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

RECRUITING

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

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

NCT07294924•Kernel

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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
+3 more criteria

Exclusion Criteria

•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)

Kernel

Los Angeles, California, United States

Acacia Clinics

Sunnyvale, California, United States

Key Dates

Start Date

December 15, 2025

Primary Completion Date

December 15, 2026

Completion Date

December 15, 2026

Last Updated

December 19, 2025

Enrollment

100

ESTIMATED participants

Conditions

Major Depressive Disorder (MDD)fNIRS

Interventions

fNIRS measurement

OTHER

Contacts

Katherine Perdue, PhD VP, Applied Science & Clinical Research, PhD

CONTACT

323-238-9225 research@kernel.com

Moriah Taylor Research Project Manager

CONTACT

323-238-9225 research@kernel.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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