Navigated cTBS treatment for generalized anxiety disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, triple-blind, sham-controlled trial will enroll 40 adults with DSM-5 generalized anxiety disorder and randomize them 1:1 to active or sham neuronavigated cTBS. Stimulation will target the left auditory association cortex using each participant's MRI and a Brainsight neuronavigation system, delivered three times daily for seven days at 100% resting motor threshold. Clinical questionnaires and MRI scans will be collected before and after the treatment period to measure symptom change and neural effects. The sham coil produces similar sounds and sensations but does not deliver effective stimulation to preserve blinding.

Why it matters

Who can join: the full rules

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.

Where it's running

• Anhui Medical University
  Hefei, Anhui, China Recruiting
• Anhui Medical University
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Kai Wang, MD
• Email: wangkai1964@126.com
• Phone: +86-0551-62923704

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.