Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements
Recruiting · NCT07294924 · Observational (researchers observe without assigning treatment) · Lead sponsor: Kernel
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 it is running
2 locations listed across 1 US state.
- Kernel - Los Angeles, California, United States
- Acacia Clinics - Sunnyvale, California, United States