Context-Guided Personalized iTBS for Depression
3 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Zhi Yang, PhD
- Numéro de téléphone: +86 186 1171 0840
- E-mail: yangz@mail.ccmu.edu.cn
Lieux d'étude
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100088
- Beijing Anding Hospital, Capital Medical University
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Contact:
- Zhi Yang, PhD
- Numéro de téléphone: +8618611710840
- E-mail: yangz@mail.ccmu.edu.cn
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
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Comparateur actif: 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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Treatment Response Rate at 2-Week Follow-up Based on HAMD-17
Délai: At 2 weeks after completion of treatment (Day 21 ± 2 days).
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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.
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At 2 weeks after completion of treatment (Day 21 ± 2 days).
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of Adverse Events
Délai: From the first treatment session through the 2-week follow-up after completion of treatment
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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.
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From the first treatment session through the 2-week follow-up after completion of treatment
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Early Treatment Response Rate Based on HAMD-17
Délai: Baseline to immediately after completion of the treatment intervention
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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.
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Baseline to immediately after completion of the treatment intervention
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Change From Baseline in HAMD-17 Factor Scores
Délai: Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
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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.
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Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
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Change From Baseline in QIDS-SR16 Total Score
Délai: Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
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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.
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Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
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Change From Baseline in HAMA Total Score
Délai: Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
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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.
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Baseline, immediately after completion of treatment, and 2 weeks after completion of treatment
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Zhi Yang, PhD, Beijing Anding Hospital, Capital Medical University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
30 octobre 2027
Achèvement de l'étude (Estimé)
30 octobre 2027
Dates d'inscription aux études
Première soumission
29 juillet 2026
Première soumission répondant aux critères de contrôle qualité
29 juillet 2026
Première publication (Réel)
3 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BRWEP2024W072120106
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .