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Navigated cTBS for the Treatment of Generalized Anxiety Disorder

RecruitingNAAges 18 Years - 60 YearsAllWANG KAI
NCT07121712 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Mapsd Continuous Theta Burst Stimulation
  • Sham Navigated Continuous Theta Burst Stimulation
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Where

2 sites
Anhui Medical University
Hefei, China
Anhui Medical University
Hefei, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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