Neuroimage-guided Dual-target Continuous Theta Burst Stimulation for Generalized Anxiety Disorder

Condition(s) studied

Investigational drug(s) / intervention(s)

Continuous theta-burst stimulation: cTBS targets two regions: the dorsolateral prefrontal cortex (dlPFC) and the M1 area. Before the first treatment, each participant's resting motor threshold (RMT) will be determined using a five-step procedure for the primary motor cortex. RMT is defined as the minimum intensity required to elicit a motor response greater than 50 µV in at least 5 out of 10 consecutive trials in the right first dorsal interosseous muscle. Participants will then undergo daily cTBS treatment three times a day for 7 consecutive days. Each stimulation session lasts 40 seconds, consisting of triplets of 50 Hz theta-burst stimulation repeated at 5 Hz, delivering a total of 600 pulses. Stimulation of the dlPFC target will be immediately followed by stimulation of the M1 target. To achieve cumulative aftereffects, the protocol will be repeated three times per day (a total of 3600 pulses/day) with two 15-minute breaks between sessions, timed with a stopwatch.

sham continuous theta-burst stimulation: The treatment pattern for the sham continuous theta-burst stimulation was similar to that for real stimulation. The sham coil is identical in appearance to the active coil, but it only produces sounds and sensations similar to those of the active coil on the scalp without generating a current, preventing participants from identifying their group assignment.

Study summary

The aim of this clinical trial was to determine whether image-guided dual-target cTBS is effective for anxiety disorders. The main questions it aims to answer are:

1. Does dual-target cTBS improve patients' anxiety symptoms?
2. Does dual-target cTBS improve patients' somatization symptoms?
3. Researchers will compare cTBS real and sham stimulation to determine whether cTBS is effective in treating anxiety disorders.

Participants will:

1. Received either cTBS treatment or sham stimulation for 7 consecutive days
2. Psychological assessment and MRI scan were performed before treatment, within 2 days, 2 weeks and 1 month after treatment
3. Adverse reactions during the experiment were recorded

Eligibility

Primary outcome measure(s)

• Hamilton Anxiety Rating Scale (HAMA) — 0week, 1week, 3week, 5week
  the change of anxiety symptoms assessed by HAMA scale(Hamilton Anxiety Scale) will constitute the major research outcome measure, to assess response to tACS. HAMA scale scores range from 0 to 56 points, the higher the score indicates the more serious anxiety symptoms

Trial sites (1)

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