TSCS for Spinal Cord Injury

Overseen By Genevieve Curtis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Implanted stimulators, Coronary disease, Cancer, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage blood pressure in individuals with recent spinal cord injuries. Such injuries can cause blood pressure to fluctuate, complicating rehabilitation. The trial employs transcutaneous spinal cord stimulation (tSCS), a non-drug technique that stimulates the spinal cord through the skin, to stabilize blood pressure. Individuals who sustained a spinal cord injury within the past 30 days to 6 months and experience blood pressure issues during rehab may qualify. Participants should not rely on a ventilator and must not have certain devices or heart conditions. As an unphased trial, this study provides a unique opportunity to investigate innovative treatment options for improved 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. However, since the study focuses on a non-drug approach to stabilize blood pressure, it might not require changes to your medication regimen. It's best to discuss this with the study team or your doctor.

What prior data suggests that Transcutaneous Spinal Cord Stimulation is safe for stabilizing blood pressure in spinal cord injury patients?

A previous study found transcutaneous spinal cord stimulation (TSCS) safe for people with spinal cord injuries. Researchers observed no major side effects when using TSCS to improve arm and hand movement. Another study on TSCS's safety and practicality showed that participants generally tolerated it well. While minor skin irritation can occur, serious issues are rare.

TSCS is non-invasive, meaning it doesn't require surgery, which lowers the risk. It is also easy to switch on and off, enhancing its safety. Current research focuses on confirming that TSCS is a practical and safe method to help stabilize blood pressure in patients with spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcutaneous spinal cord stimulation (TSCS) is unique because it offers a non-invasive approach to aid recovery from spinal cord injuries. Unlike traditional treatments such as surgery or medication, TSCS uses electrical currents applied through the skin to stimulate the spinal cord. This method is exciting for researchers because it has the potential to enhance neural recovery and improve motor function without the need for invasive procedures. By directly targeting the spinal cord, TSCS may offer quicker and more effective rehabilitation outcomes for patients with acute spinal cord injuries.

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

Research has shown that transcutaneous spinal cord stimulation (TSCS) could benefit people with spinal cord injuries. Studies have found that TSCS can improve movement and walking ability. In this trial, participants will receive TSCS as part of their rehabilitation after acute traumatic spinal cord injury. For those with long-term spinal cord injuries, combining TSCS with physical therapy has led to better recovery, especially for those who had many sessions. Another study found that using TSCS with robotic training improved leg and walking function after 20 sessions. These findings suggest that TSCS might also help maintain stable blood pressure during rehabilitation by activating the spinal cord without surgery. ^{1 2 4 5 6}

Who Is on the Research Team?

Jill Wecht, EdD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had a spinal cord injury (SCI) within the last year and are in acute inpatient rehab. They should have unstable blood pressure due to their SCI, but can't join if they're pregnant, lack mental capacity for consent, have certain implants or heart issues, open skin lesions where electrodes go, or recent heart attacks.

Inclusion Criteria

You have low blood pressure when resting or when standing up, or your blood pressure changes a lot during the day.

I am over 18, had a spinal cord injury within the last year, and am in a special rehab program.

All patients who are admitted with a new spinal cord injury during the 42-month recruitment period.

Exclusion Criteria

I am unable to understand and consent to the trial on my own.

Pregnancy

Deemed unsuitable by study physician

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 blood pressure during inpatient rehabilitation

3 weeks

Weekly visits until discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous spinal cord stimulation

Trial Overview The study tests Transcutaneous Spinal Cord Stimulation (TSCS) as a way to stabilize blood pressure during early rehab after an SCI. It aims to find the best settings for TSCS that work well with physical exercises without adding more drugs into patients' routines.

How Is the Trial Designed?

Group I: Acute Inpatients With Spinal Cord Injury Experimental Treatment 2 Interventions

Inpatient participants undergoing rehabilitation after acute traumatic SCI.

