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Context-Guided Personalized iTBS for Depression

3 agosto 2026 aggiornato da: Zhi Yang, Capital Medical University

Research on Intelligent Optimization of Neuromodulation for Depression Based on Contextual Neuroimaging

The goal of this randomized clinical trial is to learn whether context-guided personalized intermittent theta burst stimulation (iTBS) works better than standard iTBS for adults with major depressive disorder. iTBS is a noninvasive treatment that uses magnetic pulses to stimulate specific areas of the brain.

Participants will be assigned by chance to one of two treatment groups. The standard treatment group will receive iTBS at a commonly used target in the left dorsolateral prefrontal cortex after watching a neutral video. The personalized treatment group will receive iTBS at an individual brain target selected using magnetic resonance imaging data. Before each treatment session, participants in this group will watch a positive emotional video intended to activate brain functions related to the selected target.

Both groups will receive five iTBS sessions per day for five consecutive treatment days. Participants will continue their stable antidepressant treatment during the study.

The main question is whether context-guided personalized iTBS results in a higher treatment response rate than standard iTBS two weeks after treatment. Treatment response is defined as a reduction of at least 50% from baseline in the 17-item Hamilton Depression Rating Scale score.

Researchers will also compare early changes in depression, anxiety and other clinical symptoms, changes in brain imaging measures, and any side effects. Clinical and brain imaging assessments will be conducted before and after the treatment course, and clinical symptoms will be assessed again two weeks after treatment.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100088
        • Beijing Anding Hospital, Capital Medical University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Male or female outpatients or inpatients aged 18 to 55 years, inclusive.
  • Right-handed.
  • Diagnosis of major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed using the Mini International Neuropsychiatric Interview (MINI). Both first and recurrent depressive episodes are eligible.
  • A 17-item Hamilton Depression Rating Scale (HAMD-17) total score of at least 14 at both screening and baseline.
  • At enrollment, participants may be antidepressant-free or may have received an antidepressant at no less than the minimum effective dose for at least 4 weeks. The antidepressant may be combined with no more than two other medications, and the type and dosage of medications must remain unchanged from enrollment until study completion.
  • At least primary school education and able to understand the study procedures and requirements.
  • Able to undergo magnetic resonance imaging and intermittent theta burst stimulation safely.
  • Voluntarily agrees to participate and provides written informed consent.

Exclusion Criteria:

  • Serious or unstable medical or neurological illness.
  • Pregnancy or breastfeeding.
  • History of seizure, epilepsy, hydrocephalus, or central nervous system tumor.
  • Contraindication to magnetic resonance imaging, including claustrophobia, an electronic or metallic implant, or a non-removable metallic dental prosthesis.
  • Receipt of systematic modified electroconvulsive therapy, transcranial magnetic stimulation, deep brain stimulation, vagus nerve stimulation, or another physical neuromodulation treatment within 3 months before screening.
  • Excessive head motion during MRI scanning (rotation exceeding 3.0° and/or translation exceeding 3 mm)
  • Resting motor threshold remaining at or above 70% of the device maximum stimulator output after repeated testing, when the investigator considers continued treatment to present a safety concern.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Context-Guided Personalized iTBS
Participants assigned to this arm will receive context-guided personalized intermittent theta burst stimulation (iTBS). An individualized stimulation target in the left or right dorsolateral prefrontal cortex will be selected based on the participant's functional magnetic resonance imaging data. Before each iTBS session, participants will watch a positive emotional video intended to engage the brain functions related to the individualized target. Participants will receive five iTBS sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days. Each session will last approximately 10 minutes and deliver 1,800 pulses at 100% of the resting motor threshold.
Dispositivo: Context-Guided Personalized Intermittent Theta Burst Stimulation
An individualized stimulation target in the left or right dorsolateral prefrontal cortex is selected using the participant's functional magnetic resonance imaging data. Before each stimulation session, the participant watches a positive emotional video intended to engage brain functions related to the selected target. Intermittent theta burst stimulation is delivered at 100% of the resting motor threshold. Each session delivers 1,800 pulses over approximately 10 minutes. Participants receive five sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days.
Comparatore attivo: Standard Left DLPFC iTBS
Participants assigned to this arm will receive standard intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex. Before each iTBS session, participants will watch a neutral video. Participants will receive five iTBS sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days. Each session will last approximately 10 minutes and deliver 1,800 pulses at 100% of the resting motor threshold.
Dispositivo: Standard Left DLPFC Intermittent Theta Burst Stimulation
Intermittent theta burst stimulation is delivered to a standard treatment target in the left dorsolateral prefrontal cortex. Before each stimulation session, the participant watches a neutral video. Stimulation is delivered at 100% of the resting motor threshold. Each session delivers 1,800 pulses over approximately 10 minutes. Participants receive five sessions per day, with approximately 50 minutes between sessions, for five consecutive treatment days.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Treatment Response Rate at 2-Week Follow-up Based on HAMD-17
Lasso di tempo: At 2 weeks after completion of treatment (Day 21 ± 2 days).
The treatment response rate is defined as the proportion of participants with a reduction of at least 50% from baseline in the total score of the 17-item Hamilton Depression Rating Scale (HAMD-17) at the 2-week follow-up. The HAMD-17 is a clinician-rated scale used to assess the severity of depressive symptoms, with lower scores indicating fewer depressive symptoms. Treatment response rates will be compared between the context-guided personalized iTBS arm and the standard left DLPFC iTBS arm. The HAMD-17 total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity. Change from baseline is calculated as the post-baseline score minus the baseline score, with negative values indicating improvement.
At 2 weeks after completion of treatment (Day 21 ± 2 days).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Adverse Events
Lasso di tempo: From the first treatment session through the 2-week follow-up after completion of treatment
The number and proportion of participants experiencing one or more adverse events will be recorded for each treatment arm. Adverse events may include headache, scalp discomfort, muscle twitching, transient mood changes, or other adverse events occurring during the treatment and follow-up periods.
From the first treatment session through the 2-week follow-up after completion of treatment
Early Treatment Response Rate Based on HAMD-17
Lasso di tempo: Baseline to immediately after completion of the treatment intervention
Early treatment response is defined as a reduction of at least 20% from baseline in the total score of the 17-item Hamilton Depression Rating Scale (HAMD-17) immediately after completion of the treatment intervention. The outcome will be summarized as the proportion of participants meeting this response criterion in each treatment arm. Lower HAMD-17 scores indicate fewer depressive symptoms. The HAMD-17 total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity. Change from baseline is calculated as the post-baseline score minus the baseline score, with negative values indicating improvement.
Baseline to immediately after completion of the treatment intervention
Change From Baseline in HAMD-17 Factor Scores
Lasso di tempo: Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
Changes from baseline in the prespecified factor scores of the 17-item Hamilton Depression Rating Scale (HAMD-17) will be assessed at the 2-week follow-up. For each factor, the change score will be calculated as the follow-up score minus the baseline score. A greater reduction indicates greater improvement in the corresponding depressive symptom domain. The HAMD-17 consists of 17 items; 9 items are scored from 0 to 4 and 8 items are scored from 0 to 2. The total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity. Change is calculated as the post-baseline score minus the baseline score; negative values indicate improvement.
Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
Change From Baseline in QIDS-SR16 Total Score
Lasso di tempo: Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
Changes from baseline in the total score of the 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16) will be assessed immediately after completion of the treatment intervention and at the 2-week follow-up. Lower scores indicate fewer self-reported depressive symptoms. The QIDS-SR16 total score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity.
Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
Change From Baseline in HAMA Total Score
Lasso di tempo: Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
Changes from baseline in the total score of the Hamilton Anxiety Rating Scale (HAMA) will be assessed immediately after completion of the treatment intervention and at the 2-week follow-up. The HAMA is a clinician-rated measure of anxiety symptom severity, with lower scores indicating fewer anxiety symptoms. The 14-item HAMA total score ranges from 0 to 56, with higher scores indicating greater anxiety symptom severity.
Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Capital Medical University

Investigatori

  • Investigatore principale: Zhi Yang, PhD, Beijing Anding Hospital, Capital Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

30 ottobre 2027

Completamento dello studio (Stimato)

30 ottobre 2027

Date di iscrizione allo studio

Primo inviato

29 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 luglio 2026

Primo Inserito (Effettivo)

3 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BRWEP2024W072120106

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared because the current informed consent and ethics-approved protocol authorize the coded and de-identified clinical and neuroimaging data for use within this study only. Study data will be stored and analyzed on a secure internal institutional server.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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