Navigated cTBS treatment for generalized anxiety disorder

Efficacy and Neural Mechanisms of Navigated Continuous Theta Burst Stimulation (cTBS) for Generalized Anxiety Disorder (GAD)

This will test whether neuronavigation-guided continuous theta burst stimulation (cTBS) to a specific brain area can reduce anxiety in adults with generalized anxiety disorder.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Anhui Medical University (Academic / other)
• Locations: 2 sites (Hefei, Anhui and 1 other locations)
• Trial ID: NCT07121712 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–60 with DSM-5 generalized anxiety disorder, HAMA score >14, right-handed, able to undergo MRI and TMS, and able to give informed consent are the intended participants.

Not a fit: People with other major psychiatric disorders, a history of seizures, severe medical illnesses, pregnancy or lactation, contraindications to MRI or TMS, or who are unable to complete the procedures are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could offer a non-drug, targeted option to reduce anxiety symptoms in some people with GAD.

How similar studies have performed: Some previous TMS studies for anxiety and related disorders have shown promise, but neuronavigated cTBS to this auditory association cortex target is relatively novel with limited prior data.

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.

Where this trial is running

Hefei, Anhui and 1 other locations

• Anhui Medical University — Hefei, Anhui, China (Recruiting)
• Anhui Medical University — Hefei, Anhui, China (Recruiting)

Study contacts

• Study coordinator: Kai Wang, MD

Conditions Generalized Anxiety Disorder; Continuous Theta Burst Stimulation; Transcranial Magnetic Stimulation; Neuronavigation; Magnetic Resonance Imaging