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- Ensayo clínico NCT07930000
Phase-Locked Accelerated Intermittent Theta Burst Stimulation for Treatment-Resistant Depression
Development of Precision Medicine in the Field of iTBS on Patients With TRD Using Multimodal Functional Brain Imaging and Deep Learning
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:
- Phase-locked aiTBS (PL-aiTBS): Magnetic stimulation was synchronized with a specific phase of ongoing brain activity measured using electroencephalography (EEG).
- 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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Taipei City
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Taipei, Taipei City, Taiwán, 112
- Cheng Hsin General Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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. |
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. |
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Comparador activo: Random-Phase Accelerated iTBS (RP-aiTBS)
Participants received the same individualized aiTBS protocol without phase-locked synchronization to ongoing frontal theta oscillations. |
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 mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in HAM-D Total Score
Periodo de tiempo: Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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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. |
Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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Change in MADRS Total Score
Periodo de tiempo: Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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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. |
Baseline (Day 1), Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Response Rate Based on HAM-D
Periodo de tiempo: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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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. |
Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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Response Rate Based on MADRS
Periodo de tiempo: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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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. |
Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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Remission Rate Based on HAM-D17
Periodo de tiempo: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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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. |
Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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Remission Rate Based on MADRS
Periodo de tiempo: Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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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. |
Mid-treatment (Day 2), Post-treatment (Day 3), and Follow-up (Day 7)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Resting-State EEG Spectral Power
Periodo de tiempo: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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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. |
Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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Change From Baseline in Resting-State EEG Phase-Amplitude Coupling
Periodo de tiempo: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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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. |
Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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Resting-State EEG Functional Connectivity
Periodo de tiempo: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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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. |
Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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Change From Baseline in Resting-State EEG Microstate Parameters
Periodo de tiempo: Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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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. |
Before and after each of the 10 stimulation sessions over the 3-day treatment period (Days 1-3).
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
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Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- (985)111A-63
- (1126)113A-56 (Otro identificador: Cheng Hsin General Hospital Institutional Review Board)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data will not be shared publicly due to participant confidentiality and privacy considerations. No external IPD sharing is currently planned.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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