Generalized Anxiety DisorderNAVI-GADNCT07121712
Navigated cTBS for the Treatment of Generalized Anxiety Disorder
A study testing Mapsd Continuous Theta Burst Stimulation in people with Generalized Anxiety Disorder, run by WANG KAI at 2 sites in China.
Trial summary
The purpose of this study is to investigate the effectiveness of a non-invasive brain stimulation technique called continuous Theta Burst Stimulation (cTBS) for treating Generalized Anxiety Disorder (GAD). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Mapsd Continuous Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 9 Sep 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), confirmed by at least two psychiatrists.
- Hamilton Anxiety Rating Scale (HAMA) score > 14.
- Age between 18 and 60 years.
- More than 5 years of education.
- Right-handed.
- Normal or corrected-to-normal visual acuity.
- Able to cooperate with the completion of all experimental procedures.
- Willing and able to provide written informed consent.
Who cannot join
- Presence of other psychiatric disorders, such as substance abuse, schizophrenia, schizoaffective disorder, hysteria, or autism.
- Presence of severe neurological diseases (e.g., stroke), or any personal or family history of epilepsy or seizures.
- Presence of severe somatic diseases, such as severe heart, liver, or renal insufficiency.
- Pregnant or lactating women.
- Contraindications to Transcranial Magnetic Stimulation (TMS) or Magnetic Resonance Imaging (MRI), such as the presence of a cardiac pacemaker, cochlear implant, cerebrovascular metal stent, or metal dentures.
- Inability to cooperate with experimental procedures due to conditions such as depressive stupor or severe claustrophobia.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tongjian Bai, MD contact
China2 sites, 2 recruiting
- Recruiting
Anhui Medical University
Hefei, Anhui, 230000
Kai Wang, MD, +86-0551-62923704, wangkai1964@126.com
- Recruiting
Anhui Medical University
Hefei, Anhui, 230000
Kai Professor, MD, +86-0551-62923704, wangkai1964@126.com
About this study
Official title: Efficacy and Neural Mechanisms of Navigated Continuous Theta Burst Stimulation (cTBS) for Generalized Anxiety Disorder (GAD)
The purpose of this study is to investigate the effectiveness of a non-invasive brain stimulation technique called continuous Theta Burst Stimulation (cTBS) for treating Generalized Anxiety Disorder (GAD). The researchers will use a neuronavigation system, which acts like a GPS for the brain based on a participant's own MRI scan, to guide the stimulation to a specific target in the brain's auditory association cortex. This area is involved in processing information and may play a role in anxiety.
Participants who enroll will be randomly assigned to one of two groups. One group will receive active cTBS treatment, while the other will receive a sham (placebo) stimulation that feels similar but has no therapeutic effect. The treatment will be given three times a day for seven consecutive days.
Before and after the treatment period, all participants will complete clinical questionnaires to measure their anxiety and related symptoms. They will also undergo Magnetic Resonance Imaging (MRI) scans to help researchers understand how cTBS affects brain activity. A follow-up assessment will be conducted two weeks after the treatment ends to check on symptoms.
Read the detailed description
This study is a randomized, triple-blind, sham-controlled trial designed to evaluate the efficacy and neural mechanisms of neuronavigation-guided continuous Theta Burst Stimulation (cTBS) in patients with Generalized Anxiety Disorder (GAD).
A total of 40 patients diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) will be recruited from the First and Second Affiliated Hospitals of Anhui Medical University. After providing informed consent, participants will be randomized in a 1:1 ratio to receive either active cTBS or sham cTBS.
The stimulation target is the left auditory association cortex (posterior superior temporal sulcus), with coordinates derived from previous literature (Neri et al., 2024; MNI coordinates: -62, -40, 10). The TMStarget software will be used to transform these coordinates into each participant's native brain space, and a Brainsight neuronavigation system will guide coil placement for precise targeting.
The active intervention will be delivered using a MagStim Rapid2 stimulator with a 70mm air-cooled figure-of-eight coil. Stimulation intensity will be set at 100% of the individual's resting motor threshold (RMT). The cTBS protocol consists of 3-pulse bursts at 50 Hz, repeated at a 5 Hz frequency, for a total of 600 pulses per session (duration of approximately 41 seconds). The sham intervention will utilize an identical-looking sham coil that produces similar sounds without inducing a significant magnetic field, ensuring the integrity of the blinding.
The treatment schedule consists of three sessions per day, with a 15-minute interval between sessions, for seven consecutive days (from Day 2 to Day 8 of the study protocol).
