Spinal Cord Epidural Stimulation for Spinal Cord Injury
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?
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.35111213
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
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo spinal cord epidural stimulation for maintenance of blood pressure and heart rate during bladder and bowel management
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Spinal Cord Epidural Stimulation (Neurostimulation Device)
Spinal Cord Epidural Stimulation is already approved in United States, European Union, Canada for the following indications:
- Respiratory dysfunction in spinal cord injury
- Pain management
- Chronic pain
- Respiratory complications in spinal cord injury
- Spinal cord injury rehabilitation
- Neuropathic pain