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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Kernel
Study ID
NCT07294924
Status
Recruiting
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Conditions

  • Major Depressive Disorder (MDD)
  • fNIRS

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • fNIRS measurement — OTHER
    Kernel Flow is a non-invasive neuroimaging device that uses time-domain functional near-infrared spectroscopy (TD-fNIRS) to measure changes in cortical hemodynamics associated with brain activity.

Study Details

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.

Key Dates

Start date
Dec 15, 2025
Status verified
Dec 2025
Primary completion
Dec 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Accelerated TMS Cohort
    Participants who have previously been diagnosed with MDD and have elected to undergo accelerated TMS to treat their depression at a participating clinic will be enrolled in the study.
  • Arm: Healthy Controls Cohort
    Participants with no diagnosis of depression and no depression-related treatment within the past year will be enrolled as the control group.

Primary Outcome Measure

TD-fNIRS Biomarkers of Treatment Response and Group Differences [ Time Frame: Up to 20 minutes during each study visit ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
KernelLos AngelesCalifornia90232
Katherine Perdue, PhD (PRINCIPAL_INVESTIGATOR)
Acacia ClinicsSunnyvaleCalifornia94087
Noah DeGaetano, MD (SUB_INVESTIGATOR)

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By research site
Kernel· Los Angeles, CAAcacia Clinics· Sunnyvale, CA

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