100 Participants Needed

Epidural Spinal Cord Stimulation for Spinal Cord Injury

(E-STAND Trial)

SC
David Darrow, MD MPH profile photo
Overseen ByDavid Darrow, MD MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will evaluate a method to optimize parameter settings in epidural spinal cord stimulation used to recover lower extremity volitional movement. The study will also characterize improvement in autonomic function (such as blood pressure control) and other functions related to spinal cord injury.

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 take antiplatelet or anticoagulation agents around the time of surgery, and you cannot have a current or anticipated need for opioid pain medications.

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation is generally considered safe, with rare reports of serious complications like spinal cord injury. The most common issue is equipment failure, and while some risks like infection or dural puncture (a tear in the outer membrane of the spinal cord) exist, they are not common.12345

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

Epidural spinal cord stimulation (SCS) is unique because it uses electrical impulses to stimulate the spinal cord, which can help restore some motor and sensory functions after a spinal cord injury. Unlike other treatments that may focus solely on pain relief, SCS has shown potential in improving movement and autonomic functions, such as blood pressure regulation, when combined with rehabilitation exercises.678910

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

Research shows that epidural spinal cord stimulation can effectively manage chronic pain in various conditions, such as reflex sympathetic dystrophy and failed back surgery syndrome, with many patients experiencing significant pain relief. Although the studies focus on pain management, the positive outcomes suggest potential benefits for spinal cord injury treatment, especially in carefully selected patients.89111213

Who Is on the Research Team?

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

David Darrow, MD MPH

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults over 22 with stable, motor-complete paraplegia due to spinal cord injury between C6 and T10. Participants must have had the injury for over a year, be medically stable, able to consent, and commit to all appointments. Excluded are those with certain health risks or conditions that complicate surgery or rehabilitation.

Inclusion Criteria

Willing to attend all scheduled appointments
My reflexes below my injury site work.
I have stable paralysis affecting my lower limbs.
See 6 more

Exclusion Criteria

I need opioids for pain or have pain that might stop me from fully joining in the rehab program.
Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgement of the principal investigator
I have a spinal fracture that has not yet healed.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive epidural spinal cord stimulation to optimize parameter settings for volitional movement and autonomic function

12 months
Monthly visits for assessment and optimization

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Epidural Spinal Cord Stimulation
Trial Overview The study tests optimizing epidural spinal cord stimulation settings to restore voluntary leg movement in people with paraplegia. It also looks at improvements in autonomic functions like blood pressure control related to spinal cord injuries.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Epidural Spinal Cord StimulationExperimental Treatment1 Intervention
Epidural Spinal Cord 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+

Minnesota Office of Higher Education

Collaborator

Trials
6
Recruited
280+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials
77
Recruited
355,000+

Hennepin County Medical Center, Minneapolis

Collaborator

Trials
22
Recruited
12,300+

Hennepin Healthcare Research Institute

Collaborator

Trials
94
Recruited
77,100+

Published Research Related to This Trial

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]
Percutaneous epidural stimulation for intractable pain was performed on 20 patients with no major complications, demonstrating its safety and simplicity compared to traditional methods.
The technique allowed for a trial period to assess pain relief, with 7 out of 8 patients experiencing long-term pain relief for up to 2 years, suggesting its efficacy as an alternative to dorsal column stimulator implantation.
Percutaneous epidural stimulation of the spinal cord for relief of pain. Long-term results.Urban, BJ., Nashold, BS.[2004]
Epidural spinal cord stimulation (SCS) is an effective treatment for neuropathic pain conditions like complex regional pain syndrome and chronic radiculopathy, particularly after conservative therapies have failed.
Successful use of epidural SCS requires careful patient selection and should be part of a comprehensive treatment plan, implemented only in specialized centers to manage potential complications.
[Epidural spinal cord stimulation for therapy of chronic pain. Summary of the S3 guidelines].Tronnier, V., Baron, R., Birklein, F., et al.[2021]

Citations

Epidural spinal cord stimulation in the management of reflex sympathetic dystrophy. [2018]
Percutaneous epidural stimulation of the spinal cord for relief of pain. Long-term results. [2004]
[Epidural spinal cord stimulation for therapy of chronic pain. Summary of the S3 guidelines]. [2021]
Treatment of chronic pain by epidural spinal cord stimulation: a 10-year experience. [2011]
Alternate Intraspinal Targets for Spinal Cord Stimulation: A Systematic Review. [2022]
The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. [2022]
Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry. [2019]
The Aarhus Neuromodulation Database. [2022]
A report of paraparesis following spinal cord stimulator trial, implantation and revision. [2011]
10.United Statespubmed.ncbi.nlm.nih.gov
Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]
11.United Statespubmed.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]
Successful spinal cord stimulation for neuropathic below-level spinal cord injury pain following complete paraplegia: a case report. [2019]
Beyond treatment of chronic pain: a scoping review about epidural electrical spinal cord stimulation to restore sensorimotor and autonomic function after spinal cord injury. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security