RecruitingNCT07294924

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

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

Sponsor

Kernel

Enrollment

100 participants

Start Date

Dec 15, 2025

Study Type

OBSERVATIONAL

Conditions

Major Depressive Disorder (MDD)fNIRS

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study uses brain-monitoring technology called TD-fNIRS (a type of light-based brain scan) to predict which patients with depression will respond best to a treatment called accelerated repetitive TMS — a non-invasive brain stimulation therapy. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with major depressive disorder (MDD) by a clinician - Your clinic has determined you are a good candidate for accelerated TMS treatment - You are willing to start TMS treatment within the required timeframe **You may NOT be eligible if...** - You have implanted metal devices in your head or neck (such as a pacemaker or cochlear implant) - You have a history of seizures or epilepsy - You are currently pregnant - You have another primary psychiatric diagnosis besides depression Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERfNIRS 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.