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Recruiting NCT07294924

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

Conditions: Major Depressive Disorder (MDD), fNIRS

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Enrollment: 100
Sponsor: Kernel

Location: Kernel Los Angeles California

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

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07294924). StuddyBuddy aggregates publicly available trial information.