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 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT06009159
Eligibility Criteria:
Inclusion Criteria:
1. Subject is 18 to 80 years old, including both male and female subjects.
2. Subject has a documented diagnosis of FM for at least three months. This requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation.
3. Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain to worst pain).
Exclusion Criteria:
1. Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICD device.
2. Subject has major psychiatric disorder required hospitalization in the last 3 months.
3. Subject has active infection at the site of device application.
4. Subject has recurrent syncope symptoms within the past three months.
5. Subject is pregnant.
6. Subject has had VNS treatment within the past two months.
.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06009159
Study Brief:
Protocol Section:
NCT06009159