50 Participants Needed

Epidural Stimulation for Spinal Cord Injury

(LTO Trial)

SC
Overseen ByStudy Coordinator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic 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, but you cannot participate if you need opioid pain medications or have used Botox in the last six months.

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

Research shows that epidural spinal cord stimulation can improve physical function after spinal cord injury and has been effective in managing chronic pain conditions, such as reflex sympathetic dystrophy and pain from failed back surgery. It has also been used successfully for neuropathic pain and vascular-linked pain, indicating its potential for broader applications.12345

Is epidural stimulation generally safe for humans?

Epidural stimulation, also known as spinal cord stimulation, is generally considered safe for treating chronic pain conditions, with rare complications such as spinal cord injury. Most common issues are equipment-related, and serious neurological injuries are very rare.678910

How does epidural spinal cord stimulation differ from other treatments for spinal cord injury?

Epidural spinal cord stimulation is unique because it involves placing electrodes on the spinal cord to send electrical signals, which can help improve movement and reduce pain in people with spinal cord injuries. Unlike other treatments, it directly targets the spinal cord to facilitate posture and locomotion, and it has shown promise in helping patients regain some ability to stand or step.45111213

Research Team

Dr. David Darrow, MD - Minneapolis, MN ...

David Darrow, MD MPH

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for adults over 22 with stable spinal cord injuries, who are not ventilator-dependent and have an existing, working FDA-approved spinal cord stimulator. They should be medically stable and at least a year out from their initial injury. Those with certain levels of impairment (AISA 'A' or 'B'), no recent Botox treatments, and not on opioid pain meds that would limit rehab participation can join.

Inclusion Criteria

Medically stable in the judgment of the Principal investigator
Able to undergo the informed consent process
Has an existing and functional implanted spinal cord stimulator system that is FDA approved and can be corroborated by hospital documentation
See 7 more

Exclusion Criteria

I need opioids for pain or have pain that might stop me from fully joining in the rehab program.
I have not had Botox injections in the last 6 months.
Clinically significant mental illness in the judgment of the principal investigator
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chronic spinal cord stimulation to restore volitional movement

10 years
2 visits per year (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Epidural Spinal Cord Stimulation
Trial OverviewThe study tests the long-term effects of chronic epidural spinal cord stimulation in restoring voluntary movement in patients with chronic spinal cord injuries. It aims to understand how this treatment helps over time.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Volitional EMG powerExperimental Treatment1 Intervention
Assessing the change in volitional EMG power during the Brain Motor Control Assement (BMCA) between nonstimulation baseline and stimulation.

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

🇪🇺
Approved in European Union as Spinal Cord Stimulation for:
  • Failed back surgery syndrome
  • Complex regional pain syndrome
  • Chronic neuropathic pain
  • Ischemic pain
🇺🇸
Approved in United States as Spinal Cord Stimulation for:
  • Failed back surgery syndrome
  • Complex regional pain syndrome
  • Chronic neuropathic pain
  • Ischemic pain
  • Diabetic neuropathy
🇨🇦
Approved in Canada as Spinal Cord Stimulation for:
  • Failed back surgery syndrome
  • Complex regional pain syndrome
  • Chronic neuropathic pain
  • Ischemic pain

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Findings from Research

Spinal cord epidural stimulation (SCES) not only aids in facilitating walking but also improves cardiovascular autonomic regulation and reduces spasticity in a 27-year-old male with a complete spinal cord injury, as shown in assessments conducted 15 weeks apart.
The study demonstrated that SCES can stabilize blood pressure during postural changes and significantly reduce muscle spasticity, suggesting that a single SCES configuration can provide multiple functional benefits, which may enhance its clinical application.
Effects of percutaneously-implanted epidural stimulation on cardiovascular autonomic function and spasticity after complete spinal cord injury: A case report.Gorgey, AS., Goldsmith, J., Alazzam, A., et al.[2023]
Epidural spinal cord stimulation (SCS) was tested on 18 patients with intractable pain from reflex sympathetic dystrophy (RSD), showing varying degrees of pain relief: 6 experienced good relief, 5 moderate, and 1 minimal, while 3 had no relief.
Despite some technical issues with the SCS systems, none of the patients experienced worsening neurological conditions, indicating that SCS may be a safe option for managing refractory RSD pain, though further research is needed to confirm its overall effectiveness.
Epidural spinal cord stimulation in the management of reflex sympathetic dystrophy.Barolat, G., Schwartzman, R., Woo, R.[2018]
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.
Alternate Intraspinal Targets for Spinal Cord Stimulation: A Systematic Review.Chang Chien, GC., Mekhail, N.[2022]

References

Effects of percutaneously-implanted epidural stimulation on cardiovascular autonomic function and spasticity after complete spinal cord injury: A case report. [2023]
Epidural spinal cord stimulation in the management of reflex sympathetic dystrophy. [2018]
Alternate Intraspinal Targets for Spinal Cord Stimulation: A Systematic Review. [2022]
Treatment of chronic pain by epidural spinal cord stimulation: a 10-year experience. [2011]
[Epidural spinal cord stimulation for therapy of chronic pain. Summary of the S3 guidelines]. [2021]
Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]
A report of paraparesis following spinal cord stimulator trial, implantation and revision. [2011]
Techniques for Safe Removal of Spinal Cord Stimulation Paddle Leads. [2022]
Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. [2022]
Experience with spinal cord stimulation (SCS) in the management of chronic pain in a traumatic transverse lesion syndrome. [2019]
Successful spinal cord stimulation for neuropathic below-level spinal cord injury pain following complete paraplegia: a case report. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Epidural stimulation: comparison of the spinal circuits that generate and control locomotion in rats, cats and humans. [2022]