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Recruiting NCT07294924

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

— Observational Major Depressive Disorder (MDD) fNIRS

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fNIRS measurement.
Who it may be relevant to
Registry conditions: Major Depressive Disorder (MDD), fNIRS. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

  • 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.

Primary outcome measures

  • TD-fNIRS Biomarkers of Treatment Response and Group Differences [Time frame: Baseline and 1-month after baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Kernel — Los Angeles
  • Acacia Clinics — Sunnyvale

Identifiers

NCT: NCT07294924 · KER2025-1-PREDICT-ACC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