Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
All Genders
ID07111169

Selective Attention Deficits and Neuromodulation in Major Depressive Disorder Using EEG and MRI-guided Intermittent Theta Burst Stimulation Study

Led by University of Electronic Science and Technology of China · Updated on 2025-08-08

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether stimulating the left dorsolateral prefrontal cortex (DLPFC) with intermittent theta burst stimulation (iTBS) can improve cognitive control and reduce attention problems in people with Major Depressive Disorder (MDD). This study compares brain stimulation guided by MRI-based neuronavigation to a manual method called the Beam F3 method to see which better affects attention and brain activity in MDD. The trial is double-blind and sham-controlled, involving behavioral tests and EEG measurements to understand the brain mechanisms involved. Participants are randomly assigned to one of two groups: the active group receives MRI-guided iTBS targeting the left DLPFC, while the sham group receives stimulation using the Beam F3 manual method. The iTBS treatment involves 20-minute sessions twice a day for five days a week over two weeks, totaling 10 days of treatment. The active group’s stimulation uses a neuro-modulation protocol with precise coil positioning guided by MRI, while the sham group uses a standardized cap placement method. During the study, participants complete behavioral tasks and EEG recordings before and after the two-week treatment to measure changes in attention and brain activity. Depression severity is assessed 60 to 90 minutes before the first and after the last iTBS treatments. Researchers also analyze changes in brain connectivity and event-related potentials related to the cognitive tasks. The study runs from January 2024 to December 2028 and involves careful monitoring and comparisons between the two stimulation methods to evaluate their impact on selective attention in MDD.

CONDITIONS

Brief Title

Neuromodulation and Attention Deficits in MDD

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 55 years
  • Right-handed
  • Normal or corrected normal vision
  • Diagnosed with Major Depressive Disorder according to DSM-5 criteria
  • Unmedicated or stably medicated for at least one month
  • Healthy subjects without any past or present psychiatric or neurological disorders (for control group)
Not Eligible

You will not qualify if you...

  • Diagnosis of severe mental disorders such as schizophrenia, bipolar disorder, or neurodevelopmental disorders
  • High suicidal risk
  • Intellectual impairments or auditory problems
  • Received neuromodulation treatments like Modified Electroconvulsive Therapy or psychotherapy within the past 6 months
  • For active iTBS group: contraindications for MRI such as metal implants or claustrophobia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 2 weeks

Participants receive intermittent theta burst stimulation (iTBS) intervention targeting the left dorsolateral prefrontal cortex using neuronavigation or the Beam F3 method. Treatment is administered twice daily for 20 minutes per session, for five consecutive days per week, over two weeks.

10 treatment days with 2 sessions per day

Follow-up

Duration - Immediately before and after the 2-week treatment period

Participants are assessed for changes in depression severity, brain connectivity, behavioral performance, and neurophysiological responses before and after the iTBS intervention.

2 visits (pre- and post-treatment assessments)

Trial Site Locations

Total: 1 location

1

The Clinical Hospital of Chengdu Brain Science Institute, Chengdu Fourth People's Hospital, Jiujiang Branch (Chengdu Mental Health Center)

Chengdu, Sichuan, China, 610041

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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