Anxiety Disorders, Anxiety Symptoms
Conditions
Brief 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.
Interventions
DEVICEtranscranial magnetic stimulation
non-invasive form of brain stimulation accelerated intermittent theta burst stimulation (aiTBS)
Sponsors
Shanghai Mental Health Center
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder (PD), and/or post-traumatic stress disorder (PTSD) as defined by DSM-5 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
1. Substance use disorders, eating disorders, significant suicidal ideation, mental disorder due to a medical or neurocognitive condition, lifetime psychosis, bipolar disorder, developmental disorders. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Anxiety Inventory (BAI) | Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment. | The Beck Anxiety Inventory (BAI) is a 21-item self-report measure of anxiety symptom severity. Total scores range from 0 to 63, with higher scores indicating greater anxiety severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BAI Response | Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment. | BAI response was defined as a ≥50% reduction in Beck Anxiety Inventory (BAI) total score from baseline. Outcome values represent the number of participants who met this criterion at each assessment time point. |
| Hamilton Anxiety Rating Scale (HAMA) | Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment. | The Hamilton Anxiety Rating Scale (HAMA) is a clinician-administered measure of anxiety symptom severity. The scale consists of 14 items rated from 0 (not present) to 4 (severe), yielding total scores ranging from 0 to 56, with higher scores indicating greater anxiety severity. |
| Sheehan Disability Scale (SDS) | Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment. | The Sheehan Disability Scale (SDS) is a self-report measure of functional impairment across work/school, social, and family life domains. Total scores range from 0 to 30, with higher scores indicating greater functional impairment. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORHuiru Cui, Ph.D
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Participant flow
Recruitment details
Treatment-resistant anxiety patients seeking outpatient care at Shanghai Mental Health Center, the largest psychiatric hospital in Shanghai, China, were recruited. Fifteen participants consented to participate in this study between June 19th, 2024 and April 13th, 2025.
Pre-assignment details
15 participants were initially recruited. 3 participants were excluded from the final analysis: 2 withdrew following the first day of aiTBS due to perceived worsening of nightmares and headaches, and 1 was excluded after abruptly discontinuing a prescribed anxiety medication and initiating a new medication. 12 participants were included in the final analysis.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 36.7 years STANDARD_DEVIATION 11.2 |
| Beck Anxiety Inventory (BAI) | 25.42 points STANDARD_DEVIATION 9.61 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment China | 12 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 1 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
None listed