Spinal Cord Stimulation for Spinal Cord Injury

Recruiting at 1 trial location

Overseen By Fiona E Fox, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: James J. Peters Veterans Affairs Medical Center

Disqualifiers: Seizures, Diabetes, Heart disease, others

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

Compensation: Varies

Number of Visits: 4

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how transcutaneous spinal cord stimulation (TSCS) can help individuals with long-term spinal cord injuries enhance their exercise ability and better manage body temperature. Participants will undergo both real and sham stimulation while using an arm bicycle or being in a cold room to determine the treatment's effectiveness. The trial seeks individuals who have had a spinal cord injury between the neck and upper back for over a year and have participated in a previous related study. The study aims to gather information rather than provide long-term benefits to participants. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could shape 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 it requires that your prescription medications have not changed for at least 30 days before participating.

What prior data suggests that transcutaneous spinal cord stimulation is safe for spinal cord injury patients?

Research has shown that transcutaneous spinal cord stimulation (TSCS) is generally safe for individuals with long-term spinal cord injuries. One study found that TSCS combined with rehabilitation was safe for those with neck-level spinal cord injuries, with no major safety issues reported, indicating good tolerance. Another study confirmed that TSCS is safe for the heart, suggesting it does not pose heart health risks. These findings suggest that participants in the trial should not expect serious side effects from TSCS treatment. However, as with any treatment, individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcutaneous spinal cord stimulation (TSCS) for spinal cord injury because it offers a non-invasive way to potentially restore some function by directly stimulating the spinal cord through the skin. Traditional treatments for spinal cord injuries often involve medications, surgery, and physical rehabilitation, which can be invasive and have varying degrees of success. TSCS is unique because it can be tailored specifically to each individual, using different pulse widths and stimulation locations, which might lead to better outcomes. By offering a more personalized approach, TSCS has the potential to improve quality of life for individuals with spinal cord injuries in ways that current treatments may not.

What evidence suggests that transcutaneous spinal cord stimulation is effective for spinal cord injury?

Research has shown that transcutaneous spinal cord stimulation (TSCS), a treatment participants in this trial may receive, can help individuals with spinal cord injuries enhance their movement and walking abilities. Some studies found that TSCS improves control over body movements, balance, and even assists with standing and walking. Additionally, TSCS has proven safe and effective when combined with walking-based therapies to enhance mobility. These improvements suggest that TSCS may also increase exercise endurance and help manage body temperature for those with long-term spinal cord injuries. ^{2 5 6 7 8}

Who Is on the Research Team?

Jill M Wecht, EdD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic spinal cord injury (SCI) between C3-T6, who have been injured for more than a year and haven't changed their meds in the last month. They should have previously participated in a related SCI study and not be pregnant or suffering from other neurological conditions, heart diseases, severe head trauma, psychological disorders, recent substance abuse, seizures, diabetes or untreated thyroid disease.

Inclusion Criteria

You have taken part in a previous study called 'Targeted Transcutaneous Spinal Cord Stimulation to Restore Autonomic Cardiovascular Health in Individuals with Spinal Cord Injury'.

You have been injured for more than 1 year.

My prescription medications have been the same for the last 30 days.

Exclusion Criteria

I rely on a ventilator for breathing or have an open tracheostomy.

I have had a serious head injury or have been diagnosed with cognitive impairment.

You currently have or have had a mental health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Phase

Participants receive active and sham TSCS during submaximal arm cycle ergometry to assess exercise endurance and heart rate recovery.

2 visits, 3-4 hours each

2 visits (in-person)

Cold Room Phase

Participants receive active and sham TSCS in a cool environment to assess body temperature regulation and thermal comfort.

2 visits, 3-4 hours each

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham Transcutaneous Spinal Cord Stimulation
• Transcutaneous Spinal Cord Stimulation (TSCS)

Trial Overview The study tests if transcutaneous spinal cord stimulation (TSCS) can help people with cervical SCI endure moderate exercise longer and regulate body temperature better compared to sham stimulation. Participants will try both real and fake stimulations while exercising or being exposed to cold temperatures.

