Auricular Neurostimulation for Chronic Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates how a device worn on the ear might help people with chronic pain. It uses gentle electrical stimulation, known as Transcutaneous Auricular Neurostimulation, to potentially alter how the brain perceives pain and manage withdrawal symptoms. Participants will receive either real or sham stimulation to compare effects. This trial suits those who have experienced pain for more than half the days in the last six months and are willing to reduce their opioid use by at least 10%. Participants will stay in a research center for a few days for close monitoring. As an unphased trial, this study offers a unique opportunity to explore innovative pain management solutions.
Will I have to stop taking my current medications?
You will need to reduce your pain medication by at least 10% as part of the study. The protocol does not specify stopping other medications, but you must not be taking benzodiazepines or have a high opioid dose.
What prior data suggests that this auricular neurostimulation device is safe for reducing chronic pain?
Research has shown that transcutaneous auricular neurostimulation (tAN) is generally safe. Studies have found that this technique usually causes only mild and short-lasting side effects. In trials involving individuals with knee osteoarthritis, tAN was considered a safe treatment option, potentially serving as a good alternative to more invasive procedures.
The FDA has already approved the device used for this treatment, further supporting its safety. Any side effects are typically temporary and not serious. Participants can adjust the stimulation level to maintain comfort during the procedure.
Overall, evidence suggests that tAN is a well-tolerated option for managing pain, with minimal risk to participants.12345Why are researchers excited about this trial?
Researchers are excited about transcutaneous auricular neurostimulation (tAN) for chronic pain because it offers a novel, non-invasive approach that differs from traditional pain management methods like medications or invasive procedures. Unlike typical treatments that often come in the form of pills or injections, tAN uses a wearable device to deliver electrical stimulation to the ear, targeting specific nerves associated with pain relief. This innovative delivery method could potentially reduce side effects associated with conventional pain medications, providing a safer and more comfortable option for those suffering from chronic pain.
What evidence suggests that this device is effective for chronic pain?
Research has shown that transcutaneous auricular neurostimulation (tAN) can help reduce chronic pain. This trial will compare active tAN stimulation with a sham version to evaluate its effectiveness. The method stimulates nerves in the ear and has made a noticeable difference in managing pain. It targets the vagus and trigeminal nerves, which play important roles in processing pain signals in the brain. For individuals with long-term pain conditions, tAN has effectively reduced pain symptoms. This non-invasive treatment does not involve surgery or needles, making it more appealing. Overall, previous patients reported improvements in their pain levels with tAN therapy.678910
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 with chronic pain, who are on opioid medication and willing to reduce their dose by at least 10%. They must not have a history of seizures, neurological diseases, or ear problems. Participants should test negative for illicit drugs and nonprescribed opioids but positive for prescribed ones. Pregnant women or those at risk of pregnancy without proper contraception are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either active or sham transcutaneous auricular neurostimulation for two days, with four hours of stimulation each day.
Monitoring
Participants are monitored for withdrawal symptoms and complete questionnaires, sensory testing, and MRI scans.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including completion of questionnaires and MRI.
What Are the Treatments Tested in This Trial?
Interventions
- Transcutaneous Auricular Neurostimulation
Transcutaneous Auricular Neurostimulation is already approved in United States, European Union for the following indications:
- Chronic pain
- Opioid withdrawal
- Irritable bowel syndrome
- Chronic pain
- Temporomandibular disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Medical Branch, Galveston
Lead Sponsor
Medical University of South Carolina
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator