Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT07121712

Navigated cTBS for the Treatment of Generalized Anxiety Disorder

Led by WANG KAI · Updated on 2025-09-10

40

Participants Needed

2

Research Sites

50 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Navigated cTBS for the Treatment of Generalized Anxiety Disorder

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Generalized Anxiety Disorder (GAD) confirmed by at least two psychiatrists according to DSM-5
  • Hamilton Anxiety Rating Scale (HAMA) score greater than 14
  • Age between 18 and 60 years
  • More than 5 years of education
  • Right-handed
  • Normal or corrected-to-normal vision
  • Able to cooperate with all experimental procedures
  • Willing and able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Other psychiatric disorders such as substance abuse, schizophrenia, schizoaffective disorder, hysteria, or autism
  • Severe neurological diseases like stroke or any personal or family history of epilepsy or seizures
  • Severe somatic diseases including severe heart, liver, or kidney insufficiency
  • Pregnant or lactating women
  • Contraindications to Transcranial Magnetic Stimulation (TMS) or MRI, including cardiac pacemaker, cochlear implant, cerebrovascular metal stent, or metal dentures
  • Inability to cooperate with procedures due to conditions like depressive stupor or severe claustrophobia

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Anhui Medical University

Hefei, Anhui, China, 230000

Actively Recruiting

2

Anhui Medical University

Hefei, Anhui, China, 230000

Actively Recruiting

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Research Team

K

Kai Wang, MD

CONTACT

T

Tongjian Bai, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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