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

Trial Summary

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 data supports the effectiveness of the treatment Spinal Stimulation for Spinal Cord Injury?

Research shows that spinal cord stimulation (SCS) is effective in relieving chronic pain, especially in conditions like low back pain and neuropathic pain from failed back surgery. Although these studies focus on pain management, they suggest that SCS can provide long-term benefits by activating specific nerve fibers in the spinal cord. ^{1 2 3 4 5}

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation (SCS) has been used for over 40 years and is generally considered safe, though rare complications like spinal cord injury can occur. Most common issues are related to equipment malfunction rather than serious health risks. ^{4 6 7 8 9}

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

Spinal stimulation (also known as spinal cord stimulation or dorsal column stimulation) is unique because it uses electrical impulses to activate specific fibers in the spinal cord, which can help modulate pain perception and improve function. Unlike conventional treatments that may rely on medication or surgery, this approach directly targets the spinal cord to potentially provide relief and improve quality of life for those with spinal cord injuries. ^{1 2 3 4 10}

What is the purpose of this trial?

This trial is testing a method where small electrical currents are applied through the skin to stimulate the spinal cord. It aims to help people with spinal cord injuries improve their ability to move. The electrical signals may enhance communication between the brain and muscles, leading to better motor function. This technique has been explored for various applications, including pain control and muscle stimulation, and is now being tested for improving motor function in spinal cord injury patients.

Eligibility Criteria

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

I have a history of seizures.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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 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]

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 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]

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]

References

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

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

2. United States 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. [2023]

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

Alternate Intraspinal Targets for Spinal Cord Stimulation: A Systematic Review. [2022]

4. United States 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. [2021]

5. Korea (South) 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. [2021]

6. 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]

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

A report of paraparesis following spinal cord stimulator trial, implantation and revision. [2011]

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

Spontaneous resolution of nausea induced by spinal cord stimulation for failed back surgery syndrome. [2022]

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

[Minimally invasive implantation technique of a system for spinal cord stimulation]. [2021]