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NCT07294924RecruitingAccepts Healthy Volunteers

Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements

Kernel

Start Date

12/15/2025

Completion Date

12/15/2026

Summary

This observational, longitudinal, multi-cohort study aims to evaluate functional brain activity in adults undergoing treatment for Major Depressive Disorder (MDD) at participating clinical sites. A separate cohort of healthy adults will be enrolled as a control group. All data collected in this study are for research purposes only and will not influence clinical decision-making or treatment plans. This study will use TD-fNIRS to measure hemodynamic brain responses at rest and/or during tasks in patients receiving accelerated transcranial magnetic stimulation (TMS). Imaging will occur at multiple timepoints (pre-treatment, post-treatment, and follow-ups). Healthy control participants will complete similar measurements at one visit, with the option for a follow-up visit. The primary objectives are to assess feasibility, characterize brain activity patterns, and explore potential biomarkers associated with treatment response.

Eligibility Criteria

Age Range: 18 years to 75 years

Inclusion Criteria for: Accelerated TMS cohort * Adults aged 18-75 at the time of enrollment * Primary diagnosis of MDD as defined by the DSM-5 * Determined by the clinic to be eligible for accelerated rTMS treatment and agrees to receive accelerated rTMS treatment * Agrees to start accelerated rTMS treatment in conjunction with study participation to capture baseline measurements * Has not received rTMS treatment in the past 1 month * Has not received SPRAVATO treatment in the past 1 month * Can speak and understand English * Ability to provide informed consent Healthy controls cohort * Adults aged 18-75 at time of enrollment * Can speak and understand English * Ability to provide informed consent Exclusion Criteria for: All cohorts * Pregnant or may become pregnant during the treatment course * Unable or unwilling to wear the fNIRS headset * Has had electroconvulsive therapy (ECT) in the past 3 months * Major medical illnesses including neurological and psychiatric conditions such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, epilepsy, schizophrenia, or stroke. * Any other clinically significant medical condition that in the opinion of the clinician or study team, could affect patient safety, wellbeing, or the participant's ability to comply with study procedures. * Not an appropriate candidate for the study based on the discretion of the study investigator(s). Healthy controls cohort only * Clinical diagnosis of depression in the past year * Undergoing any treatments for depression in the past year

Interventions

OTHER

fNIRS measurement

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Conditions

Major Depressive Disorder (MDD)fNIRS

Locations

Kernel

Los Angeles, California 90232

United States

Acacia Clinics

Sunnyvale, California 94087

United States