Neuromodulation and Attention Deficits in MDD

NCT07111169 | Recruiting

• 1 other identifier: BAM_lab_MDD_01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depression Disorder; Cognitive Deficits; Selective Attention

Keywords

iTBS; EEG; MDD

Outcome Measures

Primary Outcomes (1)

• Depression severity following two weeks of 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.

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

Secondary Outcomes (3)

• 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.

Study Arms (2)

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.

Device: intermittent theta burst stimulation (iTBS) intervention

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.

Device: intermittent theta burst stimulation (iTBS) intervention

Interventions

intermittent theta burst stimulation (iTBS) intervention DEVICE

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 sessions, and five consecutive days of treatment per week, with a rest of 2 days, and two weeks of treatment.

MDD controls in the sham-iTBS group receive the same intervention but Beam F3 site.; MDD subjects in the active group undergo 10 days of MRI-guided iTBS intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Electronic Science and Technology of China: lead

Study Sites (1)

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

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Cognition Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beckerlab

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 8, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: August 8, 2025

Record last verified: 2025-07

Locations

CN (1)