"Epidural Spinal Cord Stimulation: Addressing Spasticity and Motor Function"

Launched by KESSLER FOUNDATION · Jun 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called epidural spinal cord stimulation to help people with severe spasticity, which is when muscles tighten uncontrollably, often affecting those with spinal cord injuries. The researchers want to see if this method can reduce spasticity more effectively and with fewer side effects compared to a device called a baclofen pump, which is another common treatment for this condition.

To participate in the trial, you need to be at least 18 years old and have a spinal cord injury that isn't getting worse. It's important that you're in stable health and have already been considered for a baclofen pump. However, certain conditions may prevent you from joining, such as being dependent on a ventilator, having untreated pain, or having other serious medical issues. If you qualify, you will receive detailed information about what to expect during the study, including any procedures and follow-ups. This trial is not yet recruiting participants, but it aims to provide valuable insights into new treatment options for managing spasticity.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. I must be at least 18 years of age
• • 2. I must have a non-progressive spinal cord injury (SCI)
• • 3. I have met the clinical criteria for an intrathecal baclofen pump
• • 4. I am in stable medical condition
• Exclusion Criteria:
• • 1. I must not be ventilator dependent
• • 2. I must not have untreated painful musculoskeletal dysfunction, fracture or pressure injury
• • 3. I must not have untreated psychiatric disorder or ongoing drug abuse, as determined by study staff
• • 4. I must not have cardiac, respiratory, bladder, renal or other untreated medical disorder unrelated to SCI
• • 5. I must not have had peripheral muscle Botox injections less than 12 months prior to implant
• • 6. I must not have a colostomy bag or urostomy
• • 7. I must not have any implanted pump (i.e., baclofen pump, pain pump, etc.) prior to randomization
• • 8. I must not be pregnant at the time of enrollment or planning to become pregnant during the time course of the study
• • 9. I must not have an active implantable device that may interfere with the epidural neurostimulator