Clinical trial for Fibromyalgia
Official title Auricular Neuromodulation in Veterans With Fibromyalgia
ClinicalTrials.gov ID: NCT06415591
What this study is testing
- What it's testing
- This study aims to see if a specific ear treatment can reduce pain and improve daily function for people with fibromyalgia. It also looks at how the treatment affects brain activity.
- Who it's for
- The study is looking for veterans who have fibromyalgia.
- What's involved
- Participants will receive electrical stimulation to the outer ear. They will also have brain scans to check how their brain activity changes.
- Time commitment
- The source text does not specify the total duration or number of visits required.
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older; for those who participate in the MRI portion, age 20-60 years old (limit specifically set for participants receiving an MRI...
- For those who participate in the MRI portion, right-handedness, to provide consistency in brain structure and function (limit specifically set for...
- For those who participate in the MRI portion, the ability to safely tolerate MRI
- Diagnosis of fibromyalgia by the American College of Rheumatology 2016 criteria69
- Pain score of 4 or greater on DVPRS51 in the 3 months prior to enrollment
You likely can't join if
- Pregnancy (self-reported)
- History of seizures or neurologic conditions that alter the brain
- Claustrophobia, MRI-incompatible implants, or other conditions incompatible with MRI (only for those who participate in MRI)
- History of uncontrolled psychiatric illness, autoimmune disease that leads to pain, or skin conditions that can increase risk of infection at PENFS...
See the full eligibility criteria
- Age 18 years or older; for those who participate in the MRI portion, age 20-60 years old (limit specifically set for participants receiving an MRI scan; limit set to minimize brain structural changes due to aging)
- For those who participate in the MRI portion, right-handedness, to provide consistency in brain structure and function (limit specifically set for participants receiving an MRI scan
- For those who participate in the MRI portion, the ability to safely tolerate MRI
- Diagnosis of fibromyalgia by the American College of Rheumatology 2016 criteria69
- Pain score of 4 or greater on DVPRS51 in the 3 months prior to enrollment
- Intact skin in area of PENFS treatment
- Pregnancy (self-reported)
- History of seizures or neurologic conditions that alter the brain
- Claustrophobia, MRI-incompatible implants, or other conditions incompatible with MRI (only for those who participate in MRI)
- History of uncontrolled psychiatric illness, autoimmune disease that leads to pain, or skin conditions that can increase risk of infection at PENFS site
The study team makes the final eligibility decision.
Where it is enrolling
- Decatur, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Decatur, Georgia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.