All participants will undergo comprehensive assessments at baseline (Day 1) and immediately after the final treatment session (Day 9). Assessments include a battery of clinical scales and multimodal magnetic resonance imaging (MRI). The MRI protocol includes high-resolution structural (3D-T1), resting-state functional MRI (rs-fMRI), Diffusion Tensor Imaging (DTI), and specific sequences targeting the Locus Coeruleus. A follow-up assessment of clinical symptoms will be conducted two weeks after the end of the intervention.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Mapsd Continuous Theta Burst Stimulation, Sham Navigated Continuous Theta Burst Stimulation
- Keywords
- Generalized Anxiety Disorder, Continuous Theta Burst Stimulation, Transcranial Magnetic Stimulation, Neuronavigation, Magnetic Resonance Imaging
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mapsd Continuous Theta Burst StimulationDevice
A non-invasive brain stimulation technique using a MagStim Rapid2 stimulator with a 70mm air-cooled figure-of-eight coil. The stimulation target is the left auditory association cortex (MNI: -62, -40, 10), located using a Brainsight neuronavigation system. The cTBS protocol consists of 3-pulse 50 Hz bursts repeated at a 5 Hz frequency for a total of 600 pulses, delivered at 100% of the individual's resting motor threshold (RMT).
Sham Navigated Continuous Theta Burst StimulationDevice
A placebo procedure using an inert sham coil that is identical in appearance and sound to the active coil but does not deliver a significant magnetic field to the cortex. All other aspects of the procedure, including neuronavigation, coil placement, duration, and sound, are identical to the active intervention to maintain the blind.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Navigated cTBS | Experimental | Participants will receive active continuous Theta Burst Stimulation (cTBS) guided by a neuronavigation system to the left auditory association cortex. Treatment will be administered three times a day for seven consecutive days. Receives: Device: Mapsd Continuous Theta Burst Stimulation |
| Sham Comparator: Sham cTBS | Sham comparator | Participants will undergo a sham cTBS procedure using a placebo coil that mimics the sound and sensation of the active stimulation but delivers no effective magnetic field. The procedure, including targeting and duration, is identical to the active group to maintain blinding. Receives: Device: Sham Navigated Continuous Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Hamilton Anxiety Rating Scale (HAMA) Score
The HAMA is a 14-item, clinician-administered scale used to assess the severity of anxiety symptoms. Total scores range from 0 to 56, with higher scores indicating more severe anxiety. The change in total score from baseline to post-intervention will be
Measured: Baseline (Day 1), Post-intervention (Day 9), and a 2-week follow-up.
Change from Baseline in Self-Rating Anxiety Scale (SAS) Score
The SAS is a 20-item self-report scale designed to measure the severity of anxiety symptoms. The standard score ranges from 25 to 100, where higher scores indicate more severe levels of anxiety. The change in standard score from baseline will be assessed.
Measured: Baseline (Day 1), Post-intervention (Day 9), and a 2-week follow-up.
Change from Baseline in Resting-State Neural Activity
Changes in resting-state brain activity will be measured by functional magnetic resonance imaging (fMRI). Analyses will examine neural activity and network dynamics related to the stimulation target (left auditory cortex) and brain circuits implicated in anxiety.
Measured: Baseline (Day 1) and Post-intervention (Day 9).
Secondary outcomes (4)
Change from Baseline in Hamilton Depression Rating Scale (HAMD-17) Score
The HAMD-17 is a 17-item, clinician-rated scale to assess the severity of depression. Total scores range from 0 to 52, with higher scores indicating more severe depression.
Measured: Baseline (Day 1) and Post-intervention (Day 9).
Change from Baseline in Patient Health Questionnaire-15 (PHQ-15) Score
The PHQ-15 is a 15-item self-report scale to assess the severity of somatic symptoms. Total scores range from 0 to 30, with higher scores indicating more severe somatic symptoms.
Measured: Baseline (Day 1) and Post-intervention (Day 9).
Change from Baseline in Four-Dimensional Symptom Questionnaire (4DSQ) Somatization Subscale Score
The 4DSQ Somatization subscale is a 16-item self-report measure to assess distress from physical symptoms. Scores range from 0 to 32, with higher scores reflecting greater distress from somatization.
Measured: Baseline (Day 1) and Post-intervention (Day 9).
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score
The PSQI is a self-report questionnaire assessing sleep quality. The global score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Measured: Baseline (Day 1) and Post-intervention (Day 9).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start9 Sep 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WANG KAI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, WANG KAI, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121712
- Sponsor's protocol ID
- AnHuiMU-GAD-cTBS-2025
- Acronym
- NAVI-GAD
- Status last verified
- Sep 2025
- First submitted
- 29 Jun 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ji GJ, Ren C, Li Y, Sun J, Liu T, Gao Y, Xue D, Shen L, Cheng W, Zhu C, Tian Y, Hu P, Chen X, Wang K. Regional and network properties of white matter function in Parkinson's disease. Hum Brain Mapp. 2019 Mar;40(4):1253-1263. doi: 10.1002/hbm.24444. Epub 2018 Nov 10.
