Major Depressive Disorder (MDD)PREDICT-ACCNCT07294924

Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements

An observational study of Major Depressive Disorder (MDD) and fNIRS, run by Kernel at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Major Depressive Disorder (MDD), fNIRS
What is being tested?: fNIRS measurement
How many people: 11 participants
Where: 2 sitesUnited States
Study dates: 1 Jan 2026to 12 Mar 2026
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study 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.

Who may be able to join

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

Show all 13Show fewer

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

Who cannot join

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.

Show all 10Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Kernel
Los Angeles, California, 90232
Acacia Clinics
Sunnyvale, California, 94087

Other trials in United States

About this study

Official title: PREDICT-ACC: Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements

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
Being tested: fNIRS measurement
Keywords: Accelerated TMS, Healthy Controls, Observational, Longitudinal, Neuroimaging
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fNIRS measurementOther
Also called Kernel Flow
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.

Study groups in NCT07294924
Study group	Role	What they receive
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. Receives: Other: fNIRS measurement
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. Receives: Other: fNIRS measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline and 1-month after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202612 Mar 2026

First posted19 Dec 2025
Study start1 Jan 2026
Primary completion12 Mar 2026
Study completion12 Mar 2026

Why it stopped: Terminated due to low enrollment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07294924
Sponsor's protocol ID: KER2025-1-PREDICT-ACC
Acronym: PREDICT-ACC
Status last verified: Sep 2026
First submitted: 8 Dec 2025
Last updated: 10 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder (MDD) trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PREDICT-ACC: Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements
ClinicalTrials.gov ID: NCT07294924
Acronym / sponsor ID: PREDICT-ACC / KER2025-1-PREDICT-ACC
Conditions: Major Depressive Disorder (MDD), fNIRS
Keywords: Accelerated TMS, Healthy Controls, Observational, Longitudinal, Neuroimaging
Study type: Observational
Recruitment status: TerminatedReason stopped: Terminated due to low enrollment.
Enrolment: 11 participants (actual)
Lead sponsor: KernelIndustry (pharma, biotech, devices)
Collaborators: Acacia Clinics
Study start: 1 Jan 2026 (actual)
Primary completion: 12 Mar 2026 (actual)
Study completion: 12 Mar 2026 (actual)
First posted: 19 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Accelerated TMS Cohort	–	Other: fNIRS measurementParticipants 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	–	Other: fNIRS measurementParticipants with no diagnosis of depression and no depression-related treatment within the past year will be enrolled as the control group.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study 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.

Key inclusion criteria (13 listed)

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

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fNIRS measurementAlso: Kernel FlowKernel 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	Accelerated TMS Cohort, Healthy Controls Cohort

Primary outcome

TD-fNIRS Biomarkers of Treatment Response and Group Differences
Time frame: 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

Results and safety

The study was stopped early (reason given: Terminated due to low enrollment.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
Individual participant dataSharing planned: Undecided

Related trials for Major Depressive Disorder (MDD)

RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Katherine Perdue, PhD principal investigator

Kernel

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Major Depressive Disorder (MDD) and fNIRS, run by Kernel at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Terminated due to low enrollment.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TD-fNIRS Biomarkers of Treatment Response and Group Differences (time frame: Baseline and 1-month after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07294924.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.