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Recruiting NCT07111169

Neuromodulation and Attention Deficits in MDD

No phase Interventional Major Depression Disorder Cognitive Deficits Selective Attention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: intermittent theta burst stimulation (iTBS) intervention.
Who it may be relevant to
Registry conditions: Major Depression Disorder, Cognitive Deficits, Selective Attention. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Device intermittent theta burst stimulation (iTBS) intervention
    iTBS protocol: Intervention with an 80-120% resting threshold was used. In the active group, the left dlPFC was selected as the stimulation site and a stimulation protocol with iTBS parameters was given. This was a neuro-modulation protocol of excitatory sequences, with theta burst stimulation at 50 Hz, repeated at 5 Hz, stimulation for 2 s with an interval of 8 s, for a total of 1,800 pulses, with a treatment time of about 20 min/session, two sessions per day, with a15-30 min rest between sessi

Primary outcome measures

  • Depression severity following two weeks of iTBS treatment. [Time frame: 60-90 minutes before the first iTBS treatment and 60-90 minutes after last iTBS treatment.]
Secondary outcome measures (3)
  • Intervention-related ERPs changes in the additional singleton task after 2 weeks of active/sham iTBS treatment. [Time frame: 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. [Time frame: 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. [Time frame: 30-60 minutes before the first iTBS treatment and 30-60 minutes after the last iTBS treatment.]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The Clinical Hospital of Chengdu Brain Science Institute, Chengdu Fourth People's Hospital — Chengdu

Identifiers

NCT: NCT07111169 · BAM_lab_MDD_01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