Generalized Anxiety DisorderNCT07770919
Continuous Theta Burst Stimulation for Generalized Anxiety Disorder
A study testing Continuous Theta Burst Stimulation of the Right Posterior Parietal Cortex and Continuous Theta Burst Stimulation of the Right Dorsolateral Prefrontal Cortex in people with Generalized Anxiety Disorder, run by Military Hospital 175 at 1 site in Vietnam.
Trial summary
This randomized, rater-blinded clinical trial evaluates the effectiveness, safety, and tolerability of continuous theta burst stimulation (cTBS) in adults with generalized anxiety disorder (GAD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Continuous Theta Burst Stimulation of the Right Posterior Parietal Cortex and Continuous Theta Burst Stimulation of the Right Dorsolateral Prefrontal Cortex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteVietnam
- Study dates
- 9 Sep 2026to Jun 2028
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years.
- Right-handed.
- Diagnosis of generalized anxiety disorder (GAD) according to ICD-10 criteria (F41.1), confirmed by a psychiatrist.
- GAD must be the primary diagnosis and the main reason for treatment at the time of enrollment. Current or past comorbid major depressive disorder will be identified and recorded.
- Hamilton Anxiety Rating Scale (HAM-A) total score >18 at screening/baseline.
- Able and willing to provide written informed consent and comply with essential study procedures.
- Participants may be psychotropic-medication naïve or may be receiving psychotropic medication. Participants currently receiving psychotropic medication must have maintained the same medication(s) and dose(s) for at least 2 weeks before randomization; for fluoxetine, the required stable period is at least 4 weeks.
Who cannot join
- Intracranial or head/neck metallic foreign bodies or implants that constitute a contraindication to TMS or MRI.
- Implanted electronic devices such as a cardiac pacemaker, implantable cardioverter-defibrillator, or deep brain stimulator.
- Untreated or clinically unstable thyroid dysfunction based on abnormal TSH and/or free T4 levels.
- Clinically significant intracranial structural abnormalities that may affect TMS safety, neuropsychiatric presentation, or study neurophysiological measures.
- History of epilepsy or seizures, except febrile seizures in childhood.
- Bipolar disorder.
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- Other major psychiatric disorders, including schizophrenia, delusional disorder, or eating disorders.
- Acute suicide risk, including clear suicidal ideation or behavior.
- Alcohol or substance abuse or dependence within the previous 6 months.
- A medical condition associated with a high seizure risk or a history of cranial surgery.
- Current use of medication judged by the screening physician to substantially increase seizure risk, or rapid reduction/discontinuation of benzodiazepines, antiseizure medications, or other centrally acting medications associated with withdrawal or increased seizure risk.
- Serum vitamin D level <20 ng/mL that has not been adequately corrected.
- Elevated C-reactive protein associated with clinically significant acute infection or acute inflammatory illness that, in the investigator's judgment, may affect participant safety or study outcome assessment.
- Pregnant or breastfeeding.
- Unable to understand or complete essential study procedures. Participants with potentially reversible temporary exclusion conditions may be rescreened once the condition has been adequately corrected or clinically stabilized.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Military Hospital 175
Ho Chi Minh City, 70000
Dang Minh Ly, MD, +84359999741, drminhdang09@gmail.com
About this study
Official title: A Randomized Rater-Blinded Trial Comparing Continuous Theta Burst Stimulation Targeting the Right Posterior Parietal Cortex and Right Dorsolateral Prefrontal Cortex for Generalized Anxiety Disorder
This randomized, rater-blinded clinical trial evaluates the effectiveness, safety, and tolerability of continuous theta burst stimulation (cTBS) in adults with generalized anxiety disorder (GAD). Participants will be randomly assigned in a 1:1 ratio to receive cTBS targeting either the right posterior parietal cortex (R-PPC) or the right dorsolateral prefrontal cortex (R-DLPFC). Participants may be psychotropic-medication naïve or may continue stable psychotropic medication according to the protocol-defined medication stability criteria.
