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

ArmDescriptionAssigned 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.
  • Other: fNIRS measurement
    Kernel Flow is a non-invasive neuroimaging device that uses time-domain functional near-infrared spectroscopy (TD-fNIRS) to measure changes in cortical hemodynamics associated with brain activity.
    Other names:
    • Kernel Flow
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.
  • Other: fNIRS measurement
    Kernel Flow is a non-invasive neuroimaging device that uses time-domain functional near-infrared spectroscopy (TD-fNIRS) to measure changes in cortical hemodynamics associated with brain activity.
    Other names:
    • Kernel Flow

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Kernel

Study Contact

Katherine Perdue, PhD VP, Applied Science & Clinical Research, PhD
323-238-9225
research@kernel.com