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

Trial Summary

What is the purpose of this trial?

Current forms of pharmacologic and non-pharmacologic treatments for hypotension and orthostatic hypotension (OH) remain inadequate during acute inpatient rehabilitation (AIR) following a traumatic spinal cord injury (SCI). A critical need exists for the identification of safe, practical, and effective treatment options that stabilize blood pressure (BP) after traumatic SCI. Recent published evidence suggests that transcutaneous Spinal Cord Stimulation (TSCS) can be used to raise seated BP, and mitigate the falls in BP during orthostatic repositioning in individuals with chronic SCI. This site-specific project will focus on the use of TSCS to stabilizing seated BP and mitigate the fall in BP during orthostatic repositioning during AIR following traumatic SCI.

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 data supports the effectiveness of the treatment TSCS for controlling blood pressure in patients with spinal cord injury?

Research shows that transcutaneous spinal cord stimulation (TSCS) can help stabilize blood pressure in people with spinal cord injuries. In a small study, TSCS was found to prevent significant blood pressure drops in patients with orthostatic hypotension (a condition where blood pressure falls when standing up), suggesting it may be effective for blood pressure control. ^{1 2 3 4 5}

Is transcutaneous spinal cord stimulation (tSCS) safe for humans?

Transcutaneous spinal cord stimulation (tSCS) has been shown to be relatively safe in studies, with low rates of complications. For example, a study on cervical spinal cord stimulation (a similar procedure) reported a 0.5% rate of spinal cord injury and no deaths, indicating that tSCS is generally safe for humans. ^{1 2 6 7 8}

How is the treatment TSCS different from other treatments for spinal cord injury blood pressure control?

Transcutaneous Spinal Cord Stimulation (TSCS) is unique because it is a non-invasive treatment that uses electrodes on the skin to stimulate the spinal cord, helping to control blood pressure in people with spinal cord injuries. Unlike other treatments, TSCS can modulate spinal cord activity without surgery, potentially improving blood pressure stability and sensorimotor recovery. ^{1 2 4 5 9}

Research Team

Thomas N Bryce, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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 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]

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]

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 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]

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]

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) 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Transcutaneous Spinal Cord Stimulation Attenuates Blood Pressure Drops in Orthostasis. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Acute cardiovascular effects of epidural spinal cord stimulation. [2011]

5. United States pubmed.ncbi.nlm.nih.gov

Noninvasive transcutaneous bionic baroreflex system prevents severe orthostatic hypotension in patients with spinal cord injury. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Initial blood pressure is important for long-term outcome after traumatic spinal cord injury. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. [2022]