Measuring brain activity in mood disorders and mild cognitive impairment

Identifying Cerebral Hemodynamic Patterns in Mood Disorders and Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy (fNIRS) Study

This study is testing brain activity in people with mood disorders and mild cognitive impairment to see how it relates to their symptoms using a safe and noninvasive method.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mayo Clinic (other)
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT06897670 on ClinicalTrials.gov

What this trial studies

This research aims to assess brain activity in individuals diagnosed with mood disorders, such as major depressive disorder and bipolar disorder, as well as those with mild cognitive impairment, using a noninvasive technique called functional near-infrared spectroscopy (fNIRS). The study will compare cerebral hemodynamic patterns across these groups and investigate how these patterns correlate with the severity of their symptoms. Additionally, it will analyze autonomic nervous system activity through electrophysiological data, including photoplethysmography and electrocardiogram readings, to provide a comprehensive understanding of brain function in these conditions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of major depressive disorder, bipolar disorder, or mild cognitive impairment.

Not a fit: Patients with acute psychiatric or cognitive episodes requiring immediate intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance diagnostic accuracy and treatment strategies for patients with mood disorders and mild cognitive impairment.

How similar studies have performed: Previous studies using fNIRS have shown promise in understanding brain function in mood disorders, suggesting this approach may yield valuable insights.

Eligibility criteria

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.

Where this trial is running

Rochester, Minnesota

• Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)

Study contacts

• Principal investigator: Maria I. Lapid, M.D. — Mayo Clinic
• Study coordinator: Sarah M. Williams

Conditions: Major Depressive Disorder, Bipolar Disorder, Mild Cognitive Impairment, functional near-infrared spectroscopy, diagnostics, mood disorders, mild cognitive impairment