Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements
Purpose
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
- Major Depressive Disorder (MDD)
- fNIRS
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Accelerated TMS Cohort | Participants who have previously been diagnosed with MDD and have elected to undergo accelerated TMS to treat their depression at a participating clinic will be enrolled in the study. |
|
| Healthy Controls Cohort | Participants with no diagnosis of depression and no depression-related treatment within the past year will be enrolled as the control group. |
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Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Kernel
Study Contact
Katherine Perdue, PhD VP, Applied Science & Clinical Research, PhD323-238-9225
research@kernel.com