Anxiety SymptomsNCT06475040
TMS for Anxiety and Trauma-related Disorders
A study testing transcranial magnetic stimulation in people with Anxiety Symptoms and Anxiety Disorders, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anxiety Symptoms, Anxiety Disorders
- What is being tested?
- transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2024to 13 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- Male or female between 18 and 60 years old.
- Right-handed.
- Can understand and sign an informed consent document.
- Beck Anxiety Inventory (BAI) score of 16 or higher.
- On a stable medication/psychotherapy regimen for at least 6 weeks prior to baseline visit and throughout the duration of the study.
- In good general health, as ascertained by medical history.
- Pharmacological treatment resistance or psychotherapeutic treatment resistance.
Who cannot join
- Substance use disorders, eating disorders, significant suicidal ideation, mental disorder due to a medical or neurocognitive condition, lifetime psychosis, bipolar disorder, developmental disorders.
- History of brain surgery and epilepsy.
- Presence of metallic foreign bodies, such as cardiac pacemakers and stents.
- Any medical condition or medication that increases the risk of seizures.
- Pregnancy.
- Intellectual disability.
- Current severe somatic disease, such as cancer, heart failure, pneumonia, etc.
- Severe claustrophobia that prevents the use of MRI.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Accelerated Intermittent Theta Burst Stimulation to a Novel DLPFC Target for Anxiety and Trauma-related Disorders: a Pilot Study
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.
Read the 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
- Being tested
- transcranial magnetic stimulation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulationDevice
non-invasive form of brain stimulation accelerated intermittent theta burst stimulation (aiTBS)
| Study group | Role | What they receive |
|---|---|---|
| Open-label aiTBS to novel right dmPFC TMS anxiety target | Experimental | Not described Receives: Device: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Inventory (BAI)
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.
Measured: Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment.
Secondary outcomes (3)
BAI Response
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.
Measured: Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment.
Hamilton Anxiety Rating Scale (HAMA)
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.
Measured: Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment.
Sheehan Disability Scale (SDS)
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.
Measured: Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start19 Jun 2024
- Primary completion13 Apr 2025
- Study completion13 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anxiety SymptomsStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Sponsor
- Investigators
- Huiru Cui, Ph.D, Principal investigator, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475040
- Sponsor's protocol ID
- HRCui
- Status last verified
- May 2024
- First submitted
- 20 Jun 2024
- Last updated
- 24 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Intermittent Theta Burst Stimulation to a Novel DLPFC Target for Anxiety and Trauma-related Disorders: a Pilot Study
- ClinicalTrials.gov ID
- NCT06475040
- Acronym / sponsor ID
- HRCui
- Conditions
- Anxiety Symptoms, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 13 Apr 2025 (actual)
- Study completion
- 13 Apr 2025 (actual)
- First posted
- 26 Jun 2024 (actual)
- Results
- Posted 24 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label aiTBS to novel right dmPFC TMS anxiety target | Experimental | Device: transcranial magnetic stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
- Male or female between 18 and 60 years old.
- Right-handed.
- Can understand and sign an informed consent document.
- Beck Anxiety Inventory (BAI) score of 16 or higher.
Key exclusion criteria (8 listed)
- Substance use disorders, eating disorders, significant suicidal ideation, mental disorder due to a medical or neurocognitive condition, lifetime psychosis, bipolar disorder, developmental disorders.
- History of brain surgery and epilepsy.
- Presence of metallic foreign bodies, such as cardiac pacemakers and stents.
- Any medical condition or medication that increases the risk of seizures.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial magnetic stimulationnon-invasive form of brain stimulation accelerated intermittent theta burst stimulation (aiTBS) | Device | Open-label aiTBS to novel right dmPFC TMS anxiety target |
Primary outcome
Beck Anxiety Inventory (BAI)
Time frame: 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.
3 secondary outcomes
BAI Response
Time frame: Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment.
Hamilton Anxiety Rating Scale (HAMA)
Time frame: Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment.
Sheehan Disability Scale (SDS)
Time frame: Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huiru Cui, Ph.D principal investigator
Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation in people with Anxiety Symptoms and Anxiety Disorders, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Anxiety Inventory (BAI) (time frame: Assessed at baseline, immediately post-treatment, 1 week post-treatment, 2 weeks post-treatment, and 1 month post-treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.