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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder (MDD); fNIRS
• Intervention / Treatment: Other: fNIRS measurement

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Katherine Perdue, PhD VP, Applied Science & Clinical Research, PhD; Phone Number: 323-238-9225; Email: research@kernel.com
• Study Contact Backup: Name: Moriah Taylor Research Project Manager; Phone Number: 323-238-9225; Email: research@kernel.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90232
      • Not yet recruiting
      • Kernel
      • Principal Investigator: Katherine Perdue, PhD
    • Sunnyvale, California, United States, 94087
      • Recruiting
      • Acacia Clinics
      • Sub-Investigator: Noah DeGaetano, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This study includes two cohorts of adults aged 18-75: (1) participants with a primary diagnosis of Major Depressive Disorder (MDD) who are eligible for and agree to undergo accelerated rTMS treatment, and (2) healthy control participants with no depression diagnosis or depression-related treatment in the past year. All participants must be able to provide informed consent, speak English, and meet general safety and eligibility criteria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: fNIRS measurement; 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.; Other Names: Kernel Flow
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.	Other: fNIRS measurement; 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.; Other Names: Kernel Flow

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TD-fNIRS Biomarkers of Treatment Response and Group Differences	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: Local changes in neural activity during Resting State and Task;; Functional Connectivity during Resting State and Task;; Patterns of Hemodynamic Responses During Emotional, and/or Verbal Fluency Tasks	Up to 20 minutes during each study visit

Collaborators and Investigators

• Sponsor: Kernel
• Collaborators: Acacia Clinics
• Investigators: Principal Investigator: Katherine Perdue, PhD, Kernel

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Observational; Neuroimaging; Longitudinal; Healthy Controls; Accelerated TMS
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: KER2025-1-PREDICT-ACC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No