Spinal Cord Stimulation for Healthy Adults

Overseen By Sara Prokup, PT, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Neurologic pathologies, Pregnancy, Cancer, others

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

Compensation: Varies

Number of Visits: 1

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different methods of electrical stimulation on the spine, specifically through Transcutaneous Spinal Cord Stimulation (tSCS), affect muscle activity and comfort levels in individuals without neurological issues. It tests various electrical waveforms and modulation frequencies, as well as different points on the spine, to determine the most effective approach for activating leg muscles. The trial seeks adults without neurological conditions or specific health issues such as seizures, cancer, or heart devices.

As an unphased trial, this study allows participants to contribute to pioneering research that could improve future spinal treatments.

Do I need to stop taking my current medications for the trial?

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

What prior data suggests that transcutaneous spinal cord stimulation is safe for healthy adults?

Research has shown that transcutaneous spinal cord stimulation (tSCS) is generally safe. In one study, researchers found no serious side effects when using tSCS on individuals with spinal cord injuries. Another study demonstrated that tSCS did not cause major issues with heart or blood flow in participants.

Most studies have focused on individuals with spinal cord injuries, but no evidence suggests that tSCS would be unsafe for healthy individuals. The treatment is non-invasive, meaning it doesn't involve surgery, which usually makes it easy to tolerate. Participants typically feel comfortable during the process, though some might experience mild discomfort.

Overall, research supports tSCS as a safe option, especially since previous studies have reported no serious adverse events. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring new ways to stimulate the spinal cord that could lead to innovative treatments for conditions affecting motor function. Unlike traditional methods, which often use fixed stimulation patterns, this trial is testing different waveform combinations and stimulation locations to see how they impact muscle response and comfort. By using Spinally Evoked Motor Potentials (sEMP) to assess the effects, the trial aims to fine-tune the delivery of electrical stimulation for better outcomes. This approach could pave the way for more personalized and effective therapies by pinpointing the optimal stimulation techniques for individuals.

What evidence suggests that transcutaneous spinal cord stimulation is effective for muscle activation and comfort in healthy adults?

Studies have shown that transcutaneous spinal cord stimulation (tSCS) can help people with spinal cord injuries move better and regain feeling. This non-surgical method uses electrical currents applied to the skin to stimulate muscles and nerves, improving their function. Research suggests that combining tSCS with other therapies can enhance recovery, especially after multiple sessions. Early findings indicate that tSCS is safe and effective for improving movement in people with spinal cord issues. In this trial, researchers will divide participants into different arms to study how tSCS affects muscle activation and comfort in healthy adults without neurological conditions. One arm will test various waveform combinations, while the other will explore different stimulation locations. ^{1 2 6 7 8}

Who Is on the Research Team?

Arun Jayarman, PT, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-75 who can consent to study procedures. It's not suitable for those with metal implants in the back, unstable health conditions like uncontrolled hypertension, pregnant or nursing individuals, people with a history of neurological disorders, skin allergies or open wounds, users of certain cardiac devices, or anyone with a recent history of cancer.

Inclusion Criteria

Able and willing to give written consent and comply with study procedures

Exclusion Criteria

I have a history of stroke or neurological conditions like MS, Alzheimer's, or Parkinson's.

I have skin allergies, irritations, or open wounds.

I have pain in my muscles or joints due to injury or infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive transcutaneous spinal cord stimulation with varying parameters to assess motor responses and comfort

5 weeks

1-10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Spinal Cord Stimulation

Trial Overview The study is examining how different ways of delivering transcutaneous spinal cord stimulation (tSCS) affect muscle activation and comfort in the legs. This includes looking at various waveforms, frequencies and where on the body the stimulation is applied.

How Is the Trial Designed?

Group I: Stimulation Location Experimental Treatment 2 Interventions

Spinally Evoked Motor Potentials (sEMP) will be obtained while stimulating the spinal cord at various stimulation locations with single pulses. sEMP are the electromyograph responses of the peripheral muscles to electrical stimulation of the spinal cord. Participants will also ambulate while receiving continuous stimulation to various stimulation locations to determine what stimulation intensity is comfortable for each location. The order we complete this testing will be randomized. All participants will perform testing in a different order.

