Spinal Cord Stimulation for Spinal Cord Injury

Recruiting at 1 trial location

Overseen By Laura McCracken

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Intrathecal baclofen, Oral baclofen

Disqualifiers: Ventilator dependence, Cardiovascular disease, Seizures, Depression, others

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

Compensation: Varies

Number of Visits: 35

Duration: 8 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a pilot clinical trial to explore the efficacy of transcutaneous spinal cord stimulation (TCSCS) (proof-of-concept) in mitigating crucial autonomic dysfunctions that impact the health-related quality of life of individuals with spinal cord injury (SCI).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking oral baclofen over 60mg or have an intrathecal baclofen pump, you may not be eligible to participate.

What data supports the effectiveness of the treatment TESCoN device - Lumbosacral stimulation, TESCoN device - Thoracic stimulation for spinal cord injury?

Research shows that combining different types of spinal cord stimulation, like cervical and lumbar, can improve voluntary control of movement in people with chronic spinal cord injuries. Additionally, transcutaneous spinal cord stimulation has been found to enhance muscle activity and coordination, suggesting it can help improve motor function in those with spinal cord injuries. ^{1 2 3 4 5}

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation (SCS) is generally considered safe, with few reported complications, even in challenging environments like military settings. However, rare complications such as spinal cord compression and overstimulation leading to injury have been documented, indicating the need for careful monitoring and patient education. ^{6 7 8 9 10}

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

The TESCoN device treatment for spinal cord injury is unique because it involves lumbosacral and thoracic stimulation, which may offer a novel approach compared to traditional spinal cord stimulation methods. Unlike standard treatments that often require multiple cables, this device potentially simplifies the process by using fewer cables while still providing effective stimulation. ^{11 12 13 14 15}

Research Team

Andrei Krassioukov, MD, PhD

Principal Investigator

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

Eligibility Criteria

This trial is for adults aged 18-60 in British Columbia with chronic, non-progressive spinal cord injury at or above T6 and complete motor paralysis. Participants must be over a year post-injury, not have severe unrelated health issues, and use contraception if of childbearing potential.

Inclusion Criteria

I am using or willing to use contraception or abstain from sex during and for 28 days after the trial.

I can understand and complete English questionnaires or have access to a suitable interpreter.

I have problems with urination, bowel movements, or sexual function.

Exclusion Criteria

I don't have any severe health issues or take medications that would interfere with the study.

Intrathecal baclofen pump

Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo spatiotemporal mapping and baseline functional assessments

4 weeks

5 visits (in-person)

Treatment

Participants receive 8 weeks of transcutaneous spinal cord stimulation (TCSCS)

8 weeks

24 visits (in-person, 3 times/week)

Post-Treatment Assessment

Participants undergo functional assessments to evaluate the effects of TCSCS

4 weeks

5 visits (in-person)

Follow-up

Participants are monitored for persistent effects of TCSCS after cessation of therapy

8 weeks

Assessments repeated

Treatment Details

Interventions

• TESCoN device - Lumbosacral stimulation
• TESCoN device - Thoracic stimulation

Trial Overview The study tests the effectiveness of a noninvasive device called TESCoN for thoracic and lumbosacral stimulation to improve autonomic functions impaired by spinal cord injuries. It's a pilot trial to see how well it works to enhance life quality.

Participant Groups

Group I: Group 2- Lumbosacral stimulation Experimental Treatment 1 Intervention

Participants will receive 8 weeks TCSCS at the lumbosacral spinal cord levels.

Group II: Group 1 - Thoracic stimulation Experimental Treatment 1 Intervention

Participants will receive 8 weeks TCSCS at the mid/low thoracic spinal cord levels.

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+

Findings from Research

Transspinal stimulation (TSS) is a promising non-invasive neuromodulation technique that can activate spinal cord circuits to improve motor function in individuals with spinal cord injury, as evidenced by a review of 34 studies.

The review highlighted that multisite electrode placements generally resulted in better motor responses compared to single-site placements, suggesting that optimizing stimulation parameters is crucial for enhancing treatment outcomes, although further controlled studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of Transspinal Stimulation Applications for Motor Recovery after Spinal Cord Injury: Scoping Review. Rehman, MU., Sneed, D., Sutor, TW., et al.[2023]

Spinal cord stimulation (SCS) is effective in improving pain relief, sleep quality, and functional activities in patients with chronic pain, as shown by a survey of 30 patients who reported positive outcomes after receiving different SCS devices.