The primary objective is to compare changes in anxiety symptom severity, measured using the Hamilton Anxiety Rating Scale (HAM-A), from baseline to the end-of-treatment assessment. Secondary and exploratory assessments include treatment response and remission, quality of life, sleep quality, cognitive function, safety and tolerability, resting electroencephalography (EEG), and transcranial magnetic stimulation combined with EEG (TMS-EEG).
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Continuous Theta Burst Stimulation of the Right Posterior Parietal Cortex, Continuous Theta Burst Stimulation of the Right Dorsolateral Prefrontal Cortex
- Keywords
- Generalized Anxiety Disorder, Continuous Theta Burst Stimulation, cTBS, Transcranial Magnetic Stimulation, Posterior Parietal Cortex, Dorsolateral Prefrontal Cortex
- 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.
Continuous Theta Burst Stimulation of the Right Posterior Parietal CortexDevice
Continuous theta burst stimulation (cTBS) is delivered to the right posterior parietal cortex (R-PPC), identified at the P4 location of the international 10-20 EEG system. Each session consists of 600 pulses delivered at 80% of the resting motor threshold (RMT). Participants receive two sessions per treatment day, separated by 30 ± 5-minute intervals, for a total of 10 sessions over approximately 1 week.
Continuous Theta Burst Stimulation of the Right Dorsolateral Prefrontal CortexDevice
Continuous theta burst stimulation (cTBS) is delivered to the right dorsolateral prefrontal cortex (R-DLPFC), identified using the Beam F4 approach. Each session consists of 600 pulses delivered at 100% of the resting motor threshold (RMT). Participants receive one session per treatment day, 5 days per week for 4 weeks, for a total of 20 sessions.
| Study group | Role | What they receive |
|---|---|---|
| cTBS Right Posterior Parietal Cortex | Experimental | Participants receive continuous theta burst stimulation (cTBS) targeting the right posterior parietal cortex (R-PPC). Treatment is delivered at 80% of the resting motor threshold (RMT), with 600 pulses per session. Participants receive two sessions per treatment day, separated by 30 ± 5-minute intervals, for a total of 10 sessions over approximately 1 week. Participants may be psychotropic-medication naïve or may continue stable psychotropic medication according to the protocol-defined medication stability criteria. Receives: Device: Continuous Theta Burst Stimulation of the Right Posterior Parietal Cortex |
| cTBS Right Dorsolateral Prefrontal Cortex | Experimental | Participants receive continuous theta burst stimulation (cTBS) targeting the right dorsolateral prefrontal cortex (R-DLPFC). Treatment is delivered at 100% of the resting motor threshold (RMT), with 600 pulses per session. Participants receive one session per treatment day, 5 days per week for 4 weeks, for a total of 20 sessions. Participants may be psychotropic-medication naïve or may continue stable psychotropic medication according to the protocol-defined medication stability criteria. Receives: Device: Continuous Theta Burst Stimulation of the Right Dorsolateral Prefrontal Cortex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score
The Hamilton Anxiety Rating Scale (HAM-A) is used to assess the severity of anxiety symptoms. The scale consists of 14 items, each rated from 0 to 4, yielding a total score ranging from 0 to 56, with higher scores indicating greater anxiety severity. The primary outcome is the change in HAM-A total score from baseline (T0) to the end-of-treatment assessment (T4).
Measured: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Secondary outcomes (5)
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) Scores
Quality of life is assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), which evaluates four domains: physical health, psychological health, social relationships, and environment. Each domain score is transformed to a 0-100 scale, with higher scores indicating better quality of life. Change in each domain score from baseline to the end-of-treatment assessment will be evaluated.
Measured: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score
The Pittsburgh Sleep Quality Index (PSQI) is used to assess subjective sleep quality over the previous month. It comprises seven component scores that are summed to produce a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. The outcome is the change in PSQI global score from baseline (T0) to the end-of-treatment assessment (T4).
