NCT07121712 Navigated cTBS for the Treatment of Generalized Anxiety Disorder
| NCT ID | NCT07121712 |
| Status | Recruiting |
| Phase | — |
| Sponsor | WANG KAI |
| Condition | Generalized Anxiety Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-09-09 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-09-09 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to investigate the effectiveness of a non-invasive brain stimulation technique called continuous Theta Burst Stimulation (cTBS) for treating Generalized Anxiety Disorder (GAD). The researchers will use a neuronavigation system, which acts like a GPS for the brain based on a participant's own MRI scan, to guide the stimulation to a specific target in the brain's auditory association cortex. This area is involved in processing information and may play a role in anxiety. Participants who enroll will be randomly assigned to one of two groups. One group will receive active cTBS treatment, while the other will receive a sham (placebo) stimulation that feels similar but has no therapeutic effect. The treatment will be given three times a day for seven consecutive days. Before and after the treatment period, all participants will complete clinical questionnaires to measure their anxiety and related symptoms. They will also undergo Magnetic Resonance Imaging (MRI) scans to help researchers understand how cTBS affects brain activity. A follow-up assessment will be conducted two weeks after the treatment ends to check on symptoms.
Eligibility Criteria
Inclusion Criteria: 1. Diagnosis of Generalized Anxiety Disorder (GAD) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), confirmed by at least two psychiatrists. 2. Hamilton Anxiety Rating Scale (HAMA) score \> 14. 3. Age between 18 and 60 years. 4. More than 5 years of education. 5. Right-handed. 6. Normal or corrected-to-normal visual acuity. 7. Able to cooperate with the completion of all experimental procedures. 8. Willing and able to provide written informed consent. Exclusion Criteria: 1. Presence of other psychiatric disorders, such as substance abuse, schizophrenia, schizoaffective disorder, hysteria, or autism. 2. Presence of severe neurological diseases (e.g., stroke), or any personal or family history of epilepsy or seizures. 3. Presence of severe somatic diseases, such as severe heart, liver, or renal insufficiency. 4. Pregnant or lactating women. 5. Contraindications to Transcranial Magnetic Stimulation (TMS) or Magnetic Resonance Imaging (MRI), such as the presence of a cardiac pacemaker, cochlear implant, cerebrovascular metal stent, or metal dentures. 6. Inability to cooperate with experimental procedures due to conditions such as depressive stupor or severe claustrophobia.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07121712 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Generalized Anxiety Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07121712 currently recruiting?
Yes, NCT07121712 is actively recruiting participants. Contact the research team at wangkai1964@126.com for enrollment information.
Where is the NCT07121712 trial being conducted?
This trial is being conducted at Hefei, China, Hefei, China.
Who is sponsoring the NCT07121712 clinical trial?
NCT07121712 is sponsored by WANG KAI. The trial plans to enroll 40 participants.
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