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 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT06638450
Eligibility Criteria:
Inclusion Criteria:
Subjects will be eligible for this study if they:
1. are experiencing anxiety as evidenced by a BAI-C score of at least 8 (no symptoms = 0-7; mild = 8-15; moderate = 16-25; severe = 26-63), and/or a C-BDI-II score of at least 14 (no symptoms = 0-13, mild = 14-19; moderate = 20-28; severe = 29-63);
2. have symptoms that have persistent for more than 3 months;
3. are able to provide informed consent for participation, and complete treatments and questionnaires as scheduled; and
4. have no suicidal ideation, as evidenced by "no" answers or a score of \<3 for all questionnaires of the Columbia-Suicide Severity Rating Scale (C-SSRS).
Exclusion Criteria:
Subjects will be excluded if they:
1. have unstable systemic medical conditions that may limit their participation in the study, for example, severe liver, cardiovascular, or kidney impairment; gastrointestinal or endocrine dysfunction; malignancy; autoimmune disease; acute infectious disease; or any conditions with unstable vital signs or require intensive hospitalization;
2. have bipolar or psychotic disorder (e.g. schizophrenia);
3. have a history of brain injury or surgery;
4. have alcohol abuse or substance abuse;
5. are pregnant or in lactation, or intend to conceive;
6. have heart pacemaker or other metal devices implanted in the body;
7. have concurrent or use of drug treatment for anxiety/depression in the previous 6 months;
8. have treatment with acupuncture or brain stimulation in the previous 6 months;
9. have a history of epilepsy;
10. have a condition of bleeding tendency, or coagulopathy, or currently receiving anti-coagulant treatment; or
11. involved in other interventional clinical studies in the last 3 months or any relevant condition potentially interfering with study evaluation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
22 Years
Study:
NCT06638450
Study Brief:
Protocol Section:
NCT06638450