Recruiting

TMS

Sponsor:

Kernel

Code:

NCT07294924

Conditions

Major Depressive Disorder (MDD)

fNIRS

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

fNIRS measurement

Study Details

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.

Conditions

Major Depressive Disorder (MDD)

fNIRS

Study ID

NCT07294924

Start date

Jan 1, 2026

Status verified date

Aug, 2026

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • TD-fNIRS Biomarkers of Treatment Response and Group Differences [ Time Frame: Baseline and 1-month after baseline ]

Central Contacts and Locations

Central contacts

Katherine Perdue, PhD VP, Applied Science & Clinical Research, PhD

323-238-9225research@kernel.com

Moriah Taylor Research Project Manager

323-238-9225research@kernel.com

Locations

Acacia Clinics

Recruiting

Sunnyvale, California, United States, 94087

More Information

Sponsor

Kernel

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • Accelerated TMS
  • Healthy Controls
  • Observational
  • Longitudinal
  • Neuroimaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kernel on 2026-08-05.