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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

• Hamilton Anxiety Rating Scale (HAMA) score \> 14.

• Age between 18 and 60 years.

• More than 5 years of education.

• Right-handed.

• Normal or corrected-to-normal visual acuity.

• Able to cooperate with the completion of all experimental procedures.

• Willing and able to provide written informed consent.

Locations
Other Locations
China
Anhui Medical University
RECRUITING
Hefei
Anhui Medical University
RECRUITING
Hefei
Contact Information
Primary
Kai Wang, MD
wangkai1964@126.com
+86-0551-62923704
Backup
Tongjian Bai, MD
baiyunong1990@163.com
Time Frame
Start Date: 2025-09-09
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 40
Treatments
Experimental: Experimental: Navigated cTBS
Participants will receive active continuous Theta Burst Stimulation (cTBS) guided by a neuronavigation system to the left auditory association cortex. Treatment will be administered three times a day for seven consecutive days.
Sham_comparator: Sham Comparator: Sham cTBS
Participants will undergo a sham cTBS procedure using a placebo coil that mimics the sound and sensation of the active stimulation but delivers no effective magnetic field. The procedure, including targeting and duration, is identical to the active group to maintain blinding.
Related Therapeutic Areas
Sponsors
Leads: WANG KAI

This content was sourced from clinicaltrials.gov