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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of non-invasive spinal stimulation (also known as Spinal Cord Stimulation or SCS) combined with a home exercise program to improve arm and hand function in people with spinal cord injuries. Participants will be randomly assigned to start the intervention immediately or after a 12-week wait. It is ideal for those who have experienced a traumatic spinal cord injury (SCI) at the neck level within the past year and have a caregiver to assist with sessions. The study involves approximately 31-33 hours over 13-25 weeks, including both home-based and in-person training. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance rehabilitation options for spinal cord injury patients.

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

Research has shown that spinal stimulation is generally safe for people. For instance, one study found no reports of nerve problems or injuries in patients using spinal cord stimulation, indicating it is well-tolerated. Another study examined transcutaneous spinal cord stimulation (tSCS) and found promising safety results when combined with exercise-based therapy, with no major issues reported. Additionally, a report highlighted the safety of a similar therapy called ARC EX Therapy, which improves hand and arm function in people with spinal cord injuries. Overall, current evidence supports the safety of spinal stimulation for humans. ^{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 unique approach compared to current treatments like physical therapy and medication management. Unlike traditional therapies that primarily focus on managing symptoms and rehabilitation, spinal stimulation directly targets the nervous system to potentially enhance recovery and improve function. This technique may allow individuals to regain more control over their movements by reactivating neural pathways, which can be a game-changer for those affected by spinal cord injuries. This innovative method holds the promise of not just managing but potentially reversing some effects of spinal cord injuries, offering new hope for recovery.

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

Research shows that spinal stimulation, particularly transcutaneous spinal cord stimulation (tSCS), may help people with spinal cord injuries regain some function. Studies have found that tSCS can enhance motor function, leading to better movement and control. Some research also suggests that spinal stimulation can relieve pain and increase sensation in certain conditions. While primarily known for pain management, its potential to improve arm and hand movement is gaining recognition. In this trial, participants in the immediate intervention group will receive spinal stimulation to evaluate its effectiveness in enhancing arm and hand function for those with spinal cord injuries. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

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

Spinal Cord Stimulation: Clinical Efficacy & Mechanisms 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. 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 ...

3. 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 ...

4. mdpi.com mdpi.com/2076-3425/14/12/1173

Spinal Cord Stimulation for Spinal Cord Injury-Related Pain SCS has been particularly effective in treating mixed neuropathic pain, complex regional pain syndrome (CRPS), failed back surgery syndrome (FBSS), and ...

5. janesthanalgcritcare.biomedcentral.com janesthanalgcritcare.biomedcentral.com/articles/10.1186/s44158-024-00219-6

addressing persistent doubts in spinal cord stimulation Over the past 50 years, spinal cord stimulation (SCS) has emerged as one of the most effective treatments for chronic pain.

6. 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.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ... Objective. Evaluate the preliminary safety and efficacy of multi-site transcutaneous spinal cord stimulation (tSCS) combined with activity-based therapy (ABT) ...

8. 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 ...

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

Non-invasive spinal cord electrical stimulation for arm and ... These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.