Active Repetitive Transcranial Magnetic Stimulation (rTMS) / Depression Major Depressive Disorder / Sham Transcranial Magnetic Stimulation (TMS) · Phase EARLY_PHASE1 Trial

Individualized fMRI-guided TMS for Depression

ClinicalTrials.gov · September 4, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered but not-yet-recruiting Phase 1 trial designed to examine whether individualised fMRI-guided TMS targeting the subgenual anterior cingulate cortex (sgACC) can predict and produce changes in both brain responses and depressive symptoms over 6 weeks compared to sham. No results are yet available; the study is exploratory and mechanistic in character, aiming to establish whether sgACC biomarkers can guide TMS treatment.

What was studied

Early Phase 1, Interventional, Randomized, Parallel, Double masking, Basic Science purpose. Depression, Major Depressive Disorder (MDD), Depression - Major Depressive Disorder, Persistent Depressive Disorder, PDD, MDD; age from 18 Years; to 65 Years. Intervention: Active iTBS. Compared with: Sham iTBS — Sham Comparator. n = 60. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This exploratory trial may establish whether fMRI-guided targeting of sgACC responses can predict TMS treatment response or guide individualised therapy selection; findings could inform future larger trials of biomarker-driven TMS strategies. Clinicians should not alter TMS practice based on this early-phase registration, as results are not yet available.

Plain-language summary

This is an early-phase (Phase 1) interventional trial registration with no posted results; it describes a planned mechanistic study of fMRI-guided TMS targeting a specific brain circuit in depression.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to post-intervention period. (assessed at ~6 weeks); Change in Patient Health Questionnaire-9 (PHQ-9) total score from baseline to post-intervention period follow up. (assessed at ~6 weeks)

DesignEarly Phase 1, Interventional, Randomized, Parallel, Double masking, Basic Science purpose

PopulationDepression, Major Depressive Disorder (MDD), Depression - Major Depressive Disorder, Persistent Depressive Disorder, PDD, MDD; age from 18 Years; to 65 Years

Sample size60

InterventionActive iTBS

ComparatorSham iTBS — Sham Comparator

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned sample size60

Study phaseEARLY_PHASE1

Primary outcome measure 1Change in Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to post-intervention (~6 weeks)

Primary outcome measure 2Change in Patient Health Questionnaire-9 (PHQ-9) total score from baseline to post-intervention (~6 weeks)

Intervention duration6 weeks of weekday active or sham TMS

Clinical bottom line

Caveats

No results are posted; this is a protocol registration only.
Early phase design limits generalisability and clinical applicability; mechanistic endpoints (sgACC fMRI responses) are surrogate, not clinical hard outcomes.
Specific eligibility criteria, randomisation method, blinding procedures, and statistical analysis plan are not detailed in the registry record.
No effect sizes, confidence intervals, or p-values are available; follow-up assessments are mentioned but timing and completion criteria are not specified.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Randomized sham-controlled design planned; early phase limits strength of inference.

Directness

moderate

Clinical outcome measures (MADRS, PHQ-9) with mechanistic neuroimaging endpoints (sgACC responses).

Consistency

insufficient

No results posted; consistency with prior work cannot be assessed from this registry record.

Risk of bias

insufficient

Sham control planned but no details on blinding, allocation concealment, or conduct reported.

Sample adequacy

limited

Estimated 60 participants total; typical for early-phase mechanistic study, underpowered for clinical efficacy.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07804459). This is a study registration, not published results. Lead sponsor: Desmond Oathes. Recruitment status: NOT_YET_RECRUITING. Phase: EARLY_PHASE1. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Depression, Major Depressive Disorder (MDD), Depression - Major Depressive Disorder, Persistent Depressive Disorder, PDD, MDD. Interventions: DEVICE: Active Repetitive Transcranial Magnetic Stimulation (rTMS); DEVICE: Sham Transcranial Magnetic Stimulation (TMS). Primary outcome measures: Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to post-intervention period. , ~6 weeks; Change in Patient Health Questionnaire-9 (PHQ-9) total score from baseline to post-intervention period follow up. , ~6 weeks. Brief summary: The goal of this clinical trial is to learn how transcranial magnetic stimulation (TMS) affects brain circuits involving the subgenual anterior cingulate cortex (sgACC) in adults with depression. The main questions it aims to answer are: * Can brain responses in the sgACC before treatment predict improvement in depressive symptoms following TMS? * Does a 6-week course of active TMS, compared with sham TMS, change brain responses in the sgACC? * Are changes in sgACC responses during treatment associated with changes in depressive symptoms? Researchers will compare active TMS with sham TMS to evaluate changes in the targeted brain circuit and depressive symptoms. Participants will: * Receive active or sham TMS every weekday for 6 weeks * Undergo MRI scans with TMS before, during, and after the 6-week intervention to measure brain responses to stimulation * Complete clinical assessments, questionnaires, and cognitive testing * Complete follow-up assessments after the intervention

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Desmond OathesActive Repetitive Transcranial Magnetic Stimulation (rTMS)Depression Major Depressive DisorderSham Transcranial Magnetic Stimulation (TMS)DepressionNCT07804459Major Depressive Disorder (MDD)