While there were no significant differences in pain relief and sleep improvement among the three SCS device manufacturers (Medtronic, Advanced Bionics, and ANS), the Advanced Bionics group showed less functional improvement compared to the other two groups, suggesting that device technology may influence certain outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of spinal cord stimulation, overall, and the effect of differing spinal cord stimulation technologies on pain, reduction in pain medication, sleep, and function. Haddadan, K., Krames, ES.[2022]

Spinal cord stimulators (SCS) and peripheral nerve stimulators (PNS) are effective treatments for chronic pain, enabling many military service members to return to work and daily activities.

Despite potential environmental and occupational hazards faced by military personnel, the risk of complications from SCS and PNS devices remains low, indicating their safety in these challenging conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Military concerns for chronic pain stimulator devices. Hughey, S., Field, R., Campbell, D., et al.[2023]

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 examining spinal cord stimulation parameters, pulse width (Pw) significantly influenced stimulation thresholds, but did not affect the coverage or quality of paresthesia experienced by patients.

Frequency (F) adjustments were found to be crucial for enhancing the coverage of painful areas and improving the quality of paresthesia perception, suggesting that frequency management is key for effective pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electric parameters optimization in spinal cord stimulation. Study in conventional nonrechargeable systems. Abejón, D., Cameron, T., Feler, C., et al.[2022]

The Evoke® spinal cord stimulation (SCS) device uses real-time feedback from the spinal cord to adjust stimulation levels, which is a unique feature not found in other commercially available SCS devices.

A systematic review of data over 24 months shows that the Evoke system is both safe and effective for treating chronic intractable pain, providing strong evidence for its clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device profile of the Evoke physiologic closed-loop spinal cord stimulation system for the treatment of chronic intractable pain: overview of its safety and efficacy. Poree, L., Foster, A., Staats, PS.[2023]

The study successfully demonstrated the feasibility of implanting surgical paddle electrodes in the cervical and thoracic spine using a minimally invasive endoscopic technique, with all procedures completed without complications in four cadavers.

No dura rupture occurred during the surgeries, and the implantation was efficient, with most operations taking less than one hour, indicating a promising alternative to traditional open surgery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantation of Surgical Paddle Electrodes Using Percutaneous Biportal-Endoscopic Technique for Spinal Cord Stimulation: An Anatomical Feasibility Study in Human Cadavers. Li, C., Jiang, Y., Liu, T., et al.[2023]

References

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

Augmentation of Voluntary Locomotor Activity by Transcutaneous Spinal Cord Stimulation in Motor-Incomplete Spinal Cord-Injured Individuals. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Estimating the user population of a simple electrical stimulation system for standing. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Combined cervical transcutaneous with lumbosacral epidural stimulation improves voluntary control of stepping movements in spinal cord injured individuals. [2023]

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

Optimization of Transspinal Stimulation Applications for Motor Recovery after Spinal Cord Injury: Scoping Review. [2023]

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

Preferential activation of spinal sensorimotor networks via lateralized transcutaneous spinal stimulation in neurologically intact humans. [2020]

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

The effect of spinal cord stimulation, overall, and the effect of differing spinal cord stimulation technologies on pain, reduction in pain medication, sleep, and function. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Military concerns for chronic pain stimulator devices. [2023]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Spinal cord stimulator medullary compression-a very rare SCS complication and surgical treatment. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

[Compound acetabulum fracture caused by overstimulation with a PISCES system]. [2006]

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

Comparison of a novel fixation device with standard suturing methods for spinal cord stimulators. [2022]

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

Electric parameters optimization in spinal cord stimulation. Study in conventional nonrechargeable systems. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Device profile of the Evoke physiologic closed-loop spinal cord stimulation system for the treatment of chronic intractable pain: overview of its safety and efficacy. [2023]

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

Realization of an active book for multichannel intrathecal root stimulation in spinal cord injury--preliminary results. [2020]

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

Implantation of Surgical Paddle Electrodes Using Percutaneous Biportal-Endoscopic Technique for Spinal Cord Stimulation: An Anatomical Feasibility Study in Human Cadavers. [2023]