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

Trial Summary

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 data supports the effectiveness of the treatment Spinal Cord Neuromodulation (SCONE) for Transcutaneous Spinal Cord Stimulation (TSCS)?

Research shows that transcutaneous spinal cord stimulation (tSCS) can help improve muscle activation and voluntary movement in people with spinal cord injuries. Studies have found that tSCS can enhance motor function in both the upper and lower limbs, suggesting it may be a promising treatment for improving movement and strength. ^{1 2 3 4 5}

Is noninvasive spinal cord stimulation generally safe for humans?

Transcutaneous spinal cord stimulation (tSCS) is considered relatively safe, with low rates of serious complications reported in studies. While some complications like infections or device issues can occur, they are rarely life-threatening or permanently disabling. ^{2 6 7 8 9}

How is the SCONE treatment for spinal cord injury different from other treatments?

The SCONE treatment, which involves transcutaneous spinal cord stimulation (tSCS), is unique because it is a non-invasive method that uses electrodes to stimulate the spinal cord and promote motor recovery. Unlike traditional rehabilitation methods, tSCS can enhance voluntary movement and muscle strength without surgery, making it a promising option for improving function in individuals with spinal cord injury. ^{2 3 5 10 11}

What is the purpose of this trial?

The investigators are looking to determine the safety and efficacy of non-invasive transcutaneous spinal cord stimulation (TSCS) in promoting recovery of lower urinary tract (LUT), bowel, sexual, and cardiovascular function, as well as spasticity in individuals with subacute SCI (time since injury 3-6 months) and the impact on quality of life. The study will be conducted at two sites; site 1 in Canada and site 2 in the Ukraine. Up to 60 subjects will be enrolled; 10 adults at the ICORD, University of British Columbia (UBC), Vancouver, Canada site and 50 adults at the Rivne Regional War Veterans Hospital, Rivne, Ukraine. Eligible participants will be randomized (1:1 ratio) either to Group 1 (G1) or Group 2 (G2). G1 will receive therapeutic TSCS for 8 weeks (3 times per week; 1 hour per session) in conjunction with conventional rehabilitation (3-4 hours per day; 5 days per week). G2 will receive 8 weeks of sham stimulation in conjunction with conventional rehabilitation. After 8 weeks, G2 will cross over and receive therapeutic TSCS for 8 weeks, whereas G1 will continue to receive TSCS therapy for another 8 weeks, for a total of 16 weeks. Eligible participants enrolled into the study will attend fifty eight (58) visits for assessments, therapy, and follow-up. The expected duration of study participation for each participant will be 33 weeks.

Research Team

Andrei Krassioukov, MD,PhD,FRCPC

Principal Investigator

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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 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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

A novel percutaneous technique to implant plate-type electrodes. [2012]

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

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

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

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. [2021]

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

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

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

The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. [2022]

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

New Onset Tinnitus after High-Frequency Spinal Cord Stimulator Implantation. [2020]

9. China pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic non-cancer pain: a review of current evidence and practice. [2018]

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

Enhanced selectivity of transcutaneous spinal cord stimulation by multielectrode configuration. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Trans-Spinal Electrical Stimulation Therapy for Functional Rehabilitation after Spinal Cord Injury: Review. [2022]