TSCS for Spinal Cord Injury Blood Pressure Control

Overseen By Jill M Wecht, EdD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Jill M. Wecht, Ed.D.

Disqualifiers: Implants, Cardiac disease, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 4 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called transcutaneous spinal cord stimulation (TSCS) to help control low blood pressure in people with recent spinal cord injuries. Current treatments often fail to stabilize blood pressure during the early rehab phase after these injuries. The trial aims to determine if TSCS can safely and effectively prevent blood pressure drops when patients sit up or change positions. Suitable participants have experienced a spinal cord injury within the last year, have low or fluctuating blood pressure, and are in rehab at Mount Sinai. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could significantly improve rehabilitation outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this TSCS protocol is safe for stabilizing blood pressure in spinal cord injury patients?

Research has shown that transcutaneous spinal cord stimulation (TSCS) is generally safe for people with spinal cord injuries. One study found that using TSCS with rehabilitation did not significantly harm participants. Another small study tested TSCS in a clinical setting and found it safe and practical to use. These findings suggest that TSCS is well-tolerated, with few reports of serious side effects. Overall, the evidence indicates that TSCS is a fairly safe option for those with spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for controlling blood pressure in spinal cord injury patients involve medications that can have varied effects and may not work for everyone. In contrast, transcutaneous spinal cord stimulation (TSCS) is unique because it uses electrical stimulation applied through the skin to help stabilize blood pressure. Researchers are excited about TSCS because it offers a non-invasive approach that directly targets the spinal cord's ability to regulate blood pressure, potentially reducing the need for medication. Additionally, TSCS could improve blood pressure control when patients move from lying down to sitting up, a challenging situation for many with spinal cord injuries.

What evidence suggests that TSCS is effective for stabilizing blood pressure in spinal cord injury patients?

Research shows that transcutaneous Spinal Cord Stimulation (TSCS), the treatment participants in this trial will receive, might help stabilize blood pressure in people with spinal cord injuries. Studies have found that TSCS can increase blood pressure when sitting and prevent it from dropping during position changes, such as sitting up. This treatment affects the part of the spine that controls blood pressure. It is promising because it can improve blood pressure without harmful side effects. Although more research is needed, early results suggest TSCS could be a safe and practical method for managing blood pressure issues in people with spinal cord injuries. ^{2 5 6 7 8}

Who Is on the Research Team?

Thomas N Bryce, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for acute inpatients with a traumatic spinal cord injury (SCI) within one year of the injury, experiencing low blood pressure related issues. They must be at least 14 years old and admitted to Acute Inpatient Rehabilitation at Mount Sinai. Exclusions include heart disease, recent heart attack, cancer, certain implants like pacemakers or cochlear implants, open skin lesions near electrode sites, pregnancy, or inability to consent.

Inclusion Criteria

I am at least 14 years old.

I have a recent spinal cord injury from an accident.

I am admitted to Acute Inpatient Rehabilitation at Mount Sinai.

Exclusion Criteria

Cochlear implants

Pregnancy

I have a serious heart condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcutaneous spinal cord stimulation (TSCS) to stabilize seated systolic blood pressure and test its efficacy during orthostatic repositioning

Up to 4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of dizziness symptoms and skin changes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TSCS

Trial Overview The trial tests Transcutaneous Spinal Cord Stimulation (TSCS), a non-drug method aimed at stabilizing blood pressure after SCI. It's designed as an alternative to epidural stimulation and can be quickly turned on/off and used alongside physical exercise. The goal is to create a standard treatment algorithm for clinical use.

How Is the Trial Designed?

Group I: transcutaneous spinal stimulation Experimental Treatment 1 Intervention

Transcutaneous spinal cord stimulation (TSCS) protocol to stabilize seated systolic blood pressure in newly injured patients with spinal cord injury and to test the ability of TSCS to reduce the fall in blood pressure when these patients are moved from the supine to the seated position.

Who Is Running the Clinical Trial?

Jill M. Wecht, Ed.D.

Lead Sponsor

Trials

1

Recruited

50+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Published Research Related to This Trial

In a study of 129 patients with traumatic spinal cord injury, maintaining a mean arterial blood pressure (MABP) above 80 mm Hg during prehospital and initial hospital treatment phases was significantly correlated with better long-term neurological outcomes, as measured by the ISNCSCI score one year post-injury.

The strongest correlations for MABP and neurological outcomes were observed during prehospital transport and in the operating room, indicating that early stabilization of blood pressure is crucial for minimizing secondary spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial blood pressure is important for long-term outcome after traumatic spinal cord injury. Haldrup, M., Dyrskog, S., Thygesen, MM., et al.[2020]

Transcutaneous spinal cord stimulation (t-SCS) was tested in a feasibility study with three patients suffering from orthostatic hypotension, showing promising results in elevating blood pressure during tilt testing.

