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

NCT07294924 | Recruiting

• 1 other identifier: KER2025-1-PREDICT-ACC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

fNIRS; Major Depressive Disorder (MDD)

Keywords

Accelerated TMS; Healthy Controls; Observational; Longitudinal; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• 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: 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

  Up to 20 minutes during each study visit

Study Arms (2)

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

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

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.

Also known as: Kernel Flow

Accelerated TMS Cohort; Healthy Controls Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kernel: lead
• Acacia Clinics: collaborator

Study Sites (2)

Kernel

Los Angeles, California, 90232, United States

NOT YET RECRUITING

Acacia Clinics

Sunnyvale, California, 94087, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Katherine Perdue, PhD

  Kernel

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

US (2)