NCT06475040

TMS for Anxiety and Trauma-related Disorders

Accelerated Intermittent Theta Burst Stimulation to a Novel DLPFC Target for Anxiety and Trauma-related Disorders: a Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The present pilot study will apply accelerated intermittent theta burst stimulation (aiTBS) to a novel transcranial magnetic stimulation (TMS) target for anxiety derived via causal network mapping.

Detailed description

Anxiety-related disorders represent the most common class of mental-health disorders and are associated with high rates of non-response and relapse to current treatments. Transcranial magnetic stimulation (TMS) applied to the dorsolateral prefrontal cortex (dlPFC) has been shown to reduce anxiety comorbid with major depressive disorder (MDD). However, anxiety-specific targets have received insufficient attention. An anxiety specific transcranial magnetic stimulation (TMS) target was recently derived via causal network mapping and was shown to reduce anxiety versus depression symptoms to a greater extent than the conventional dlPFC target in an MDD sample with comorbid anxiety. While potentially promising, this target has yet to be trialed in an anxiety-related disorder sample. The current open-label study will be the first to evaluate the preliminary effectiveness and safety of this novel right dorsomedial prefrontal cortex (dmPFC) TMS target. MRI-guided neuronavigation will be used to locate this target in each participant. An accelerated intermittent theta-burst (aiTBS) dosing regimen will be used. Based on a 90% resting motor threshold (adjusted for cortical depth), 50 sessions of iTBS will be administered (1800 pulses per session, with a 50-minute inter-session interval) and delivered in a schedule of 10 sessions per day for 5 consecutive days. Clinical assessments and resting-state functional MRI scans will be conducted before and after aiTBS. Heart rate variability (HRV) and eye-movement measures will be collected before and after aiTBS.

Conditions

• Anxiety Symptoms
• Anxiety Disorders

Interventions

Type	Name	Description
DEVICE	transcranial magnetic stimulation	non-invasive form of brain stimulation accelerated intermittent theta burst stimulation (aiTBS)

Timeline

• Start date: 2024-06-19
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2024-06-26
• Last updated: 2024-07-10

Locations

1 site across 1 country: China