Group II: Carrier frequency + Waveform Experimental Treatment 2 Interventions

Spinally Evoked Motor Potentials (sEMP) will be obtained while stimulating the spinal cord at a single site with single pulses. sEMP are the electromyograph responses of the peripheral muscles to electrical stimulation of the spinal cord. We will test various waveform combinations of biphasic and monophasic waveforms with modulation frequencies of 0-10 kHz. Participants will also ambulate while receiving continuous stimulation of the various waveform combinations to determine what stimulation intensity is comfortable for each combination. The order we complete this testing will be randomized. All participants will perform testing in a different order.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

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) 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]

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 (TSS) significantly affects brain activity, activating key areas related to movement control and planning, as shown by EEG analysis in five participants performing lower-limb tasks.

TSS resulted in notable changes in functional connectivity in the brain during stimulation, unlike functional electrical stimulation (FES), suggesting TSS may be more effective for enhancing cortical engagement in rehabilitation strategies for spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous spinal stimulation on spatiotemporal cortical activation patterns: a proof-of-concept EEG study. Steele, AG., Manson, GA., Horner, PJ., et al.[2022]

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]

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]

Transcutaneous spinal cord stimulation (TSCS) therapy significantly altered brain activity related to bladder function in stroke patients with lower urinary tract dysfunction (LUTD), making their brain activity patterns more similar to those of healthy individuals.

After 24 sessions of TSCS, patients showed clinically meaningful improvements in urinary function, as indicated by validated questionnaires and voiding diaries, highlighting TSCS as a promising treatment for LUTD following stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of the Effect of Transcutaneous Spinal Cord Stimulation on Micturition-Related Brain Activity and Lower Urinary Tract Symptoms After Stroke. Kreydin, EI., Abedi, A., Montero, VS., et al.[2023]

Transcutaneous spinal direct current stimulation (tsDCS) is a safe technique that can effectively modulate spinal cord excitability, as shown by changes in motor-evoked potentials (MEPs) in healthy subjects after stimulation.

The study found that cathodal tsDCS increased MEP amplitudes indicating enhanced inhibitory GABA(A)ergic drive, while anodal tsDCS had the opposite effect, suggesting tsDCS could be a promising rehabilitation strategy for patients with acute brain lesions or spinal diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Direct Current Stimulation Modulates Short Intracortical Inhibition. Bocci, T., Barloscio, D., Vergari, M., et al.[2022]

Noninvasive transcutaneous spinal cord stimulation (tSCS) has been shown to effectively induce muscle activation in individuals with spinal cord injury, based on a systematic review of 13 studies involving 55 participants.

While tSCS appears to enhance voluntary movement, muscle strength, and function, further research is needed to determine the optimal electrode placement and current intensity for maximum efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. Megía García, A., Serrano-Muñoz, D., Taylor, J., et al.[2021]

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/PMC12548825/

Protocol for a Systematic Review and Meta-Analysis - PMC This systematic review and meta-analysis will determine the effectiveness of tSCS, compared with sham stimulation, no intervention, or other ...

2. 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 ...

3. 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.

4. 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 ...

5. withpower.com withpower.com/trial/phase-healthy-adults-10-2023-8af74

Spinal Cord Stimulation for Healthy Adults Research shows that transcutaneous spinal cord stimulation (tSCS) can help improve motor function and sensorimotor recovery in people with spinal cord injuries ...

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

UCSF Spinal Cord Injury Trial → Transcutaneous Electrical ... To assess safety, we will quantify the impacts of tSCS on hemodynamics, spinal cord perfusion pressure (SCPP), and monitor for local skin site ...

7. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... No serious adverse events related to ARCEX Therapy were reported, and the primary effectiveness endpoint was met. Seventy-two percent of ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8601579/

Transcutaneous spinal cord stimulation and motor responses ... This review aimed to evaluate the methodology of studies using tSCS to generate motor activity in persons with spinal cord injury (SCI)