Mitochondrial Stress, Brain Imaging, and Epigenetics (MiSBIE)

  • End date
    Apr 30, 2025
  • participants needed
  • sponsor
    Columbia University
Updated on 4 October 2022
Accepts healthy volunteers


The MiSBIE study collects biological, behavioral, psychosocial, neuropsychological, and brain imaging data in participants with either: normal mitochondrial function, individuals with the m.3243A>G mitochondrial DNA (mtDNA) mutation, and individuals a single large-scale mtDNA deletion. These defects induce mitochondrial allostatic load (MAL). The 2-day protocol, plus home-based data collection, will provide a comprehensive assessment of the multi-systemic dysregulation associated with MAL or mitochondrial dysfunction, and the link to physical and mental health-related symptoms.

Aim 1: Determine the influence of MAL on systemic AL biomarkers.

Aim 2: Establish the influence of MAL on stress reactivity profiles.

Aim 3. Examine the association between MAL and psychological functioning.


Age-related physical and cognitive decline, as well as the risk of neurological diseases, are increased by the effects of psychosocial stress. Psychosocial stress triggers neuroendocrine, metabolic, cardiovascular, and inflammatory changes in the body. These changes vary in nature and magnitude between individuals, and are associated with long-term disease risk. However, the biological determinants of the stress response are not well understood.

This project aims to translate the preclinical findings (how mitochondria regulate the different organ systems and major stress response axes are activated during psychological stress) by studying a population of individuals with varying degree of mitochondrial dysfunction, and to test potential neural mechanism, and why some individuals respond more strongly than others to the same stressor.

Each participant will be studied over two consecutive days. Participants will be housed on campus to standardize study conditions. On Day 1, participants will donate blood and saliva, undergo a neuropsychological assessment, and complete questionnaires to assess psychosocial functioning and psychiatric symptoms. After lunch, the investigator will monitor dynamic changes in mental health-related biological outcomes (positive and negative affect, circulating levels of the inflammatory cytokine IL-6, and salivary cortisol) in response to a standardized laboratory challenge. On Day 2, participants will undergo a medical evaluation to assess clinical symptoms and undergo a whole brain neuroimaging session where both resting and stress elicited activity will be measured. A variant of the same stressor as on Day 1 will be used in the neuroimaging session. Participants will then be debriefed, concluding the individuals participation in the study. Participants also complete a home-based saliva and stool collection to examine diurnal variation in salivary hormones, and to examine microbiome composition. This translational project will generate a unique combination of complimentary molecular, cellular, and neuroimaging data that will advance our understanding of the links between mitochondria, the brain, and mental health-related outcomes.

Condition Mitochondrial Diseases
Treatment Trier Social Stress Test
Clinical Study IdentifierNCT04831424
SponsorColumbia University
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Men and women patients between 18 and 55 years of age
Willing to provide saliva samples and have venous catheter installed for blood collection during the hospital visit
Willing to provide informed consent and capacity to consent
Use of effective method of birth control for women of childbearing capacity
English Speaking

Exclusion Criteria

Individuals with cognitive deficit incapable of providing informed consent will not be included
Symptoms of flu or other seasonal infection four weeks preceding hospital visit
Raynaud's syndrome (Raynaud phenomenon)
Involvement in any therapeutic trials listed on, including exercise
Metal inside or outside the body or claustrophobia prohibitive to MRI testing
Diagnosed with mitochondrial disease m.3243A>G, or large scale mtDNA deletion (for healthy controls)
Clear my responses

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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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