Measured: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Change in Montreal Cognitive Assessment (MoCA) Total Score
The Montreal Cognitive Assessment (MoCA) is used to assess global cognitive function across multiple cognitive domains. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. The outcome is the change in MoCA total score from baseline (T0) to the end-of-treatment assessment (T4).
Measured: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Change in Mini-Mental State Examination (MMSE) Total Score
The Mini-Mental State Examination (MMSE) is used to assess global cognitive function. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. The outcome is the change in MMSE total score from baseline (T0) to the end-of-treatment assessment (T4).
Measured: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Incidence of Adverse Events and Serious Adverse Events
Safety and tolerability will be assessed by monitoring adverse events (AEs) and serious adverse events (SAEs) throughout the treatment period. Adverse events potentially associated with iTBS, including headache, scalp discomfort, dizziness, and other reported adverse events, will be recorded. The number and proportion of participants experiencing at least one AE or SAE will be summarized by treatment group.
Measured: From the first treatment session through the end-of-treatment assessment (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start9 Sep 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Participants with generalized anxiety disorder are randomly assigned in a 1:1 ratio to one of two parallel active-treatment groups receiving continuous theta burst stimulation (cTBS) targeting either the right posterior parietal cortex (R-PPC) or the right dorsolateral prefrontal cortex (R-DLPFC).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Hospital 175
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoang Tien Trong Nghia, Military Hospital 175
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770919
- Sponsor's protocol ID
- KCB-TT.15-GAD
- Status last verified
- Sep 2026
- First submitted
- 13 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Rater-Blinded Trial Comparing Continuous Theta Burst Stimulation Targeting the Right Posterior Parietal Cortex and Right Dorsolateral Prefrontal Cortex for Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT07770919
- Acronym / sponsor ID
- KCB-TT.15-GAD
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized Anxiety Disorder, Continuous Theta Burst Stimulation, cTBS, Transcranial Magnetic Stimulation, Posterior Parietal Cortex, Dorsolateral Prefrontal Cortex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Military Hospital 175University, hospital or other
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 18 Aug 2026 (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.
This randomized, rater-blinded clinical trial evaluates the effectiveness, safety, and tolerability of continuous theta burst stimulation (cTBS) in adults with generalized anxiety disorder (GAD). Participants will be randomly assigned in a 1:1 ratio to receive cTBS targeting either the right posterior parietal cortex (R-PPC) or the right dorsolateral prefrontal cortex (R-DLPFC). Participants may be psychotropic-medication naïve or may continue stable psychotropic medication according to the protocol-defined medication stability criteria.
The primary objective is to compare changes in anxiety symptom severity, measured using the Hamilton Anxiety Rating Scale (HAM-A), from baseline to the end-of-treatment assessment. Secondary and exploratory assessments include treatment response and remission, quality of life, sleep quality, cognitive function, safety and tolerability, resting electroencephalography (EEG), and transcranial magnetic stimulation combined with EEG (TMS-EEG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants with generalized anxiety disorder are randomly assigned in a 1:1 ratio to one of two parallel active-treatment groups receiving continuous theta burst stimulation (cTBS) targeting either the right posterior parietal cortex (R-PPC) or the right dorsolateral prefrontal cortex (R-DLPFC).
