An interventional study of Continuous Theta Burst Stimulation of the Right Posterior Parietal Cortex and Continuous Theta Burst Stimulation of the Right Dorsolateral Prefrontal Cortex in Generalized Anxiety Disorder, sponsored by Military Hospital 175. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Military Hospital 175 · Not applicable, Interventional, and Treatment
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).
517 studies on the registry are indexed under Generalized Anxiety Disorder; 124 are open to participants now.
This study's planned enrollment of 40 is below the median of 83 across 439 interventional studies indexed under Generalized Anxiety Disorder.
Browse Generalized Anxiety Disorder studies →Military Hospital 175 is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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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.
Device: Continuous Theta Burst Stimulation of the Right Posterior Parietal Cortex
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.
Device: Continuous Theta Burst Stimulation of the Right Dorsolateral Prefrontal Cortex
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 (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.
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).
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: From the first treatment session through the end-of-treatment assessment (T4)
Change in Individual Alpha Frequency (IAF)
Individual alpha frequency (IAF) will be derived from resting-state electroencephalography (EEG). Change in IAF from baseline to the post-treatment neurophysiological assessment will be evaluated as an exploratory neurophysiological outcome.
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Change in TMS-Evoked N45 Amplitude
Transcranial magnetic stimulation-electroencephalography (TMS-EEG) will be used to measure the N45 component of the TMS-evoked potential. Change in N45 amplitude from baseline (T0) to the end-of-treatment assessment (T4) will be evaluated as an exploratory neurophysiological outcome.
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Change in TMS-Evoked P60 Amplitude
Transcranial magnetic stimulation-electroencephalography (TMS-EEG) will be used to measure the P60 component of the TMS-evoked potential. Change in P60 amplitude from baseline (T0) to the end-of-treatment assessment (T4) will be evaluated as an exploratory neurophysiological outcome.
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Change in TMS-Evoked N100 Amplitude
Transcranial magnetic stimulation-electroencephalography (TMS-EEG) will be used to measure the N100 component of the TMS-evoked potential. Change in N100 amplitude from baseline (T0) to the end-of-treatment assessment (T4) will be evaluated as an exploratory neurophysiological outcome.
Time frame: Baseline (T0) and 24-72 hours after the final treatment session (T4)
Plan to share: Undecided
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Started Sep 2026 (actual). Primary completion is estimated for Jun 2028, 21 months after the start.
Of 174 non-industry interventional studies with no phase under Generalized Anxiety Disorder, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 55. This study's planned 21 months is below that.
Counting every sponsor, half of 183 studies reached it within 28 months; a quarter within 15 and three quarters within 53.
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Generalized Anxiety Disorder →