fNIRS, Major Depressive Disorder (MDD)
Conditions
Keywords
Accelerated TMS, Healthy Controls, Observational, Longitudinal, Neuroimaging
Brief summary
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.
Interventions
OTHERfNIRS 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.
Sponsors
Kernel
Acacia Clinics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TD-fNIRS Biomarkers of Treatment Response and Group Differences | Baseline and 1-month after baseline | To gather hemodynamic data with TD-fNIRS and develop biomarkers of depression treatment response and group differences between patients and controls. Candidate markers to relate to clinician assessments are: 1. Local changes in neural activity during Resting State and Task; 2. Functional Connectivity during Resting State and Task; 3. Patterns of Hemodynamic Responses During Emotional, and/or Verbal Fluency Tasks |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKatherine Perdue, PhD
Kernel
Outcome results
None listed