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NCT Number: NCT07294924

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kernel, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Kernel Flow

Primary outcomes

  1. TD-fNIRS Biomarkers of Treatment Response and Group Differences

    Time frame: Up to 20 minutes during each study visit

    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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

323-238-9225

Moriah Taylor Research Project Manager

CONTACT

[email protected]

323-238-9225

Sponsors and collaborators

Lead sponsor

Kernel

Industry

Collaborators

  • Acacia Clinics

Registry information

Official study title

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

Acronym: PREDICT-ACC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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