Transcutaneous spinal cord stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Transcutaneous Spinal Cord Stimulation for:

• Motor rehabilitation in individuals with spinal cord injury
• Pain management in chronic neuropathic or ischemic pain

Approved in European Union as Transcutaneous Spinal Cord Stimulation for:

• Motor rehabilitation in individuals with spinal cord injury
• Pain management in chronic neuropathic or ischemic pain

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

James J. Peters Veterans Affairs Medical Center

Collaborator

Trials

59

Recruited

2,900+

Published Research Related to This Trial

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]

Transcutaneous spinal cord stimulation (tSCS) can enhance muscle recruitment selectivity when using multielectrode configurations, as shown in a study with 16 participants, which may improve rehabilitation outcomes for paralyzed muscles after spinal cord injury.

The study found that spatially selective tSCS activates specific motor neurons through proprioceptive fibers, indicating a mechanism that could lead to more effective rehabilitation protocols targeting single-joint movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced selectivity of transcutaneous spinal cord stimulation by multielectrode configuration. Bryson, N., Lombardi, L., Hawthorn, R., et al.[2023]

In a study of 8326 patients who underwent spinal cord stimulation (SCS) implantation, the overall incidence of spinal cord injury (SCI) was found to be low at 2.13%, indicating that SCS is a generally safe procedure.

There was no significant difference in the rates of SCI or spinal hematoma between patients receiving percutaneous (2.35%) and paddle (1.71%) electrode implantation, suggesting similar safety profiles for both methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. Petraglia, FW., Farber, SH., Gramer, R., et al.[2022]

Cervical transcutaneous spinal cord stimulation (tSCS) can effectively activate sensory fibers at lower stimulation intensities when the cathode electrode is positioned at the C7 or T1 vertebra, compared to C6, which may enhance rehabilitation outcomes for upper-limb motor recovery after spinal cord injury.

Using smaller electrode sizes not only lowers the activation threshold for sensory fibers but also optimizes the recruitment of these fibers before α-motor fibers, suggesting a strategic approach to improve hand muscle activation during tSCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. de Freitas, RM., Capogrosso, M., Nomura, T., et al.[2022]

In a study of 69 patients with implanted spinal cord stimulators (SCSs) who underwent 78 MRI scans, the overall adverse event rate for off-label MRI use was low at 9.72%, with no serious adverse events reported.

All reported clinical adverse events were minor and resolved, suggesting that the benefits of MRI for pain management in patients with older SCS models may outweigh the associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. Ragukonis, T.[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]

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 double-blinded study involving 2 male patients with incomplete spinal cord injury, anodal transcutaneous spinal direct current stimulation (tsDCS) improved all measured outcomes, including gait and balance, while cathodal tsDCS showed mixed results.

Both types of tsDCS were able to modulate corticospinal excitability, indicating that this non-invasive method could be a promising approach for enhancing rehabilitation in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal direct current stimulation with locomotor training in chronic spinal cord injury. Abualait, TS., Ibrahim, AI.[2021]

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]

Citations

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

Protocol for a Systematic Review and Meta-Analysis - PMC Transcutaneous spinal cord stimulation (tSCS) has emerged as a promising neuromodulation technique for enhancing motor recovery and walking ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06587841

Noninvasive Spinal Cord Stimulation for Early SCI The purpose of this clinical study is to investigate the safety and effectiveness of non-surgical transcutaneous spinal cord stimulation (TSCS) in helping with ...

3. 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 ...

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

Transcutaneous Electrical Spinal Cord Stimulation to ... To evaluate the impact of using transcutaneous electrical spinal cord stimulation (TSCSTSCS) on upper and lower extremity function in individuals with chronic ...

5. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01545-8

Transcutaneous spinal cord stimulation combined with robotic ... The outcomes of this study suggest that the combination of standard Lokomat training with tSCS for 20 sessions was effective for LEMS and gait recovery in ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38958629/

Non-invasive Transcutaneous Spinal Cord Stimulation ... This study analyzes the stimulation parameters implemented during two successful trials that used non-invasive transcutaneous spinal cord stimulation (tSCS)