NCT07294924 · Kernel
Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements
(PREDICT-ACC)
What this study is about
This observational, longitudinal, multi-group of participants study aims to evaluate functional brain activity in adults undergoing treatment for Major Depressive Disorder (MDD) at participating clinical sites. A separate group of participants of healthy adults will be enrolled as a control group.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
- Sunnyvale, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 19, 2025 · Source of record for eligibility and locations