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

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

Recruiting
18-75 years
All
Phase N/A

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Overview

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.

Eligibility

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 details
    Major Depressive Disorder (MDD)
    fNIRS

NCT07294924

Kernel

31 January 2026

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