Spinal Stimulation for Spinal Cord Injury

(SURe Trial)

Overseen By Bria Mellick, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Craig Hospital

Must be taking: Anti-spasticity

Must not be taking: Botox

Disqualifiers: Cardiac, Respiratory, Fractures, Pregnancy, 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: 6

Duration: 8 weeks

46 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to evaluate the safety, feasibility, and tolerability of non-invasive spinal stimulation used in the home and/or community in combination with a functional home exercise program for the upper extremities (arm/hand function) as well as their combined impacts on changes in upper extremity function. The expected duration of participation in this study is about 31-33 hours over a 13-25-week period. Enrollees in this study will be randomly assigned to one of two groups: 1) upper extremity functional task-specific training combined with non-invasive transcutaneous spinal stimulation, or 2) waitlist control, which involves the same intervention, but with a 12-week delayed start. Participants complete initial testing (one time if in group one and three times \[at weeks 0, 8, and 12\] if in group two), 24 1-hour training sessions (2x/week in home with caregiver/companion support and 1x/week with research team in person or via video conference for 8 weeks), a post-treatment evaluation, and a final evaluation (4 weeks after post-treatment).

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but if you are using prescribed anti-spasticity medications, you must be on a stable dose for at least four weeks before starting the study.

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 pain from failed back surgery. While the studies focus on pain relief, they suggest that SCS can be beneficial for managing certain types of pain, which may indirectly support its use in spinal cord injury treatment. ^{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 while it is generally considered safe, there are some risks. Rare complications include spinal cord injury and equipment failure, but these are uncommon. Most side effects are related to technical issues rather than direct harm to the spinal cord. ^{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 target specific areas of the spinal cord, aiming to modulate pain perception and improve function. Unlike conventional treatments that may rely on medication or surgery, this approach directly interacts with the nervous system to provide relief and potentially enhance recovery. ^{1 2 3 4 10}

Eligibility Criteria

This trial is for individuals with spinal cord injuries or a broken neck who are looking to improve their arm and hand functions. Participants should be able to commit to a 13-25 week program involving home exercises with caregiver support.

Inclusion Criteria

I can move my wrists, shoulders, and elbows normally.

My spinal cord injury is partially severe but not complete.

I have someone to help me with attending sessions and training at home.

Exclusion Criteria

Pregnant, planning to become pregnant, or currently breastfeeding

Concurrently are participating in another drug or device trial that may interfere with this study

Have an implanted pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intrathecal pump

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Testing

Initial baseline evaluation for both groups, with additional assessments at weeks 0, 8, and 12 for the waitlist control group

1 week

1 visit (in-person)

Treatment

Participants receive 24 training sessions of upper extremity functional task-specific training combined with non-invasive transcutaneous spinal stimulation over 8 weeks

8 weeks

2 visits (in-home), 1 visit (virtual) per week

Post-treatment Evaluation

Post-treatment evaluation conducted after the 8-week training period

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a final evaluation 4 weeks after post-treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Spinal Stimulation

Trial Overview The study tests if non-invasive spinal stimulation combined with functional home exercise can enhance upper extremity function. Half the participants start immediately, while the other half wait 12 weeks before beginning the same treatment.

Participant Groups

Group I: Immediate Intervention Active Control 1 Intervention

For the immediate intervention group, each participant will complete the following: * Initial baseline evaluation * 24 training sessions (3x/week for eight weeks) of UE Functional Task Practice (FTP)+TSS (two training sessions/week will be completed in the home with caregiver/companion support; the third weekly session will be conducted via videoconference with a research therapist) * Post-treatment evaluation (after eight weeks of training) and follow-up evaluation (four weeks after post-treatment evaluation). * Post-treatment and follow-up assessments will be conducted over two days: assessments completed without TSS on day one and with TSS on day two.

Group II: Waitlist Control Active Control 1 Intervention

The waitlist control group will participate in a protocol similar to the immediate intervention group, except: * 12-week waiting period before starting the active intervention. * Assessments will be completed at 0, 8, and 12 weeks before starting the active intervention to control for spontaneous recovery. * Post-treatment evaluation (after eight weeks of training) * Follow-up assessment (four weeks after the post-treatment evaluation).

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?

Craig Hospital

Lead Sponsor

Trials

45

Recruited

8,400+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

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]