70 Participants Needed

Spinal Cord Epidural Stimulation for Spinal Cord Injury

CH
Overseen ByCharles Hubscher, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Louisville
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 incorporate critical cross viscero-visceral intersystem interactions to 1) investigate in a controlled laboratory setting and then with mobile at-home monitoring the extent, severity, and frequency of occurrence of autonomic dysreflexia with respect to daily bladder and bowel function, in conjunction with identifying potential underlying mechanisms by examining urinary biomarkers for several specific vasoactive hormones, and 2) to regulate cardiovascular function therapeutically as part of bladder and bowel management using spinal cord epidural stimulation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have an implanted pump, you would not be eligible to participate.

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

Research shows that spinal cord epidural stimulation can help restore movement and improve autonomic functions (like blood pressure regulation) after spinal cord injuries. It has also been used successfully to manage chronic pain, suggesting its potential for broader applications.12345

Is spinal cord epidural stimulation generally safe for humans?

Spinal cord epidural stimulation has been used for decades and is generally considered safe, but there are some risks. Rare complications include spinal cord injury, infection, and equipment failure. Most issues are related to surgical site infection and hardware malfunction, and serious neurological effects are uncommon.678910

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

Spinal cord epidural stimulation is unique because it uses electrical impulses to reactivate dormant spinal circuits, potentially improving motor function after a spinal cord injury. Unlike other treatments, it directly targets the spinal cord through implanted electrodes, offering a novel approach to enhance recovery.12111213

Research Team

CH

Charles Hubscher, PhD

Principal Investigator

University of Louisville

Eligibility Criteria

This trial is for adults with spinal cord injuries who have issues with bladder and bowel control. Participants must use intermittent catheterization and not be pregnant, ventilator-dependent, or have a colostomy bag. They shouldn't have had certain bladder treatments like Botox injections or surgery.

Inclusion Criteria

You have had a Medtronic scES array implanted before.
I have issues controlling my bladder and bowel due to nerve problems.
I use a catheter sometimes to help empty my bladder.
See 6 more

Exclusion Criteria

You need to use a ventilator to help you breathe for Arms 1 and 2.
I have had Botox injections in my bladder or bladder surgery before.
Arms 1 and 2: Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spinal cord epidural stimulation for maintenance of blood pressure and heart rate during bladder and bowel management

6 months
80 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Spinal Cord Epidural Stimulation
Trial OverviewThe study tests how well spinal cord epidural stimulation can manage high blood pressure and improve bladder and sexual function after injury. It involves controlled lab assessments and at-home monitoring to evaluate the therapy's effectiveness.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Cardiovascular spinal cord epidural stimulationExperimental Treatment1 Intervention
The purpose of this arm is to use spinal cord epidural stimulation for maintenance of blood pressure and heart rate in the lab during cystometry (bladder filling) and anorectal filling (bowel distension) and in the at-home setting for maintenance of normative blood pressure and heart rate that can be triggered from bladder filling and during bowel evacuation.
Group II: Measure symptomatic indices of autonomic dysreflexiaActive Control1 Intervention
The purpose of this arm is to systematically measure symptomatic indices of autonomic nervous system activation and corresponding cardiovascular changes in persons with spinal cord injuries during bladder filling and bowel stimulation.

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

🇺🇸
Approved in United States as Spinal Cord Stimulation for:
  • Respiratory dysfunction in spinal cord injury
  • Pain management
🇪🇺
Approved in European Union as Epidural Spinal Cord Stimulation for:
  • Chronic pain
  • Respiratory complications in spinal cord injury
🇨🇦
Approved in Canada as Electrical Spinal Cord Stimulation for:
  • Spinal cord injury rehabilitation
  • Neuropathic pain

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials
353
Recruited
76,400+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Findings from Research

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]
Epidural spinal cord stimulation was effective in controlling pain for 40% of the 121 patients studied, with a mean follow-up of 40 months, particularly benefiting those with pain from conditions like arachnoiditis and multiple sclerosis.
While the treatment showed promise for many, it was less effective for certain types of pain, such as that from cauda equina injury or primary bone diseases, and complications like infection and electrode issues were noted, indicating the need for careful patient selection.
Treatment of chronic pain by epidural spinal cord stimulation: a 10-year experience.Kumar, K., Nath, R., Wyant, GM.[2011]
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]

References

[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]
Effects of percutaneously-implanted epidural stimulation on cardiovascular autonomic function and spasticity after complete spinal cord injury: A case report. [2023]
Recovery of volitional movement with epidural stimulation after "complete" spinal cord injury due to gunshot: A case report and literature review. [2023]
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]
A report of paraparesis following spinal cord stimulator trial, implantation and revision. [2011]
The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. [2022]
Postsurgical pathologies associated with intradural electrical stimulation in the central nervous system: design implications for a new clinical device. [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
New Onset Tinnitus after High-Frequency Spinal Cord Stimulator Implantation. [2020]
Epidural spinal cord stimulation for motor recovery in spinal cord injury: A systematic review. [2021]
Experience with spinal cord stimulation (SCS) in the management of chronic pain in a traumatic transverse lesion syndrome. [2019]
Evaluation of optimal electrode configurations for epidural spinal cord stimulation in cervical spinal cord injured rats. [2018]