Status:
COMPLETED
Scrambler Trial for Pain in NMOSD
Lead Sponsor:
Johns Hopkins University
Conditions:
Neuromyelitis Optica
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A novel technology called Scrambler Therapy is a non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of C fibers with the intent of re-organizing maladaptive sign...
Detailed Description
Neuromyelitis optica spectrum disorder (NMOSD) is a rare autoimmune disease of the central nervous system that disproportionately affects non-Caucasians and females,1,2 and has a worldwide prevalence ...
Eligibility Criteria
Inclusion
- Be 18 years of age or older
- Have the presence of persistent CNP rated at a level of 4 or higher on an 11-point numeric rating scale (NRS); persistent pain is defined as presence for \>3 months
- Patients must be stable in their disease, such that they have had no spinal cord relapses with the last 6 months
- Patients may use any combination of standard of care medications for pain treatment, to include anti-epileptic, antidepressant, opioid or non-steroidal anti-inflammatory medications, with no adjustments to the regimen within 30 days of enrollment.
- Aquaporin-4 (AQP4)-antibody positive or negative, or untested, but otherwise meeting criteria for diagnosis of NMOSD.
Exclusion
- A concomitant diagnosis of peripheral neuropathy
- An ongoing concomitant central neurologic disorder
- Pain that is referable to a spinal cord lesion that starts above the 4th vertebral disc of the cervical spinal cord because FDA device clearance allows for treatment below the neck
- Use of an investigational agent for pain control within 30 days of enrollment
- Pregnant or breastfeeding women
- Those with cognitive or mental incompetency
- Patients with implantable devices
Key Trial Info
Start Date :
February 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03452176
Start Date
February 21 2018
End Date
August 29 2019
Last Update
May 5 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins University
Baltimore, Maryland, United States, 21287