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Early Brainwave Biomarkers for Personalized Neuromodulation in Treatment-resistant Depression

Early TMS-EEG Potentials as Biomarkers for Personalized Neuromodulation in Treatment-Resistant Depression (R61 Phase)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

This study tests whether a brain stimulation treatment for depression called intermittent theta burst stimulation (iTBS) can be improved by tailoring it to each individual. A type of brain signal measured with electroencephalography (EEG) after a single pulse of brain stimulation, called an early local TMS-evoked potential (EL-TEP), is used to identify which stimulation settings work best for each participant. The investigators will compare individualized (personalized) iTBS settings to standard (non-personalized) settings and to inactive (sham) stimulation. Participants are adults with treatment-resistant depression.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * Aged 18-65 years * Clinical diagnosis of Major Depressive Disorder (MDD), confirmed by structured clinical interview * Current moderate-to-severe depressive episode (MADRS score ≥ 20) * Moderate-to-severe treatment resistance, assessed using the Maudsley Staging Method * Able to comprehend English sufficiently to complete study procedures and assessments * Able to maintain stable antidepressant regimen or remain medication-free for at least 4 weeks prior to and during the study Exclusion Criteria: * Primary psychiatric diagnosis other than MDD * Contraindications to MRI (e.g., implanted metal) * Conditions or medications that may increase risk associated with TMS * Prior exposure to repetitive TMS (rTMS) * Non-response to electroconvulsive therapy (ECT) * History of psychosurgery for depression * High suicidal risk as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)

Study sites (1)

CA