An interventional study of Phase-Locked Accelerated Intermittent Theta Burst Stimulation and Random-Phase Accelerated Intermittent Theta Burst Stimulation in Treatment Resistant Depression (TRD), sponsored by Cheng-Hsin General Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Cheng-Hsin General Hospital · Not applicable, Interventional, and Treatment
This study aims to investigate whether synchronizing accelerated intermittent theta burst stimulation (aiTBS) with an individual's ongoing brain activity improves treatment outcomes in adults with Treatment-Resistant Depression (TRD).
Participants were randomly assigned to one of two treatment groups:
Both groups received personalized stimulation based on their individual theta frequency. Treatment consisted of 10 sessions over three consecutive days, with three sessions on Day 1, three sessions on Day 2, and four sessions on Day 3 (3-3-4 schedule). Each session delivered 1,800 magnetic pulses, resulting in a total of 18,000 pulses per participant.
The primary objective was to compare changes in depressive symptoms between the two treatment groups. Depression severity was assessed using the 17-item Hamilton Depression Rating Scale (HAM-D) and the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline (before the first stimulation session), mid-treatment (after the sixth session, Day 2), post-treatment (after the tenth session, Day 3), and follow-up (Day7).
Resting-state EEG recordings were collected before and after stimulation sessions to investigate treatment-related changes in neural oscillatory activity, phase-amplitude coupling, functional connectivity, and other neurophysiological measures, as well as their potential associations with improvements in depressive symptoms.
448 studies on the registry are indexed under Depressive Disorder, Treatment-Resistant; 147 are open to participants now.
This study's enrollment of 54 is close to the median of 59 across 372 interventional studies indexed under Depressive Disorder, Treatment-Resistant.
Browse Depressive Disorder, Treatment-Resistant studies →Cheng-Hsin General Hospital is the lead sponsor of 23 studies on the registry; 7 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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received individualized accelerated intermittent theta burst stimulation (aiTBS) synchronized to a specific phase of ongoing frontal theta oscillations measured using EEG.
Device: Phase-Locked Accelerated Intermittent Theta Burst Stimulation
Participants received the same individualized aiTBS protocol without phase-locked synchronization to ongoing frontal theta oscillations.
Device: Random-Phase Accelerated Intermittent Theta Burst Stimulation
Stimulation was delivered to the left dorsolateral prefrontal cortex (DLPFC; F3) using an individualized theta-frequency-based iTBS protocol. Each participant received 10 sessions over three consecutive days (3-3-4 schedule), with 1,800 pulses per session (18,000 pulses total). Stimulation was synchronized to the trough of ongoing frontal theta oscillations using real-time EEG phase estimation.
Participants received the same individualized iTBS protocol targeting the left DLPFC (F3), consisting of 10 sessions over three consecutive days (3-3-4 schedule), with 1,800 pulses per session (18,000 pulses total). Stimulation was delivered without phase-locked synchronization to ongoing frontal theta oscillations.
Change in HAM-D Total Score
Depression severity was assessed using the 17-item Hamilton Depression Rating Scale (HAM-D), with total scores ranging from 0 to 52. Higher scores indicate greater depressive symptom severity. Changes in total scores from baseline were evaluated at each post-baseline assessment.
Time frame: Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
Change in MADRS Total Score
Depression severity was assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), with total scores ranging from 0 to 60. Higher scores indicate greater depressive symptom severity. Changes in total scores from baseline were evaluated at each post-baseline assessment.
Time frame: Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
Response Rate Based on HAM-D
Treatment response was defined as a reduction of at least 50% in HAM-D total score relative to baseline. The response rate was calculated as the percentage of participants meeting this criterion at each assessment time point.
Time frame: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
Response Rate Based on MADRS
Treatment response was defined as a reduction of at least 50% in MADRS total score relative to baseline. The response rate was calculated as the percentage of participants meeting this criterion at each assessment time point.
Time frame: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
Remission Rate Based on HAM-D17
Remission was defined as a HAM-D17 total score of 7 or lower. The remission rate was calculated as the percentage of participants meeting this criterion at each assessment time point.
Time frame: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
Remission Rate Based on MADRS
Remission was defined as a MADRS total score of 10 or lower. The remission rate was calculated as the percentage of participants meeting this criterion at each assessment time point.
Time frame: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
Change From Baseline in Resting-State EEG Spectral Power
Resting-state electroencephalography (EEG) was recorded to assess changes in neural oscillatory activity following accelerated intermittent theta burst stimulation (aiTBS). Spectral power was quantified across conventional frequency bands, including delta, theta, alpha, beta, and gamma. Changes in spectral power from baseline were evaluated across treatment stages.
Time frame: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
Change From Baseline in Resting-State EEG Phase-Amplitude Coupling
Resting-state EEG was analyzed to assess phase-amplitude coupling (PAC), reflecting the relationship between the phase of lower-frequency oscillations and the amplitude of higher-frequency activity. Changes in PAC strength from baseline were evaluated across treatment stages to characterize neurophysiological effects of aiTBS.
Time frame: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
Resting-State EEG Functional Connectivity
Resting-state EEG functional connectivity was assessed using phase-based synchronization measures between brain regions. Changes in functional connectivity from baseline were evaluated across treatment stages to investigate stimulation-related alterations in neural synchronization.
Time frame: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
Change From Baseline in Resting-State EEG Microstate Parameters
Resting-state EEG microstate analysis was used to characterize changes in the temporal dynamics of large-scale brain network activity. Microstate parameters included mean duration (ms), occurrence rate (events/s), time coverage (%), and transition probabilities between microstate classes. Changes in these parameters were evaluated across treatment sessions to investigate stimulation-related alterations in brain network dynamics.
Time frame: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
Plan to share: No — Individual participant data will not be shared publicly due to participant confidentiality and privacy considerations. No external IPD sharing is currently planned.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Depressive Disorder, Treatment-Resistant →
Cheng-Hsin General Hospital