Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT04115033
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be male and female Veterans age 20-60 with a diagnosis of fibromyalgia as diagnosed by a clinician, by chart review, and by the most recent American College of Rheumatology 2010 criteria for the diagnosis of fibromyalgia.
* Subjects must self-report consistent, daily pain (greater than 5 on the VAS) \>90 days.
* Subjects must have intact skin free of infection at the site of electrode placement.
* Subjects must be willing to participate and understand the consent.
* Subjects must be right-handed in order to provide consistency in brain structure and function.
Exclusion Criteria:
* Subjects must not be currently pregnant, since effects of fMRI and electrical current on the developing fetus are not well-known.
* Subjects must not have an implanted electrical device such as a vagal stimulator, pacemaker, or spinal pain pump, which are not compatible with MRI.
* Subjects must not have a history of seizures or neurologic condition that may alter the structure of the brain.
* Subjects must not have a history of drug abuse or severe, uncontrolled psychiatric illness such as schizophrenia or major depressive disorder with suicidal ideation.
* Subjects must not have psoriasis vulgaris or other skin conditions that may increase the risk of infection at the implantation site.
* Subjects must not have severe anxiety, claustrophobia, or other conditions that may prevent their ability to lie at rest in an MRI scanner. This will be determined after discussion with the patient regarding their own perceived ability to lie at rest in an MRI scanner without the use of additional sedating medications.
* Subjects must not introduce new medications or treatments for fibromyalgia symptoms during the course of the study to prevent confounding results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT04115033
Study Brief:
Protocol Section:
NCT04115033