RecruitingRecruiting
Neuromodulation and Attention Deficits in MDD
NCT07111169 · University of Electronic Science and Technology of China
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Selective Attention Deficits and Neuromodulation in Major Depressive Disorder: Using EEG and MRI-guided iTBS Study
About this study
Major Depressive Disorder (MDD) is associated with impaired selective attention and disrupted top-down control, yet the underlying neurophysiological mechanisms remain poorly understood. The present double-blind, sham-controlled trial will test whether iTBS over the left DLPFC, an FDA-approved rTMS site, can restore top-down distractor suppression in MDD (active-iTBS: n = 30; sham-iTBS: n = 30). Neuronavigated iTBS will be delivered across sessions, and effects will be assessed on the behavioral level (additional singleton paradigm) and the neurophysiological level (using concomitant EEG). Key aim of the project is to compare neuronavigated (active-iTBS) versus manual (Beam F3 method, sham-iTBS group) localization of the stimulation site.
Eligibility criteria
Inclusion Criteria:
* 18-55 years
* Right-handed
* Normal or corrected normal visual acuity
* MDD: meet the proposed DSM-5 MDD criteria, unmedicated or stable medicated within the last one month. Healthy subjects without any past or present psychiatric or neurological disorders.
Exclusion Criteria:
* Diagnosis of other severe mental disorders, such as schizophrenia, bipolar disorder, neurodevelopmental disorder, etc.
* high suicidal risk
* Unnormal intellectual functioning, auditory impairments,
* Have received neuromodulation, such as Modified Electroconvulsive Therapy (MECT), or any psychotherapy within the past 6 months.
* Only for the active-iTBS group: have a contraindication to MRI scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for MRI scanning).
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: triple
Age groups: adult
Timeline
Starts: 2024-01-01
Estimated completion: 2028-12-30
Last updated: 2025-08-08
Interventions
Device: intermittent theta burst stimulation (iTBS) intervention
Primary outcomes
- • Depression severity following two weeks of iTBS treatment. (60-90 minutes before the first iTBS treatment and 60-90 minutes after last iTBS treatment.)
Sponsor
University of Electronic Science and Technology of China · other
All locations (1)
The Clinical Hospital of Chengdu Brain Science Institute, Chengdu Fourth People's Hospital, Jiujiang Branch (Chengdu Mental Health Center)Recruiting
Chengdu, Sichuan, China