Spinal Stimulation for Spinal Cord Injury

Overseen By Kristine Cowley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Seizures, Head injury, Pacemaker, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how spinal stimulation might aid people with spinal cord injuries. It compares real stimulation with a sham version to assess any benefits. The trial seeks participants with a spinal cord injury between the neck and lower back (C4 to L4) who can follow instructions. Participants will receive 15 minutes of either real or sham stimulation. This study aims to help researchers determine the best use of spinal stimulation for spinal cord injuries.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance spinal cord injury treatments.

Do I need to stop 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 or your doctor.

What prior data suggests that this protocol is safe for spinal cord injury patients?

Research has shown that spinal cord stimulation is generally safe for people. One study reported no nerve damage or injury in patients who used this treatment, supporting its safety. This method uses electrical pulses near the spine to help manage pain and may also improve movement. So far, no serious side effects have been commonly reported, suggesting that spinal stimulation is well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spinal stimulation for spinal cord injury because it offers a novel approach by using electrical currents to potentially restore movement and sensation. Unlike traditional treatments, which mainly focus on rehabilitation and managing symptoms, spinal stimulation directly targets the spinal cord to promote neural activity and recovery. This method could drastically improve the quality of life for patients by enhancing their physical capabilities beyond what current therapies achieve. This innovative technique holds the promise of tapping into the body's own healing processes more effectively.

What evidence suggests that spinal stimulation is effective for spinal cord injury?

Research has shown that spinal stimulation, a treatment under study in this trial, can help people with spinal cord injuries improve movement. A review found that methods like skin stimulation can restore some movement. Another study highlighted that spinal stimulation may reduce pain and improve quality of life for patients. Some patients even reported complete pain relief with this treatment. These findings suggest spinal stimulation could be a promising option for those with spinal cord injuries. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for up to 24 people living with spinal cord injury (SCI), specifically those with paraplegia. The study aims to include individuals who can safely undergo various spinal stimulation protocols.

Inclusion Criteria

Patients must have the ability to understand and follow directions

My spinal cord injury is between my neck and lower back.

Exclusion Criteria

Pregnancy

History of unexplained loss of consciousness

Living with an implanted cochlear stimulator, brain/neurostimulator, cardiac pacemaker, medication infusion device, or metal implants in their body

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive spinal cord stimulation interventions, including sham and experimental stimulation, for 15 minutes each

1-2 weeks

Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of motor response and perception of discomfort

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Stimulation

Trial Overview The study tests transcutaneous spinal electrical stimulation methods in SCI patients. It compares the effects of different stimulations: EPS, DCS, and sham versions where no actual stimulation is given.

How Is the Trial Designed?

Group I: Spinal cord stimulation Experimental Treatment 2 Interventions

Spinal cord stimulation will be administered to participants for 15 min.

Group II: Shamspinal cord stimulation Placebo Group 2 Interventions

Sham spinal cord stimulation will be administered to participants for 15 min.

Spinal Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Spinal Cord Stimulation for:

• Failed back surgery syndrome (FBSS)
• Chronic pain
• Complex regional pain syndrome
• Intractable angina
• Visceral abdominal and perineal pain
• Pain in the extremities from nerve damage

Approved in European Union as Spinal Cord Stimulation for:

• Peripheral ischemic pain
• Failed back surgery syndrome (FBSS)
• Chronic pain
• Complex regional pain syndrome

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Published Research Related to This Trial

Spinal cord stimulation (SCS) is generally considered a safe procedure, but this report highlights four cases of neurological complications, including paraparesis, following SCS implantation, indicating that while rare, such injuries can occur.

Among the four patients, one experienced complete paraplegia, two had incomplete paraparesis, and one fully recovered, suggesting that outcomes can vary significantly and further research is needed to understand the true incidence of neurological injuries related to SCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A report of paraparesis following spinal cord stimulator trial, implantation and revision. Smith, CC., Lin, JL., Shokat, M., et al.[2011]

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]

A systematic review of 13 studies on non-dorsal column intraspinal stimulation for chronic pain relief suggests that targeting specific neuronal areas, like the cervicomedullary junction and dorsal root ganglion, may provide better pain management than conventional spinal cord stimulation.

This approach could potentially reduce unwanted side effects, such as paraesthesia in non-painful areas, indicating a promising direction for future pain treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternate Intraspinal Targets for Spinal Cord Stimulation: A Systematic Review. Chang Chien, GC., Mekhail, N.[2022]

In a study of 44 patients with chronic neuropathic pain from failed back surgery syndrome, 63.6% experienced successful trial stimulation with spinal cord stimulation (SCS).

The use of paddle electrodes was associated with higher success rates for trial stimulation, while severe sensory deficits in painful areas were linked to lower success rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with the success of trial spinal cord stimulation in patients with chronic pain from failed back surgery syndrome. Son, BC., Kim, DR., Lee, SW., et al.[2021]

In a study of 50 patients with lower back and/or leg pain, the novel closed-loop spinal cord stimulation (SCS) system demonstrated long-term effectiveness, with 76.9% of patients achieving at least 50% pain relief after 12 months.

The system maintained spinal cord activation within a therapeutic window for 84.9% of the time, and 68.8% of patients were able to reduce or eliminate their opioid use, highlighting both safety and efficacy in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained Long-Term Outcomes With Closed-Loop Spinal Cord Stimulation: 12-Month Results of the Prospective, Multicenter, Open-Label Avalon Study. Russo, M., Brooker, C., Cousins, MJ., et al.[2021]

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 54-year-old man experienced persistent nausea as an uncommon side effect after spinal cord stimulation (SCS) implantation, which resolved spontaneously within eight weeks, allowing him to continue using the device.

This case highlights the need for awareness and reporting of gastrointestinal side effects related to SCS, as understanding these rare occurrences can help maintain the therapeutic benefits of neurostimulation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneous resolution of nausea induced by spinal cord stimulation for failed back surgery syndrome. Vorenkamp, KE., Baker, NE.[2022]

Spinal cord stimulation (SCS) significantly outperformed conventional medical management (CMM) in reducing chronic low back pain, with 72.6% of SCS patients reporting a 50% reduction in pain compared to only 7.1% in the CMM group after six months.

Patients receiving SCS also showed substantial improvements in disability and overall function, with 91% reporting improvement compared to just 16% in the CMM group, alongside a notable reduction in opioid use and other pain management therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Refractory Low Back Pain Using Passive Recharge Burst in Patients Without Options for Corrective Surgery: Findings and Results From the DISTINCT Study, a Prospective Randomized Multicenter Controlled Trial. Deer, T., Gilligan, C., Falowski, S., et al.[2023]

In a study of 19 patients with failed back surgery syndrome, high frequency spinal cord stimulation (HF-SCS) significantly reduced pain levels, with visual analogue scale scores dropping from 71 mm for leg pain and 69 mm for back pain preoperatively to 18 mm and 24 mm, respectively, after 6 months.

The Oswestry Disability Index (ODI) improved from a mean of 63% preoperatively to 24% after 6 months, indicating a substantial enhancement in the patients' quality of life following HF-SCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Minimally invasive implantation technique of a system for spinal cord stimulation]. Kasapovic, A., Rommelspacher, Y., Walter, S., et al.[2021]

Intermittent spinal cord stimulation (SCS) has shown long-term beneficial effects primarily for neurogenic pain, particularly in conditions like radicular low-back pain after failed surgery and phantom pain, based on a study of 335 patients treated between 1972 and 1989.

Careful patient selection and improved technical methods have significantly enhanced the success rates of SCS, while it is less effective for pain related to progressive malignant diseases or complete nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Spinal neurostimulation for the treatment of chronic pain: changes in indications and patient selection after 19 years' experience.]. Winkelmüller, W.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6391880/

Spinal Cord Stimulation: Clinical Efficacy and Potential ... One of the first reports of dorsal column stimulation for the treatment of pain noted no changes in touch and vibration sensation, but an increase in pain ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12321793/

The effectiveness of spinal cord stimulation combined with ... This review aims to synthesize current evidence regarding pain relief, functional improvement, and quality of life outcomes associated with this ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923005755

Review article Spinal Cord Stimulation: An Update ... spinal cord stimulation systems. Of the 10 patients for whom detailed long–term efficacy data were available, 3 reported full relief from their pain and 7 ...

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/NCT06867809

NCT06867809 | Spine and Brain Stimulation for Movement ... Stimulation of the spinal cord and brain represents a new experimental therapy that may have potential to restore movement after spinal cord injury.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK553154/

Spinal Cord Stimulation - StatPearls - NCBI Bookshelf - NIH This technique uses pulsed electrical energy near the spinal cord to manage pain. This activity reviews the indications, contraindications, equipment, ...

7. aetna.com aetna.com/cpb/medical/data/100_199/0194.html

Spinal Cord Stimulation - Medical Clinical Policy Bulletins In a systematic review, these investigators examined safety and outcome data on DBS and SCS for patients with orthostatic tremor. ... Spinal electrical ...