Using time-domain fNIRS brain measurements to predict response to accelerated rTMS in adults with depression
PREDICT-ACC: Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements
This project will try to see if time-domain fNIRS brain scans plus clinical information can predict which adults with major depression get better after accelerated rTMS, with a separate healthy adult control group for comparison.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Kernel Industry-sponsored |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT07294924 on ClinicalTrials.gov |
What this trial studies
This observational, longitudinal multi-cohort project will collect time-domain fNIRS (TD-fNIRS) measurements at rest and during tasks from adults with major depressive disorder who are starting accelerated rTMS, with scans taken before treatment, after treatment, and at follow-up visits. A separate cohort of healthy adults will undergo similar TD-fNIRS measurements at one visit (with an optional follow-up) to serve as controls. Clinical data and hemodynamic responses will be combined to characterize brain activity patterns and explore candidate biomarkers linked to treatment response. All data are collected for research purposes only and will not change participants' clinical care decisions.
Who should consider this trial
Good fit: Ideal participants are adults aged 18–75 with DSM-5 major depressive disorder who are about to start accelerated rTMS, can wear the fNIRS headset, speak English, and can give informed consent, while a separate healthy cohort includes consent-capable adults 18–75 without major medical or psychiatric illness.
Not a fit: People who are pregnant, have recent ECT, major medical or neurological illness, cannot tolerate the fNIRS headset, or have recently had rTMS or SPRAVATO are excluded and unlikely to benefit from this research program.
Why it matters
Potential benefit: If successful, the findings could help clinicians predict who is likely to respond to accelerated rTMS and guide more personalized treatment choices.
How similar studies have performed: Some prior small neuroimaging studies have linked hemodynamic or functional measures to rTMS outcomes, but combining time-domain fNIRS with accelerated rTMS is relatively novel and remains unproven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California and 1 other locations
- Kernel — Los Angeles, California, United States (Not_yet_recruiting)
- Acacia Clinics — Sunnyvale, California, United States (Recruiting)
Study contacts
- Principal investigator: Katherine Perdue, PhD — Kernel
- Study coordinator: Katherine Perdue, PhD VP, Applied Science & Clinical Research, PhD
- Email: research@kernel.com
- Phone: 323-238-9225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.