Actively Recruiting
Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements
Led by Kernel · Updated on 2025-12-19
100
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
K
Kernel
Lead Sponsor
A
Acacia Clinics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years at enrollment
- Primary diagnosis of Major Depressive Disorder (MDD) as defined by DSM-5
- Eligible and agree to receive accelerated rTMS treatment
- Agree to start accelerated rTMS treatment alongside study participation
- No rTMS treatment in the past 1 month
- No SPRAVATO treatment in the past 1 month
- Can speak and understand English
- Able to provide informed consent
- Healthy controls: adults aged 18 to 75 years
- Healthy controls: can speak and understand English
- Healthy controls: able to provide informed consent
You will not qualify if you...
- Pregnant or may become pregnant during treatment
- Unable or unwilling to wear the fNIRS headset
- Received electroconvulsive therapy (ECT) in the past 3 months
- Major medical illnesses including neurological or psychiatric conditions such as Alzheimer's, Parkinson's, multiple sclerosis, epilepsy, schizophrenia, or stroke
- Any other significant medical condition affecting safety or ability to comply
- Not considered appropriate candidate by study investigators
- Healthy controls only: clinical diagnosis of depression in past year
- Healthy controls only: received treatment for depression in past year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Kernel
Los Angeles, California, United States, 90232
Not Yet Recruiting
2
Acacia Clinics
Sunnyvale, California, United States, 94087
Actively Recruiting
Research Team
K
Katherine Perdue, PhD VP, Applied Science & Clinical Research, PhD
CONTACT
M
Moriah Taylor Research Project Manager
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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