| Arm | Type | Receives |
|---|---|---|
| cTBS Right Posterior Parietal Cortex | Experimental | Device: Continuous Theta Burst Stimulation of the Right Posterior Parietal CortexParticipants receive continuous theta burst stimulation (cTBS) targeting the right posterior parietal cortex (R-PPC). Treatment is delivered at 80% of the resting motor threshold (RMT), with 600 pulses per session. Participants receive two sessions per treatment day, separated by 30 ± 5-minute intervals, for a total of 10 sessions over approximately 1 week. Participants may be psychotropic-medication naïve or may continue stable psychotropic medication according to the protocol-defined medication stability criteria. |
| cTBS Right Dorsolateral Prefrontal Cortex | Experimental | Device: Continuous Theta Burst Stimulation of the Right Dorsolateral Prefrontal CortexParticipants receive continuous theta burst stimulation (cTBS) targeting the right dorsolateral prefrontal cortex (R-DLPFC). Treatment is delivered at 100% of the resting motor threshold (RMT), with 600 pulses per session. Participants receive one session per treatment day, 5 days per week for 4 weeks, for a total of 20 sessions. Participants may be psychotropic-medication naïve or may continue stable psychotropic medication according to the protocol-defined medication stability criteria. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 65 years.
- Right-handed.
- Diagnosis of generalized anxiety disorder (GAD) according to ICD-10 criteria (F41.1), confirmed by a psychiatrist.
- GAD must be the primary diagnosis and the main reason for treatment at the time of enrollment. Current or past comorbid major depressive disorder will be identified and recorded.
- Hamilton Anxiety Rating Scale (HAM-A) total score >18 at screening/baseline.
Key exclusion criteria (15 listed)
- Intracranial or head/neck metallic foreign bodies or implants that constitute a contraindication to TMS or MRI.
- Implanted electronic devices such as a cardiac pacemaker, implantable cardioverter-defibrillator, or deep brain stimulator.
- Untreated or clinically unstable thyroid dysfunction based on abnormal TSH and/or free T4 levels.
- Clinically significant intracranial structural abnormalities that may affect TMS safety, neuropsychiatric presentation, or study neurophysiological measures.
- History of epilepsy or seizures, except febrile seizures in childhood.
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 |
|---|---|---|
| Continuous Theta Burst Stimulation of the Right Posterior Parietal CortexContinuous theta burst stimulation (cTBS) is delivered to the right posterior parietal cortex (R-PPC), identified at the P4 location of the international 10-20 EEG system. Each session consists of 600 pulses delivered at 80% of the resting motor threshold (RMT). Participants receive two sessions per treatment day, separated by 30 ± 5-minute intervals, for a total of 10 sessions over approximately 1 week. | Device | cTBS Right Posterior Parietal Cortex |
| Continuous Theta Burst Stimulation of the Right Dorsolateral Prefrontal CortexContinuous theta burst stimulation (cTBS) is delivered to the right dorsolateral prefrontal cortex (R-DLPFC), identified using the Beam F4 approach. Each session consists of 600 pulses delivered at 100% of the resting motor threshold (RMT). Participants receive one session per treatment day, 5 days per week for 4 weeks, for a total of 20 sessions. | Device | cTBS Right Dorsolateral Prefrontal Cortex |
Primary outcome
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
The Hamilton Anxiety Rating Scale (HAM-A) is used to assess the severity of anxiety symptoms. The scale consists of 14 items, each rated from 0 to 4, yielding a total score ranging from 0 to 56, with higher scores indicating greater anxiety severity. The primary outcome is the change in HAM-A total score from baseline (T0) to the end-of-treatment assessment (T4).
5 secondary outcomes
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) Scores
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Change in Montreal Cognitive Assessment (MoCA) Total Score
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Change in Mini-Mental State Examination (MMSE) Total Score
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Incidence of Adverse Events and Serious Adverse Events
Time frame: From the first treatment session through the end-of-treatment assessment (T4)
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 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Theta Burst Stimulation of the Right Posterior Parietal Cortex and Continuous Theta Burst Stimulation of the Right Dorsolateral Prefrontal Cortex in people with Generalized Anxiety Disorder, run by Military Hospital 175 at 1 site in Vietnam.
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 7 inclusion and 15 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 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 Vietnam. 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?
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 Dang Minh Ly, MD (+84359999741, drminhdang@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score (time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)). 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 10 Sep 2026.