PubMed 30414340Neri F, Cappello C, Viberti F, Donniacuo A, Burzi L, Cinti A, Benelli A, Luca Smeralda C, Romanella S, Santarnecchi E, Mandala M, Rossi S. rTMS of the auditory association cortex improves speech intelligibility in patients with sensorineural hearing loss. Clin Neurophysiol. 2024 Apr;160:38-46. doi: 10.1016/j.clinph.2024.02.007. Epub 2024 Feb 9.
PubMed 38395005
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Neural Mechanisms of Navigated Continuous Theta Burst Stimulation (cTBS) for Generalized Anxiety Disorder (GAD)
- ClinicalTrials.gov ID
- NCT07121712
- Acronym / sponsor ID
- NAVI-GAD / AnHuiMU-GAD-cTBS-2025
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized Anxiety Disorder, Continuous Theta Burst Stimulation, Transcranial Magnetic Stimulation, Neuronavigation, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- WANG KAIUniversity, hospital or other
- Study start
- 9 Sep 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effectiveness of a non-invasive brain stimulation technique called continuous Theta Burst Stimulation (cTBS) for treating Generalized Anxiety Disorder (GAD). The researchers will use a neuronavigation system, which acts like a GPS for the brain based on a participant's own MRI scan, to guide the stimulation to a specific target in the brain's auditory association cortex. This area is involved in processing information and may play a role in anxiety.
Participants who enroll will be randomly assigned to one of two groups. One group will receive active cTBS treatment, while the other will receive a sham (placebo) stimulation that feels similar but has no therapeutic effect. The treatment will be given three times a day for seven consecutive days.
Before and after the treatment period, all participants will complete clinical questionnaires to measure their anxiety and related symptoms. They will also undergo Magnetic Resonance Imaging (MRI) scans to help researchers understand how cTBS affects brain activity. A follow-up assessment will be conducted two weeks after the treatment ends to check on symptoms.
Detailed description
This study is a randomized, triple-blind, sham-controlled trial designed to evaluate the efficacy and neural mechanisms of neuronavigation-guided continuous Theta Burst Stimulation (cTBS) in patients with Generalized Anxiety Disorder (GAD).
A total of 40 patients diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) will be recruited from the First and Second Affiliated Hospitals of Anhui Medical University. After providing informed consent, participants will be randomized in a 1:1 ratio to receive either active cTBS or sham cTBS.
The stimulation target is the left auditory association cortex (posterior superior temporal sulcus), with coordinates derived from previous literature (Neri et al., 2024; MNI coordinates: -62, -40, 10). The TMStarget software will be used to transform these coordinates into each participant's native brain space, and a Brainsight neuronavigation system will guide coil placement for precise targeting.
The active intervention will be delivered using a MagStim Rapid2 stimulator with a 70mm air-cooled figure-of-eight coil. Stimulation intensity will be set at 100% of the individual's resting motor threshold (RMT). The cTBS protocol consists of 3-pulse bursts at 50 Hz, repeated at a 5 Hz frequency, for a total of 600 pulses per session (duration of approximately 41 seconds). The sham intervention will utilize an identical-looking sham coil that produces similar sounds without inducing a significant magnetic field, ensuring the integrity of the blinding.
The treatment schedule consists of three sessions per day, with a 15-minute interval between sessions, for seven consecutive days (from Day 2 to Day 8 of the study protocol).
All participants will undergo comprehensive assessments at baseline (Day 1) and immediately after the final treatment session (Day 9). Assessments include a battery of clinical scales and multimodal magnetic resonance imaging (MRI). The MRI protocol includes high-resolution structural (3D-T1), resting-state functional MRI (rs-fMRI), Diffusion Tensor Imaging (DTI), and specific sequences targeting the Locus Coeruleus. A follow-up assessment of clinical symptoms will be conducted two weeks after the end of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Navigated cTBS | Experimental | Device: Mapsd Continuous Theta Burst StimulationParticipants will receive active continuous Theta Burst Stimulation (cTBS) guided by a neuronavigation system to the left auditory association cortex. Treatment will be administered three times a day for seven consecutive days. |
| Sham Comparator: Sham cTBS | Sham comparator | Device: Sham Navigated Continuous Theta Burst StimulationParticipants will undergo a sham cTBS procedure using a placebo coil that mimics the sound and sensation of the active stimulation but delivers no effective magnetic field. The procedure, including targeting and duration, is identical to the active group to maintain blinding. |
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) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), confirmed by at least two psychiatrists.
- Hamilton Anxiety Rating Scale (HAMA) score > 14.
- Age between 18 and 60 years.
- More than 5 years of education.
- Right-handed.
Key exclusion criteria (6 listed)
- Presence of other psychiatric disorders, such as substance abuse, schizophrenia, schizoaffective disorder, hysteria, or autism.
- Presence of severe neurological diseases (e.g., stroke), or any personal or family history of epilepsy or seizures.
- Presence of severe somatic diseases, such as severe heart, liver, or renal insufficiency.
- Pregnant or lactating women.
- Contraindications to Transcranial Magnetic Stimulation (TMS) or Magnetic Resonance Imaging (MRI), such as the presence of a cardiac pacemaker, cochlear implant, cerebrovascular metal stent, or metal dentures.
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 |
|---|---|---|
| Mapsd Continuous Theta Burst StimulationA non-invasive brain stimulation technique using a MagStim Rapid2 stimulator with a 70mm air-cooled figure-of-eight coil. The stimulation target is the left auditory association cortex (MNI: -62, -40, 10), located using a Brainsight neuronavigation system. The cTBS protocol consists of 3-pulse 50 Hz bursts repeated at a 5 Hz frequency for a total of 600 pulses, delivered at 100% of the individual's resting motor threshold (RMT). | Device | Experimental: Navigated cTBS |
| Sham Navigated Continuous Theta Burst StimulationA placebo procedure using an inert sham coil that is identical in appearance and sound to the active coil but does not deliver a significant magnetic field to the cortex. All other aspects of the procedure, including neuronavigation, coil placement, duration, and sound, are identical to the active intervention to maintain the blind. | Device | Sham Comparator: Sham cTBS |
Primary outcome
Change from Baseline in Hamilton Anxiety Rating Scale (HAMA) Score
Time frame: Baseline (Day 1), Post-intervention (Day 9), and a 2-week follow-up.
The HAMA is a 14-item, clinician-administered scale used to assess the severity of anxiety symptoms. Total scores range from 0 to 56, with higher scores indicating more severe anxiety. The change in total score from baseline to post-intervention will be
Change from Baseline in Self-Rating Anxiety Scale (SAS) Score
Time frame: Baseline (Day 1), Post-intervention (Day 9), and a 2-week follow-up.
The SAS is a 20-item self-report scale designed to measure the severity of anxiety symptoms. The standard score ranges from 25 to 100, where higher scores indicate more severe levels of anxiety. The change in standard score from baseline will be assessed.
Change from Baseline in Resting-State Neural Activity
Time frame: Baseline (Day 1) and Post-intervention (Day 9).
Changes in resting-state brain activity will be measured by functional magnetic resonance imaging (fMRI). Analyses will examine neural activity and network dynamics related to the stimulation target (left auditory cortex) and brain circuits implicated in anxiety.
4 secondary outcomes
Change from Baseline in Hamilton Depression Rating Scale (HAMD-17) Score
Time frame: Baseline (Day 1) and Post-intervention (Day 9).
Change from Baseline in Patient Health Questionnaire-15 (PHQ-15) Score
Time frame: Baseline (Day 1) and Post-intervention (Day 9).
Change from Baseline in Four-Dimensional Symptom Questionnaire (4DSQ) Somatization Subscale Score
Time frame: Baseline (Day 1) and Post-intervention (Day 9).
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline (Day 1) and Post-intervention (Day 9).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Background: PubMed 30414340Ji GJ, Ren C, Li Y, Sun J, Liu T, Gao Y, Xue D, Shen L, Cheng W, Zhu C, Tian Y, Hu P, Chen X, Wang K. Regional and network properties of white matter function in Parkinson's disease. Hum Brain Mapp. 2019 Mar;40(4):1253-1263. doi: 10.1002/hbm.24444. Epub 2018 Nov 10.
- Background: PubMed 38395005Neri F, Cappello C, Viberti F, Donniacuo A, Burzi L, Cinti A, Benelli A, Luca Smeralda C, Romanella S, Santarnecchi E, Mandala M, Rossi S. rTMS of the auditory association cortex improves speech intelligibility in patients with sensorineural hearing loss. Clin Neurophysiol. 2024 Apr;160:38-46. doi: 10.1016/j.clinph.2024.02.007. Epub 2024 Feb 9.
- 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.
Tongjian Bai, MD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mapsd Continuous Theta Burst Stimulation in people with Generalized Anxiety Disorder, run by WANG KAI at 2 sites 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 6 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: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Wang, MD (+86-0551-62923704, wangkai1964@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Hamilton Anxiety Rating Scale (HAMA) Score (time frame: Baseline (Day 1), Post-intervention (Day 9), and a 2-week follow-up.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07121712, which also lists 2 linked publications.
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 10 Sep 2025.