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:
2025-12-24 @ 1:53 PM
Ignite Modification Date:
2025-12-24 @ 1:53 PM
NCT ID:
NCT06237595
Eligibility Criteria:
Inclusion Criteria:
* Female patients above 18 years, with a clinical diagnosis of fibromyalgia according to 2016 ACR fibromyalgia diagnostic criteria, will be included in this study.
Exclusion Criteria:
* \- Pregnant, and postmenopausal women.
* Patients with any medical disorder including: cardiovascular, pulmonary, renal, hepatic, endocrine, blood, gastrointestinal, diabetes, neuropathic disorders, psychiatric disorders (for example; post traumatic stress disorder (PTSD), mania, psychosis, suicidality, bipolar/schizophrenia/autism spectrum disorders) and/or neurodegenerative disorders (e.g., Parkinson's, Alzheimer's, Huntington's disease).
* Cancer diagnosis within the preceding 5 years.
* Planned surgery.
* Use of other medical devices electrically active for example a cardiac pacemaker, or TENS for chronic pain.
* Electrocardiogram (ECG) abnormalities.
* History of Electroconvulsive therapy (ECT).
* Symptomatic orthostatic hypotension, or history of recurrent vagal syncope.
* History of vagotomy.
* Uncontrolled hypertension or hypotension.
* Documented sleep apnea.
* Other rheumatic diseases like (Rheumatoid Arthritis, Systemic lupus erythematosus, Seronegative spondyloarthropathies).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06237595
Study Brief:
Protocol Section:
NCT06237595