Context-Guided Personalized iTBS for Depression

Summary

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.

Conditions

• Major Depressive Disorder (MDD)

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• Capital Medical University

  lead OTHER

Principal Investigators

• Zhi Yang, PhD · Beijing Anding Hospital, Capital Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2027-10-30

Completion

2027-10-30

Countries

• China

Study Locations