Major Depression DisorderNCT07111169
Neuromodulation and Attention Deficits in MDD
A study testing intermittent theta burst stimulation (iTBS) intervention in people with Major Depression Disorder and Cognitive Deficits, run by University of Electronic Science and Technology of China at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depression Disorder, Cognitive Deficits, Selective Attention
- What is being tested?
- intermittent theta burst stimulation (iTBS) intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Clinical Hospital of Chengdu Brain Science Institute, Chengdu Fourth People's Hospital, Jiujiang Branch (Chengdu Mental Health Center)
Chengdu, Sichuan, 610041
Nan Qiu, PhD, 86 18380456153, shirleyqiunan@gmail.com
Lan Hu, PhD, 86 02887038120
About this study
Official title: Selective Attention Deficits and Neuromodulation in Major Depressive Disorder: Using EEG and MRI-guided iTBS Study
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.
Read the 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.
- Being tested
- intermittent theta burst stimulation (iTBS) intervention
- Keywords
- iTBS, EEG, MDD
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent theta burst stimulation (iTBS) interventionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: intermittent theta burst stimulation (iTBS) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Neuromodulation-induced iTBS changes will be measured by the probability cueing effects in the additional singleton task with ERP effects. N2pc and Pd components will be used to quantify attentional selection and distractor suppression. These ERP components reflect the neural mechanisms of spatial attention in MDD.
Measured: 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.
During the additional singleton task, we will measure network-level connectivity patterns between attention-related brain regions (e.g., fronto-parietal and sensory integration systems). Directed or undirected EEG connectivity methods (e.g., phase synchronization, Granger causality, or sPDC) will be applied to assess iTBS-induced changes in intrinsic attentional network architecture in MDD.
Measured: 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.
Neuromodulation-induced iTBS changes will also be measured in RTs. We aim to examine whether the different RT effects in both groups occur between the pre-iTBS and post-iTBS conditions. For the between-group effect, compared to the sham-iTBS group, the active-iTBS group has faster RTs and statistical learning effects (e.g., subtraction RTs from the low-minus-high-probability distractor locations).
Measured: 30-60 minutes before the first iTBS treatment and 30-60 minutes after the last iTBS treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Jan 2024
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depression DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Becker, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111169
- Sponsor's protocol ID
- BAM_lab_MDD_01
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Attention Deficits and Neuromodulation in Major Depressive Disorder: Using EEG and MRI-guided iTBS Study
- ClinicalTrials.gov ID
- NCT07111169
- Acronym / sponsor ID
- BAM_lab_MDD_01
- Keywords
- iTBS, EEG, MDD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDD subjects in the active group undergo 10 days of MRI-guided iTBS intervention | Experimental | Device: intermittent theta burst stimulation (iTBS) interventionNeuronavigation 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. |
| MDD controls in the sham-iTBS group receive the same intervention but Beam F3 site. | Sham comparator | Device: intermittent theta burst stimulation (iTBS) interventionTarget 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intermittent theta burst stimulation (iTBS) interventioniTBS 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. | Device | 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 |
Primary outcome
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.
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Clinical Hospital of Chengdu Brain Science Institute, Chengdu Fourth People's Hospital, Jiujiang Branch (Chengdu Mental Health Center)
Chengdu, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent theta burst stimulation (iTBS) intervention in people with Major Depression Disorder and Cognitive Deficits, run by University of Electronic Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.