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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how spinal stimulation might improve blood pressure and heart function in individuals with recent spinal cord injuries. The researchers focus on cardiovascular health changes during the first year after injury. Participants will receive non-invasive transcutaneous spinal stimulation, which delivers a gentle electrical pulse through the skin, to determine its effectiveness in managing low blood pressure. This trial suits those who have recently experienced a spinal cord injury, are undergoing rehabilitation at the Kessler Institute, and are dealing with low blood pressure. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance future treatments for spinal cord injuries.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have started a new medication for blood pressure or heart problems in the last five days, except for midodrine.

What prior data suggests that transcutaneous spinal stimulation is safe for cardiovascular function after spinal cord injury?

Research has shown that transcutaneous spinal stimulation (TSS) is generally safe for patients. In some studies, TSS improved muscle function in people with spinal cord injuries. Participants tolerated it well, and no serious side effects were reported. These studies have not linked TSS to major negative effects, suggesting the treatment is likely safe for humans.

However, as with any new treatment, individual experiences can vary, so monitoring for any changes is important. If there are concerns, consult a healthcare provider before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcutaneous spinal stimulation is unique because it offers a non-invasive way to potentially improve cardiovascular function after a spinal cord injury. Unlike traditional treatments that primarily focus on managing symptoms through medications or physical therapy, this method directly targets the spinal cord's ability to regulate cardiovascular responses. Researchers are excited because this approach could lead to more effective management of cardiovascular issues in spinal cord injury patients by enhancing the body's natural ability to control blood pressure and heart rate.

What evidence suggests that transcutaneous spinal stimulation is effective for improving cardiovascular function after spinal cord injury?

Studies have shown that using electrical impulses on the skin, known as transcutaneous spinal stimulation, helps control blood pressure after a spinal cord injury. This treatment activates nerves, which may aid in managing blood pressure. Research indicates that this method improves blood pressure and heart rate, helping the body remain stable. Although it is not yet clear if it can fully restore natural body control, it appears to support heart and blood vessel function. Early findings suggest it could be a promising option for those facing blood pressure issues after a spinal cord injury. ^{6 7 8 9 10}

Who Is on the Research Team?

Einat Engel-Haber, MD

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Spinal Stimulation

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12014404/

Cardiovascular safety of transcutaneous spinal cord ... Epidural spinal cord stimulation (eSCS) has demonstrated promising results in promoting recovery of motor and autonomic function in individuals ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06313515

NCT06313515 | Transcutaneous Spinal Cord Stimulation ... Evaluate the effects 8 weeks of targeted tSCS paired with arm-crank exercise compared to sham stimulation with exercise on improving cardiovascular function in ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715923007146

Cardiovascular Effects of Spinal Cord Stimulation Spinal cord stimulation (SCS) has been reported to modulate blood pressure (BP), heart rate (HR), and HR variability (HRV).

4. journals.physiology.org journals.physiology.org/doi/full/10.1152/ajpheart.00588.2023?doi=10.1152/ajpheart.00588.2023

Transcutaneous spinal cord stimulation and its impact on ... Spinal cord stimulation increases blood pressure after spinal cord injury, though it is unclear if this restores natural autonomic regulation or induces a ...

5. researchprotocols.org researchprotocols.org/2025/1/e80995

Effectiveness of Transcutaneous Spinal Cord Stimulation ... Objective: This systematic review and meta-analysis will determine the effectiveness of tSCS, compared with sham stimulation, no intervention, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39998450

Safety and Effectiveness of Multisite Transcutaneous ... Objective: Evaluate the preliminary safety and efficacy of multi-site transcutaneous spinal cord stimulation (tSCS) combined with activity-based ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ... Evaluate the preliminary safety and efficacy of multi-site transcutaneous spinal cord stimulation (tSCS) combined with activity-based therapy (ABT) in ...

8. neurology.org neurology.org/doi/10.1212/WNL.0000000000205724

Transcutaneous Spinal Cord Stimulation (ARC-EX Therapy ... Clinic and home-based ARC EX Therapy is safe and effectively improves upper extremity strength and function in people living with chronic, cervical SCI.

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN240014.pdf

Transcutaneous electrical spine stimulator to improve skeletal ... The ARCEX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic ...

10. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2021.740307/full

Transcutaneous Electrical Spinal Cord Stimulation to ... TSCS is designed to modulate spinal networks through surface electrodes placed directly over the spinal cord using a unique waveform to deliver ...