Mitochondrial Stress, Brain Imaging, and Epigenetics

NCT04831424 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-05-20

Study results available
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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.

Conditions

  • Mitochondrial Diseases

Interventions

BEHAVIORAL

Trier social stress test

The Trier social stress test (TSST) is a tool for investigating psychobiological stress responses in a laboratory setting. It is a laboratory procedure used to reliably induce stress in human research participants. The study is not examining or validating the test itself but rather using it as a tool to measure the response/focus of study.

Sponsors & Collaborators

  • Dartmouth College

    collaborator OTHER
  • Centre National de la Recherche Scientifique, France

    collaborator OTHER
  • Massachusetts General Hospital

    collaborator OTHER
  • Technische Universität Dresden

    collaborator OTHER
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Columbia University

    lead OTHER

Principal Investigators

  • Martin Picard, PhD · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-12
Primary Completion
2023-06-30
Completion
2024-05-03

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04831424 on ClinicalTrials.gov