Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2024-06-19
2025-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open-label aiTBS to novel right dmPFC TMS anxiety target
transcranial magnetic stimulation
non-invasive form of brain stimulation accelerated intermittent theta burst stimulation (aiTBS)
Interventions
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transcranial magnetic stimulation
non-invasive form of brain stimulation accelerated intermittent theta burst stimulation (aiTBS)
Eligibility Criteria
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Inclusion Criteria
2. Male or female between 18 and 60 years old.
3. Right-handed.
4. Can understand and sign an informed consent document.
5. Beck Anxiety Inventory (BAI) score of 16 or higher.
6. On a stable medication/psychotherapy regimen for at least 6 weeks prior to baseline visit and throughout the duration of the study.
7. In good general health, as ascertained by medical history.
8. Pharmacological treatment resistance or psychotherapeutic treatment resistance.
Exclusion Criteria
2. History of brain surgery and epilepsy.
3. Presence of metallic foreign bodies, such as cardiac pacemakers and stents.
4. Any medical condition or medication that increases the risk of seizures.
5. Pregnancy.
6. Intellectual disability.
7. Current severe somatic disease, such as cancer, heart failure, pneumonia, etc.
8. Severe claustrophobia that prevents the use of MRI.
18 Years
60 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Shanghai Mental Health Center
OTHER
Responsible Party
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Principal Investigators
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Huiru Cui, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Locations
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Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HRCui
Identifier Type: -
Identifier Source: org_study_id
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