Noninvasive Stimulation for Spinal Cord Injury

Overseen By Andrea Maharaj, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: OnabotulinumtoxinA, others

Disqualifiers: Depression, PTSD, Bladder surgery, others

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

Compensation: Varies

Number of Visits: 58

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a non-invasive method called transcutaneous spinal cord stimulation (TSCS) can help people regain certain body functions after a spinal cord injury. It aims to improve bladder, bowel, sexual, and heart functions, reduce muscle tightness, and ultimately enhance quality of life. Participants will be divided into two groups: one will receive real stimulation, and the other will receive a placebo before both eventually receive the real treatment. The trial is suitable for individuals who have had a spinal cord injury for 3 to 6 months and experience bladder function issues.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could significantly enhance recovery options for spinal cord injury patients.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but you must notify the Principal Investigator if you start any new medications for bowel and lower urinary tract management during the study.

What prior data suggests that this non-invasive transcutaneous spinal cord stimulation is safe for individuals with spinal cord injury?

Research has shown that transcutaneous spinal cord stimulation (TSCS) is generally safe for people with spinal cord injuries. Studies indicate that combining TSCS with activity-based therapy can be effective without causing major side effects. In previous studies, participants did not report serious problems, suggesting that the treatment is well-tolerated. Another study found that TSCS is safe to use at home or in a clinic to help improve strength and function. These findings support the safety of TSCS for people considering this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spinal cord neuromodulation for spinal cord injury because it offers a noninvasive approach that could sidestep the need for surgery. Unlike traditional treatments, which often involve medication or invasive procedures, this method uses transcutaneous spinal cord stimulation (TSCS) to target specific spinal segments from outside the body. By delivering electrical stimulation through the skin, it potentially enhances nerve function and recovery without the risks associated with surgery. This innovative approach could provide a safer, more accessible option for improving mobility and quality of life in individuals with spinal cord injuries.

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

Research has shown that transcutaneous spinal cord stimulation (TSCS) may aid recovery from spinal cord injuries. In this trial, participants in Group 1 will receive TSCS at or between cervical spinal segment 5 (C5) and thoracic spinal segment 10 (T10). Studies have found that combining TSCS with physical therapy can enhance movement and leg function. Specifically, one study showed that patients experienced better motor skills and improved walking ability after using TSCS with robotic training. Another report noted that repeated TSCS sessions aided overall recovery. These findings suggest that TSCS could also improve bladder, bowel, sexual, and heart functions, and reduce muscle stiffness (spasticity) for those with spinal cord injuries. ^{2 6 7 8 9}

Who Is on the Research Team?

Andrei Krassioukov, MD,PhD,FRCPC

Principal Investigator

The University of British Columbia, International Collaboration on Repair Discoveries (ICORD)

Are You a Good Fit for This Trial?

This trial is for adults with recent spinal cord injuries (3-6 months ago) who are experiencing issues with bladder, bowel, sexual function, or muscle spasms. It's taking place in Canada and Ukraine. Participants will join a study lasting about 33 weeks to see if non-invasive spine stimulation helps improve these functions.

Inclusion Criteria

My spinal injury level is between C5 and T10 and is classified as severe or moderate.

My spinal cord injury occurred between 3 to 6 months ago.

I have documented issues with bladder function.

Exclusion Criteria

I haven't had Botox injections in my bladder or sphincter muscles in the last 9 months.

I show symptoms of nerve damage in my muscles.

I have cognitive impairments or psychological issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Group 1 receives therapeutic TSCS and Group 2 receives sham stimulation for 8 weeks

8 weeks

24 visits (in-person)

Treatment Phase 2

Group 1 continues TSCS therapy and Group 2 switches to therapeutic TSCS for another 8 weeks

8 weeks

24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

10 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Cord Neuromodulation (SCONE) for Transcutaneous Spinal Cord Stimulation (TSCS)

Trial Overview The SCONE™ device for transcutaneous spinal cord stimulation (TSCS) is being tested. Participants are split into two groups: one gets real TSCS plus regular rehab for 16 weeks; the other starts with fake stimulation then switches to real TSCS after 8 weeks.

