Mapsd Dual-target cTBS (Auditory Cortex and M1) for Generalized Anxiety Disorder

Condition(s) studied

Investigational drug(s) / intervention(s)

Active Dual-target cTBS: A non-invasive brain stimulation technique using a MagStim Rapid2 stimulator with a 70mm air-cooled figure-of-eight coil. Targets: 1. Left auditory association cortex (MNI: -62, -40, 10), located using Brainsight neuronavigation. 2. Primary Motor Cortex (M1), determined by the resting motor threshold (RMT) hotspot. Protocol: Stimulation of the auditory cortex is immediately followed by M1 stimulation. Each target receives a standard cTBS protocol (3-pulse 50 Hz bursts repeated at 5 Hz, total 600 pulses, 40s duration). Dosing: Delivered at 100% RMT. Sessions are repeated 3 times/day with 15-min intervals for 7 days.

Sham Dual-target cTBS: A placebo procedure using an inert sham coil that is identical in appearance and sound to the active coil but does not deliver a significant magnetic field to the cortex. Blinding: The procedure includes identical neuronavigation setup, dual-target coil positioning (Auditory Cortex then M1), duration, and treatment schedule (3 times/day for 7 days) to maintain the blind.

Study summary

The purpose of this study is to investigate the effectiveness of a dual-target 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, to guide the stimulation to two specific targets: the left auditory association cortex and the primary motor cortex (M1).

Participants will be randomly assigned to one of two groups. One group will receive active dual-target 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 undergo Magnetic Resonance Imaging (MRI) scans to help researchers understand how cTBS affects brain activity.

Eligibility

Primary outcome measure(s)

• Change from Baseline in Hamilton Anxiety Rating Scale (HAMA) Score — Baseline (Day 1), Post-intervention (Day 9), and 2-week Follow-up
  The HAMA is a 14-item, clinician-administered scale used to assess the severity of anxiety symptoms. Total scores range from 0 to 56, with higher scores indicating more severe anxiety. The change in total score from baseline to post-intervention and follow-up will be assessed.
• Change from Baseline in Resting-State Neural Activity — Baseline (Day 1) and Post-intervention (Day 9)
  Changes in resting-state brain activity will be measured by functional magnetic resonance imaging (fMRI). Analyses will examine neural activity (ALFF/ReHo) and functional connectivity dynamics related to the stimulation targets (left auditory cortex and M1) and brain circuits implicated in anxiety.

Trial sites (1)

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