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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT06912334
Eligibility Criteria:
Inclusion Criteria
* Women between 18-79 years old
* Women diagnosed with Fibromyalgia according to the ACR 2016 Revised Classification Criteria
* Moderate to high pain intensity according to analog pain scales (above 4 points over 10), for more than 6 months
* Cognitive function sufficient to understand the experiments and follow instructions
* Ability to read and understand all information on the device display.
* Ability to adjust the strength of the stimulation or give feedback regarding their response to the device (feeling tingling/pulsating/pain).
* Ability to comply with the recommended therapy regiment of 30 min per day.
* The ear electrode needs to fit the patient.
* Patients with physical or mental disabilities
* The patient must be able to use the device by themselves or
* The patients' caretaker can operate the device on the patient. In this case the patient --must still be able to give feedback regarding their response to the device
Exclusion Criteria
* Cardiac arrhythmias
* Pregnancy
* Serious mental disorder (dipolar disorder, schizophrenia etc.)
* Prior injury to the vagus nerve
* Individuals with scar tissue that may interfere with the stimulation
* Presence of an electrically or magnetically activated implant
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT06912334
Study Brief:
Protocol Section:
NCT06912334