How Is the Trial Designed?

Group I: Group 1 Treatment Experimental Treatment 1 Intervention

TSCS at or between cervical spinal segment 5 (C5) and thoracic spinal segment 10 (T10) at Intervention Phases 1 and 2, 8 weeks each.

Group II: Group 2 Sham Placebo Group 1 Intervention

TSCS at or between C5 and T10 at Intervention Phase 2; 8 weeks.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Rivne Regional War Veterans Hospital, Spinal Cord Injury Rehabilitation Center

Collaborator

Trials

1

Recruited

60+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Published Research Related to This Trial

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]

Spinal cord stimulation effectively reduces neuropathic pain and improves quality of life, particularly in patients with failed back surgery syndrome when other treatments have not worked.

Newer stimulation techniques, such as burst and high-frequency stimulation, show promise for providing better pain relief compared to traditional methods, although complications can occur, they are generally not life-threatening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic non-cancer pain: a review of current evidence and practice. Wong, SS., Chan, CW., Cheung, CW.[2018]

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]

A patient experienced neurological complications, including tinnitus, vertigo, and facial twitches, after receiving a high-frequency spinal cord stimulator, which resolved upon deactivation of the device.

This case highlights the need for further research into the less common neurological side effects of spinal cord stimulation therapy, as current knowledge primarily focuses on surgical site infections and hardware issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Onset Tinnitus after High-Frequency Spinal Cord Stimulator Implantation. Golovlev, AV., Hillegass, MG.[2020]

Noninvasive electrical neuromodulation treatments, specifically trans-spinal direct current stimulation (tsDCS) and trans-spinal pulsed current stimulation (tsPCS), show promise in improving sensorimotor and autonomic functions in individuals with spinal cord injury, based on a review of about 150 studies.

These treatments are noninvasive and cost-effective, suggesting they could be integrated into standard rehabilitation practices for spinal cord injury, potentially enhancing the quality of life for affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trans-Spinal Electrical Stimulation Therapy for Functional Rehabilitation after Spinal Cord Injury: Review. Rahman, MA., Tharu, NS., Gustin, SM., et al.[2022]

A novel percutaneous technique for spinal cord stimulation (SCS) was developed to introduce small profile paddle leads using the Epiducer lead delivery system, enhancing the implantation process.

This method utilizes a blunt Tuohy needle and fluoroscopic guidance to ensure accurate placement of the electrode in the epidural space, potentially improving the safety and efficacy of SCS procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel percutaneous technique to implant plate-type electrodes. Logé, D., De Coster, O., Pollet, W., et al.[2012]

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]

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]

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 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]

Citations

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

Effectiveness of Transcutaneous Spinal Cord Stimulation for ... The primary outcome will be lower limb motor function assessed by validated measures such as the Lower Extremity Motor Score. Secondary outcomes ...

2. 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 ...

3. 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 ...

4. 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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06587841

Noninvasive Spinal Cord Stimulation for Early SCI The investigators are looking to determine the safety and efficacy of non-invasive transcutaneous spinal cord stimulation (TSCS) in promoting recovery of ...

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

Safety and Effectiveness of Multisite Transcutaneous ... These findings indicate that prolonged training with tSCS-ABT can be an effective neuromodulatory intervention for individuals with SCI.

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

Transcutaneous Electrical Spinal Cord Stimulation to ... Injury volume extracted from MRI predicts neurologic outcome in acute spinal cord injury: a prospective TRACK-SCI pilot study. J Clin ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06242873?cond=Spinal%20Cord%20Injury&viewType=Table&rank=6

Transcutaneous Spinal Cord Stimulation in Children With ... We hypothesize that concurrent TSCS and gait training will augment walking function in children with iSCI, as compared to gait training with sham stimulation.

9. neurology.org neurology.org/doi/10.1212/WNL.0000000000205724

Transcutaneous Spinal Cord Stimulation (ARC-EX Therapy ... Conclusions: Clinic and home-based ARCEX Therapy is safe and effectively improves upper extremity strength and function in people living with chronic, cervical ...