Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements
NCT ID: NCT07294924
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-12-15
2026-12-15
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Acacia Clinics
UNKNOWN
Kernel
INDUSTRY
Responsible Party
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Principal Investigators
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Katherine Perdue, PhD
Role: PRINCIPAL_INVESTIGATOR
Kernel
Locations
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Kernel
Los Angeles, California, United States
Acacia Clinics
Sunnyvale, California, United States
Countries
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Central Contacts
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Katherine Perdue, PhD VP, Applied Science & Clinical Research, PhD
Role: CONTACT
Phone: 323-238-9225
Email: [email protected]
Other Identifiers
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KER2025-1-PREDICT-ACC
Identifier Type: -
Identifier Source: org_study_id