Mitochondrial Stress, Brain Imaging, and Epigenetics
United States110 participantsStarted 2018-06-12
Plain-language summary
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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 clinicaltrials.gov, 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Average TSST-induced Elevation in Cortisol
Timeframe: Day 1 post challenge (approximately 2 hours)