Phase-Locked Accelerated Intermittent Theta Burst Stimulation for Treatment-Resistant Depression
Treatment Resistant Depression (TRD)
De qué trata este estudio
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- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - 70 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 54 Real
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Acerca de la investigación
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:
1. Phase-locked aiTBS (PL-aiTBS): Magnetic stimulation was synchronized with a specific phase of ongoing brain activity measured using electroencephalography (EEG).
2. Random-phase aiTBS (RP-aiTBS): Participants received the same stimulation protocol without synchronization to a specific phase of brain activity.
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.
¿Quién podría participar?
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Inclusion Criteria:
- Adults aged 18 to 70 years.
- Diagnosis of major depressive disorder (MDD).
- Inadequate response to at least two antidepressant trials of adequate dose and duration.
- A 17-item Hamilton Depression Rating Scale (HAM-D) score of 9 or higher.
- A Montgomery-Åsberg Depression Rating Scale (MADRS) score of 16 or higher.
- Willingness to participate in the study and provision of written informed consent.
Exclusion Criteria:
- Other psychiatric disorders or serious medical conditions.
- Psychotic disorders.
- Current illicit drug use or alcohol use disorder.
- Neurological or seizure disorders.
- Contraindications to transcranial magnetic stimulation (TMS), including cardiac pacemakers or metallic implants.
- Pregnancy or postpartum depression.
- Electroconvulsive therapy (ECT) within the previous 12 months.
- Unstable medical illness.
- Inability to comply with study procedures.
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento triple
Phase-Locked Accelerated iTBS (PL-aiTBS)
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
Random-Phase Accelerated iTBS (RP-aiTBS)
Participants received the same individualized aiTBS protocol without phase-locked synchronization to ongoing frontal theta oscillations.
Device: Random-Phase Accelerated Intermittent Theta Burst Stimulation
Phase-Locked Accelerated Intermittent Theta Burst Stimulation DEVICE
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.
Random-Phase Accelerated Intermittent Theta Burst Stimulation DEVICE
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Change in HAM-D Total Score
Plazo: Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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.
Change in MADRS Total Score
Plazo: Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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.
Medidas secundarias
Response Rate Based on HAM-D
Plazo: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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.
Response Rate Based on MADRS
Plazo: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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.
Remission Rate Based on HAM-D17
Plazo: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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.
Remission Rate Based on MADRS
Plazo: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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.
Otras medidas
Change From Baseline in Resting-State EEG Spectral Power
Plazo: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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.
Change From Baseline in Resting-State EEG Phase-Amplitude Coupling
Plazo: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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.
Resting-State EEG Functional Connectivity
Plazo: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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.
Change From Baseline in Resting-State EEG Microstate Parameters
Plazo: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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.
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1 centros
Cheng Hsin General HospitalTaipei, Taipei City, TaiwanEstado desconocido
Equipo y fechas
- Patrocinador principal
- Cheng-Hsin General Hospital
- Inicio del estudio
- 22 may 2024 Real
- Finalización primaria
- 15 abr 2026 Real
- Finalización del estudio
- 15 abr 2026 Real
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Development of Precision Medicine in the Field of iTBS on Patients With TRD Using Multimodal Functional Brain Imaging and Deep Learning
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026