Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome During Opioid Medication Reduction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests if a nerve-stimulating device can help patients with severe RLS reduce their opioid use without worsening their symptoms.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it requires that you have been on a stable dose of prescription opioids for at least 3 months before joining the study.
Is Noninvasive Peripheral Nerve Stimulation (NPNS) generally safe for humans?
Peripheral nerve stimulation (PNS), which is similar to NPNS, has been used for pain treatment since the 1960s. While there is a high rate of complications, these are usually minor and can often be fixed with simple outpatient procedures. Overall, PNS is considered safe, but improvements in equipment specifically designed for PNS could reduce complications.12345
How is Noninvasive Peripheral Nerve Stimulation (NPNS) different from other treatments for neuropathic pain?
Noninvasive Peripheral Nerve Stimulation (NPNS) is unique because it uses a simple, external device to deliver low-frequency electrical stimulation directly to the skin, unlike other treatments that may require surgical implantation. This makes it a less invasive option for managing chronic pain.678910
What data supports the effectiveness of the treatment Noninvasive Peripheral Nerve Stimulation (NPNS)?
Who Is on the Research Team?
Jonathan D Charlesworth, PhD
Principal Investigator
Noctrix Health, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in Phase
Participants undergo a 1-2 week run-in phase to allow resolution of opioid withdrawal symptoms unrelated to RLS
Assessment Phase
A 1-week assessment phase to evaluate if RLS symptoms have increased after opioid dose reduction
Extension Phase (optional)
Participants who tolerate both step-downs have the option of an extension phase involving a third step-down with the same format
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Noninvasive Peripheral Nerve Stimulation (NPNS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Noctrix Health, Inc.
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator