Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04831424
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2021-03-31
Brief Title:
Mitochondrial Stress Brain Imaging and Epigenetics
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
The Mitochondrial Stress Brain Imaging and Epigenetics Study
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study is on pause
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MiSBIE
Brief Summary:
The MiSBIE study collects biological behavioral psychosocial neuropsychological and brain imaging data in participants with either normal mitochondrial function individuals with the m3243AG 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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01MH122706 | NIH | None | httpsreporternihgovquickSearch5R01MH122706 |