Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorKernel
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
This study includes two cohorts of adults aged 18-75: (1) participants with a primary diagnosis of Major Depressive Disorder (MDD) who are eligible for and agree to undergo accelerated rTMS treatment, and (2) healthy control participants with no depression diagnosis or depression-related treatment in the past year. All participants must be able to provide informed consent, speak English, and meet general safety and eligibility criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
fNIRS measurement
Other interventionKernel 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Accelerated TMS Cohort1 intervention
Group B: Healthy Controls Cohort1 intervention
Trial outcomes
Primary outcomes
1
TD-fNIRS Biomarkers of Treatment Response and Group Differences
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
Time frame
Up to 20 minutes during each study visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kernel
Lead sponsor
Acacia Clinics
Collaborator
Source ClinicalTrials.gov