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

RecruitingN/A

Sponsor: Kernel

Conditions: Major Depressive Disorder (MDD), fNIRS

Interventions: fNIRS measurement

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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

Locations (2)

Los Angeles, California, United States
Sunnyvale, California, United States