Spinal Cord Stimulation for Spinal Cord Injury

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device that stimulates parts of the spinal cord to help individuals with spinal cord injuries manage bladder, bowel, or sexual function issues. Participants will receive stimulation at either the mid/low thoracic or lumbosacral spinal cord levels over eight weeks using the TESCoN device. The trial seeks participants in British Columbia who have had a spinal cord injury for over a year, affecting their motor control and daily life. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for those with 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. However, if you are taking oral baclofen over 60mg or have an intrathecal baclofen pump, you may not be eligible to participate.

What prior data suggests that the TESCoN device is safe for spinal cord stimulation?

Studies have shown that transcutaneous spinal cord stimulation (TCSCS) is generally well-tolerated. Research indicates that using the TESCoN device for upper back stimulation did not cause significant safety issues. Specifically, one study found it improved bladder function and sensation without serious side effects.

For lower back stimulation, reports also suggest safety. A study showed improvements in bladder and bowel function, again with no major adverse events. This suggests the treatment is safe for people, although individual experiences may vary. Always consult a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TESCoN device treatments for spinal cord injury because they offer a unique approach through targeted spinal cord stimulation. Unlike standard treatments that often focus on medication and physical therapy, TESCoN devices directly stimulate the spinal cord at specific regions—either the thoracic or lumbosacral levels. This precise stimulation method could enhance nerve function and promote recovery in ways that current options cannot. By directly engaging with the spinal cord's electrical activity, there's potential for improved mobility and sensation, offering hope for better outcomes in spinal cord injury rehabilitation.

What evidence suggests that the TESCoN device is effective for spinal cord injury?

Research has shown that the TESCoN device for transcutaneous spinal cord stimulation (TCSCS) can improve certain functions after a spinal cord injury. In this trial, participants in Group 1 will receive thoracic stimulation. Studies indicate this can reduce bladder overactivity, leading to better bladder control and sensation, potentially managing bladder issues for those with spinal cord injuries. Participants in Group 2 will receive lumbosacral stimulation, which has shown improvements in both bladder and bowel functions, significantly enhancing quality of life. Both types of stimulation are noninvasive, requiring no surgery, making them a promising option for individuals with spinal cord injuries. ^{1 2 4 5 6}

Who Is on the Research Team?

Andrei Krassioukov, MD, PhD

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05369520

Noninvasive Spinal Cord Stimulation for Recovery of ... This study is a pilot clinical trial to explore the efficacy of transcutaneous spinal cord stimulation (TCSCS) (proof-of-concept) in mitigating crucial ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7017715/

Transcutaneous Electrical Spinal Cord Neuromodulator ... We found that TESCoN led to decreased detrusor overactivity, improved continence, and enhanced LUT sensation across the different pathologies underlying LUT ...

3. withpower.com withpower.com/trial/phase-wounds-and-injuries-9-2022-a9f93

Spinal Cord Stimulation for Spinal Cord Injury Trial Overview The study tests the effectiveness of a noninvasive device called TESCoN for thoracic and lumbosacral stimulation to improve autonomic functions ...

4. medrxiv.org medrxiv.org/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05369520&atom=%2Fmedrxiv%2Fearly%2F2025%2F09%2F12%2F2025.09.11.25335523.atom

NCT05369520 | Noninvasive Spinal Cord Stimulation for ... This study is a pilot clinical trial to explore the efficacy of transcutaneous spinal cord stimulation (TCSCS) (proof-of-concept) in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12412244/

Multi-system benefits of non-invasive spinal cord stimulation ... Following 30 sessions of lumbosacral tSCS, the individual presented with improved urinary bladder compliance as well as anorectal function in ...

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

Non-invasive spinal cord electrical stimulation for arm and ... Secondary endpoint analysis revealed significant improvements in fingertip pinch force, hand prehension and strength, upper extremity motor and ...