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Observational Study on Brain Activity and Depression Treatment

This study is looking at how brain activity changes in adults receiving accelerated transcranial magnetic stimulation (rTMS) for Major Depressive Disorder (MDD). Researchers will use a non-invasive device called Kernel Flow, which uses time-domain functional near-infrared spectroscopy (TD-fNIRS), to measure blood flow in your brain. This helps them understand how your brain responds to treatment. They are also enrolling a group of healthy adults for comparison. The goal is to find patterns in brain activity that might predict how well someone will respond to accelerated rTMS. This is an observational study, meaning the measurements are for research only and won't affect your treatment plan. You may be eligible if you are 18-75 years old, have MDD, and are already planning to receive accelerated rTMS.

Study design
This is an observational study involving 100 participants, including adults with MDD receiving accelerated rTMS and a separate group of healthy adults.
What's involved
If you have MDD, you will have TD-fNIRS measurements taken before, during, and after your accelerated rTMS treatment, and at follow-up visits. Healthy control participants will have similar measurements at one visit, with an option for a follow-up.
Compensation
Not stated in the trial record.
Follow-up
Measurements will be taken at multiple timepoints, including pre-treatment, post-treatment, and follow-ups. The exact duration of follow-up is not specified.

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NCT07294924

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

Recruiting
Not specifiedAges 18–75Observational
Kernel
~100 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:fNIRS measurement

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
TD-fNIRS Biomarkers of Treatment Response and Group Differences
Measured over Baseline and 1-month after baseline

Conditions

Major Depressive Disorder (MDD)
fNIRS

Explore related trials

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Where it's being run

2 sites across 1 states
California2

Study leadership

  • Katherine Perdue, PhD · PRINCIPAL_INVESTIGATOR · Kernel

Who to contact

Katherine Perdue, PhD VP, Applied Science & Clinical Research, PhD
[email protected]
323-238-9225
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Adults aged 18-75 at time of enrollment
Can speak and understand English
Ability to provide informed consent

Exclusion

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).
Clinical diagnosis of depression in the past year
Undergoing any treatments for depression in the past year

What this trial measures

  • TD-fNIRS Biomarkers of Treatment Response and Group DifferencesBaseline and 1-month after baseline

    To gather hemodynamic data with TD-fNIRS and develop biomarkers of depression treatment response and group differences between patients and controls. Candidate markers to relate to clinician assessments are: 1. Local changes in neural activity during Resting State and Task; 2. Functional Connectivity during Resting State and Task; 3. Patterns of Hemodynamic Responses During Emotional, and/or Verbal Fluency Tasks