how transcutaneous spinal stimulation affects blood pressure and overall cardiovascular function post-spinal cord injury. It involves around 20-29 treatment sessions over the course of a year, both inpatient and outpatient.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+