How Is the Trial Designed?

Group I: Transcutaneous Spinal Cord Stimulation Experimental Treatment 1 Intervention

The transcutaneous spinal cord stimulation used in this experiment is specific to each participant as determined in a previous study. Possible parameters include biphasic or monophasic, Russian or Nonrussian, a variety of pulse widths, and location of stimulation (T7-8, T9-10,- T11-12, L1-2). The amplitude of the stimulation also depends on the results of the mapping study. This stimulation will be delivered 30 minutes at a time.

Group II: Sham Transcutaneous Spinal Cord Stimulation Placebo Group 1 Intervention

The sham stimulation will follow the above parameters but will only be delivered for a minute rather than the full 30 minutes.

Who Is Running the Clinical Trial?

James J. Peters Veterans Affairs Medical Center

Lead Sponsor

Trials

59

Recruited

2,900+

Published Research Related to This Trial

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 of 68 patients who had spinal cord stimulation paddle electrodes removed, the most common reason for removal was loss of coverage or effect (75%), indicating that while SCS is effective, it may not always provide lasting relief.

Postoperative complications occurred in 11.75% of patients, with two major complications requiring reoperation, highlighting that while SCS removal is generally safe, it does carry some risks that patients should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. Maldonado-Naranjo, AL., Frizon, LA., Sabharwal, NC., 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]

Spinal cord stimulation (SCS) is generally a safe and effective treatment option, with complications being uncommon according to a comprehensive literature review.

The review emphasizes the importance of proper patient selection and adherence to evidence-based guidelines to minimize the risk of complications during SCS implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticipating and preventing complications in spinal cord stimulator implantation. Falowski, SM., Tan, H., Parks, J., et al.[2023]

Transcutaneous Spinal Cord Stimulation (TSCS) can enhance the excitability of spinal neural circuits, which may improve voluntary performance in patients with incomplete spinal cord injuries (iSCI).

Combining TSCS with therapeutic interventions has the potential to accelerate recovery outcomes, although there is currently a gap in applying this knowledge to clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility and Feasibility of Transcutaneous Spinal Cord Stimulation for Patients With Incomplete SCI in Therapeutic Settings: A Review of Topic. Martin, R.[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]

A new animal model for transcutaneous spinal cord stimulation (tSCS) was developed, which accurately mimics human responses and allows for stable, repeated treatments after spinal cord injury (SCI) with minimal restraint.

The study demonstrated that tSCS can effectively modulate motor output in rats after complete spinal cord transection, suggesting its potential for promoting neuroplasticity and functional recovery in SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting Human-Based Transcutaneous Spinal Cord Stimulation to Develop a Clinically Relevant Animal Model. Malloy, DC., Knikou, M., Côté, MP.[2023]

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 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]

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

Safety and Effectiveness of Multisite Transcutaneous ... This study showed that tSCS combined with ABT is safe, feasible, and effective in adults with chronic SCI ranging from the cervical to thoracic level when ...

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

Transcutaneous Electrical Spinal Cord Stimulation to ... Enhanced trunk control and stability (9), improved lower extremity (LE) function, locomotor output, and standing (6, 8, 13) as well as reduced ...

4. nature.com nature.com/articles/s41394-020-00359-1

Feasibility and utility of transcutaneous spinal cord ... These data indicate that TSCS is both clinically feasible and may be a useful adjunct to walking-based therapy for individuals with motor iSCI.

5. e-neurospine.org e-neurospine.org/journal/view.php?doi=10.14245/ns.2244652.326

A Review of Functional Restoration From Spinal Cord ... This review aims to assess the efficacy of spinal cord stimulation, both epidural (eSCS) and transcutaneous (tSCS), on the return of function in individuals ...

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. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT07090473

UCSF Spinal Cord Injury Trial → Transcutaneous Electrical ... The goal of this study is to test whether electrical stimulation from the skin surface starting 3 days after spinal cord injury (SCI) is ...

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

Cardiovascular safety of transcutaneous spinal cord ... This study supports the safety profile of cervical tSCS paired with rehabilitation in individuals with cervical spinal cord injury.