Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06897670

Conditions

Major Depressive Disorder

Bipolar Disorder

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels.

Study Details

Brief summary:

The purpose of this research is to measure brain activity in individuals with mood disorders and memory problems using a simple, safe, and noninvasive method called functional near-infrared spectroscopy (fNIRS). By comparing brain activity across different groups and relating it to symptom severity, this study aims to improve our understanding of how these conditions affect the brain.

Conditions

Major Depressive Disorder

Bipolar Disorder

Mild Cognitive Impairment

Study ID

NCT06897670

Start date

Mar 26, 2025

Status verified date

Apr, 2026

Completion date

Mar 30, 2028

Anticipated

Primary completion date

Mar 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

General Inclusion Criteria (across all diagnostic groups):

  • 18 years and older
  • Ability to provide written informed consent
  • Adequate cognitive and language abilities to understand and complete study tasks, including clinical assessments and fNIRS procedures
  • Confirmed clinical diagnosis of major depressive disorder, bipolar disorder, or mild cognitive impairment (MCI)
  • Stable psychiatric or cognitive condition, without acute episodes requiring immediate intervention

Specific Inclusion Criteria (for diagnostic groups):

  • Healthy control

o No past or current psychiatric or cognitive disorder
  • Major depressive disorder (MDD):

  • Diagnosis of major depressive disorder, confirmed through clinical evaluation.
  • No history of bipolar disorder or psychotic symptoms.
  • Bipolar disorder:

o Diagnosis of bipolar disorder I or II, confirmed through clinical evaluation.
  • Mild Cognitive Impairment (MCI):

  • Pre-existing clinical diagnosis of mild cognitive impairment, supported by neuropsychological testing and/or MRI, PET scan data.
  • No history of major psychiatric disorders, such as major depression, bipolar disorder or schizophrenia.

Exclusion Criteria

General Exclusion Criteria (across all diagnostic groups):

  • Active primary psychotic or substance use disorders (except nicotine dependence) within the past year
  • Any severe or unstable medical condition that could interfere with participation or data collection
  • Any active neurological condition (including seizure disorder, traumatic brain injury, stroke) that could affect cognitive functioning or brain imaging results
  • Inability to comply with study procedures, including cognitive testing, fNIRS assessment, or other assessments required by the protocol
  • Pregnant women will be excluded due to potential physiological changes that could affect study outcomes

Specific Exclusion Criteria (for diagnostic groups):

  • Healthy control

o Any past or current psychiatric or cognitive disorder
  • Major depressive disorder (MDD):

  • Diagnosis of bipolar disorder or schizophrenia.
  • Brain stimulation therapy within the past 3 months.
  • Bipolar disorder:

o Diagnosis of schizophrenia or schizoaffective disorder.
  • Mild Cognitive Impairment (MCI):

  • Diagnosis of dementia.
  • Significant cognitive impairment preventing understanding or completion of study tasks.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Controls

o No past or current psychiatric or cognitive disorder.

Major Depressive Disorder

  • Diagnosis of major depressive disorder, confirmed through clinical evaluation.
  • No history of bipolar disorder or psychotic symptoms.

Bipolar Disorder

o Diagnosis of bipolar disorder I or II, confirmed through clinical evaluation.

Mild Cognitive Impairment (MCI)

  • Pre-existing clinical diagnosis of mild cognitive impairment, supported by neuropsychological testing and/or MRI, PET scan data.
  • No history of major psychiatric disorders, such as major depression, bipolar disorder or schizophrenia.

Interventions

Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels.

Functional near-infrared spectroscopy (fNIRS) transcutaneously measures changes in oxyhemoglobin in the prefrontal cortex using light detection. It is designed to measure variations in cerebral hemodynamics on a real-time basis by radiating a near light beam, at two wavelengths of 780nm and 850nm of laser, into the cerebral cortex.

Participants will undergo a one-time functional near-infrared spectroscopy (fNIRS) procedure to measure cerebral hemodynamic patterns.

  • Resting-State Measurement: 5-10 min resting-state scans.
  • Task-Based Measurement: Participants will be shown an instruction video. Participants will complete a Verbal Fluency Task (VFT) during the fNIRS scan (15-20 min).
  • During the fNIRS scan, optional basic vital signs will be measured using respiratory belts, photoplethysmography (PPG), and electrocardiogram (ECG).
  • Each participant will complete 3 sets of resting-state and task-based measurements.

Total estimated time for fNIRS assessment: 45-60 min.

Primary outcome measure

  • Changes in oxyhemoglobin [ Time Frame: Baseline, 60 minutes ]

Central Contacts and Locations

Central contacts

Sarah M. Williams

507-422-2972Williams.Sarah2@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Sarah M. Williams

507-422-2972

Principal Investigator:

Maria I. Lapid, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • functional near-infrared spectroscopy
  • diagnostics
  • mood disorders
  • mild cognitive impairment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-29.