When t-SCS was applied, all patients experienced increased systemic vascular resistance and two patients had significantly higher systolic and diastolic blood pressure, suggesting that t-SCS could be a potential treatment for managing orthostatic hypotension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Spinal Cord Stimulation Attenuates Blood Pressure Drops in Orthostasis. Beliaeva, NN., Moshonkina, TR., Mamontov, OV., et al.[2023]

In a study of 258 patients treated with spinal cord stimulation (SCS) for peripheral vascular disease, limb survival rates at 18 months were 77.8% for those with low baseline oxygen levels and 89.5% for those with medium levels, indicating SCS is effective in improving limb survival.

The treatment led to a sustained increase in transcutaneous oxygen pressure (TcPO(2)) values to around 30 mm Hg, suggesting that baseline TcPO(2) levels could be a useful predictor of treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation in the treatment of peripheral vascular disease: results of a single-center study of 258 patients. Horsch, S., Schulte, S., Hess, S.[2022]

Transcutaneous spinal cord stimulation (tSCS) shows potential for generating motor activity in individuals with spinal cord injury, but the overall quality of the studies reviewed was poor-to-fair, indicating a need for more rigorous research.

The review identified significant variability in stimulation parameters and outcome measurements across the 25 studies analyzed, highlighting the necessity for standardized methods to improve the reliability and comparability of tSCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. Taylor, C., McHugh, C., Mockler, D., et al.[2022]

Transcutaneous spinal cord stimulation (tSCS) can non-invasively enhance sensorimotor rehabilitation by modulating spinal cord circuitry, showing promise for improving recovery after spinal cord injuries.

Single-site tSCS can influence excitability across multiple spinal cord segments, while multi-site tSCS can enhance spinal reflexes and corticospinal networks, indicating its potential for more effective rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. Barss, TS., Parhizi, B., Porter, J., et al.[2022]

In a study analyzing 2053 cases of cervical spinal cord stimulation (cSCS) from 2002 to 2011, the rate of spinal cord injury was found to be 0.5%, which is higher than previously reported, indicating a need for careful patient selection and counseling.

Despite the spinal cord injury rate, cSCS remains a relatively safe procedure with low rates of other complications (1.1% neurological, 1.4% medical, and 11.7% general perioperative complications), making it a viable option for pain management in patients, especially in an aging population reliant on opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. Chan, AK., Winkler, EA., Jacques, L.[2017]

Transcutaneous electrical stimulation can effectively regulate arterial pressure in patients with spinal cord injury who experience central baroreflex failure and severe orthostatic hypotension.

The developed bionic baroreflex system is a noninvasive method that successfully restores and maintains arterial pressure during orthostatic stress, demonstrating its potential as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive transcutaneous bionic baroreflex system prevents severe orthostatic hypotension in patients with spinal cord injury. Yoshida, M., Murayama, Y., Chishaki, A., et al.[2020]

In a study involving 10 normotensive subjects, thoracic spinal cord stimulation (SCS) did not significantly lower mean arterial pressure (MAP) or heart rate (HR) compared to baseline, indicating that SCS may not have a strong effect on these cardiovascular parameters in a resting state.

During a stress test (Cold Pressor Test), SCS at the T5-T6 region resulted in a significant increase in MAP, suggesting that while SCS is safe and does not cause adverse cardiovascular effects, its impact on blood pressure may vary under stress conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute cardiovascular effects of epidural spinal cord stimulation. Schultz, DM., Musley, S., Beltrand, P., et al.[2011]

In a pilot study involving 7 individuals with chronic spinal cord injury, the use of transcutaneous electrical spinal cord stimulation (TSCS) combined with functional training led to improvements in upper and lower extremity function, with all participants showing progress on the Capabilities of Upper Extremity Test (CUE-T).

Notably, two participants improved their ASIA impairment scale classification, and five individuals experienced enhanced sensation, demonstrating that TSCS can facilitate recovery even after a plateau in rehabilitation progress, without any serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. Tefertiller, C., Rozwod, M., VandeGriend, E., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10754346/

Transcutaneous Spinal Cord Stimulation to Stabilize Seated ... Electrical spinal cord stimulation (SCS) has emerged as a potentially promising treatment that improves ANS function to increase and stabilize ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1878747925000066

Cardiovascular safety of transcutaneous spinal cord ... The lack of adverse effects on blood pressure and heart rate during the intervention, together with the previously reported clinically meaningful improvements ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38156073/

Transcutaneous Spinal Cord Stimulation to Stabilize ... tSCS is an emerging therapeutic strategy to target spinal autonomic circuitry to normalize and stabilize blood pressure (BP) in hypotensive persons living with ...

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06000592

Safety, Feasibility, and Efficacy of TSCS on Stabilizing ... Recent published evidence suggests that transcutaneous Spinal Cord Stimulation (TSCS) can be used to raise seated BP, and mitigate the falls in BP during ...

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

Safety and Effectiveness of Multisite Transcutaneous ... Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating ...

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

Safety and Effectiveness of Multisite Transcutaneous ... Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548825/

Protocol for a Systematic Review and Meta-Analysis - PMC This comprehensive systematic review and meta-analysis will address an important evidence gap, providing the first focused evaluation of tSCS ...

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

Transcutaneous Electrical Spinal Cord Stimulation to ... The primary objective of this pilot study was to evaluate the safety and feasibility of using TSCS in a clinical setting to promote recovery ...