跳至主要内容
临床试验/NCT07111169
NCT07111169招募中不适用

Selective Attention Deficits and Neuromodulation in Major Depressive Disorder: Using EEG and MRI-guided iTBS Study

University of Electronic Science and Technology of China1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Depression severity following two weeks of iTBS treatment.

研究概览

简要总结

Multimodal study (Behavior, TMS, EEG) combining a sham-controlled intermittent theta burst stimulation (iTBS) intervention with an additional-singleton task and EEG to evaluate whether left dorsolateral prefrontal cortex (DLPFC) stimulation enhances cognitive control and modulates maladaptive attention processes in MDD and whether the effects are influenced by neuronavigated versus manual (Beam F3 method) localization of the stimulation site.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participants did not know whether they were receiving iTBS or sham; Intervention Operator knew whether the participants were receiving iTBS or sham; and Outcomes Assessor who evaluated HAMD/HAMA and analyzed the scale data did not know which group each MDD participant was assigned to.

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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).

研究组 & 干预措施

MDD subjects in the active group undergo 10 days of MRI-guided iTBS intervention

Experimental

Neuronavigation procedure: During the iTBS treatment, the high-resolution T1-weighted scans of each subject will be uploaded to the BrainSight neuronavigation system (version 2.4.11), adjusted, and remodelled into a three-dimensional model. Then, the neuronavigation system is calibrated and validated on the subject. Next, we localized each participant's left-lateral dlPFC stimulation target using Talairach coordinates (-45, 45, 35). The head position is standardized using the nasal tip, sinuses, and bilateral ear screens as baseline markers, and the location of the target on the scalp is identified in each participant's natural space anatomical image. In the end, we observe on the computer screen whether the coil position is placed above the target through the navigation software and artificially control the coil to be tangent to the skull, with the center of the figure-of-eight coil always directly above the target.

干预措施: intermittent theta burst stimulation (iTBS) intervention (Device)

MDD controls in the sham-iTBS group receive the same intervention but Beam F3 site.

Sham Comparator

Target Localization and Cap Placement Procedure: The stimulation target was the EEG 10-20 coordinate F3, corresponding to the probabilistic location of the left dorsolateral prefrontal cortex (DLPFC). We localized this site using the Beam F3 method and a TMS elastic cap (patent no. 201120150878.5, Wuhan YIRUIDE Medical Equipment Co., Ltd.), and verified it with the F3 electrode on the standard EEG cap. Before the first session, the elastic cap was aligned using anatomical landmarks (nasion, inion, and ears), and the F3 position was marked for consistent coil placement. This standardized approach ensured precise and repeatable targeting across TMS sessions.

干预措施: intermittent theta burst stimulation (iTBS) intervention (Device)

结局指标

主要结局

Depression severity following two weeks of iTBS treatment.

时间窗: 60-90 minutes before the first iTBS treatment and 60-90 minutes after last iTBS treatment.

Depression severity will be assessed, using 24-item Hamilton Depression Scale (HAMD-24) before and after the iTBS intervention. Changes will be computed as (pre-treatment score - post-treatment score)/pre-treatment score × 100%). We hypothesize that the neuronaviogated group has a better treatment effect indexed by the mean HAMD subtraction rate than the sham-control group.

次要结局

  • Intervention-related ERPs changes in the additional singleton task after 2 weeks of active/sham iTBS treatment.(30-60 minutes before the first iTBS treatment and 30-60 minutes after last iTBS treatment.)
  • Intervention-related brain connectivity after 2 weeks of active/sham iTBS treatment.(30-60 minutes before the first iTBS treatment and 30-60 minutes after last iTBS treatment.)
  • Intervention-related behavior changes in the additional singleton task after 2 weeks of active/sham iTBS treatment.(30-60 minutes before the first iTBS treatment and 30-60 minutes after the last iTBS treatment.)

研究者

发起方
University of Electronic Science and Technology of China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Benjamin Becker

Beckerlab

University of Electronic Science and Technology of China

研究点 (1)

Loading locations...

相似试验