Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Connectomics in Psychiatric Classification

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03967535
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Washington University Early Recognition Center is conducting a research study to examine brain functional connectivity and network patterns in participants with dementia.

Condition or disease Intervention/treatment
Dementia Dementia Alzheimers Frontotemporal Dementia Pick's Disease With Dementia Device: MRI Brain Imaging Behavioral: Mental Health Assessment and Computerized Cognitive Test

Detailed Description:
This study extends the assessment of brain connectivity and function, being conducted in the Human Connectome Project (HCP), to psychiatrically ill populations. The HCP consortium has made significant improvements in MRI instrumentation, data acquisition, preprocessing, and analysis. These improvements are currently providing publicly available data on the structure, function, and connectivity of young adult human (age 22-35) brains at unprecedented spatial resolution, temporal resolution, and accuracy. This study will focus on individuals aged 45-85 years who have a diagnosis of dementia, or are healthy controls. Additionally, similar to the HCP, the investigator will study the effect of genetics on the patterns of brain connectivity in various psychiatric populations. DNA will be collected non-invasively from saliva. Furthermore, this investigator will study cortisol levels in hair samples as an additional assessment to help characterize brain imagining findings.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Connectomics in Psychiatric Classification
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


Group/Cohort Intervention/treatment
Control
Individuals between 45-85 years old with no diagnosis of dementia. No intervention used
Device: MRI Brain Imaging
Up to two Magnetic Resonance Imaging (MRI) scan sessions will be done, altogether totaling just under 3 hours of scanning. MR scanners measure brain anatomy and activity using very strong magnets. No X-rays or radiation are involved.

Behavioral: Mental Health Assessment and Computerized Cognitive Test
Participants will be asked to complete questionnaires and will be asked questions that address a broad range of personal life experiences involving social, occupational, domestic, and other behaviors.

Dementia
Individuals between 45-85 years old with a diagnosis of dementia. No intervention used
Device: MRI Brain Imaging
Up to two Magnetic Resonance Imaging (MRI) scan sessions will be done, altogether totaling just under 3 hours of scanning. MR scanners measure brain anatomy and activity using very strong magnets. No X-rays or radiation are involved.

Behavioral: Mental Health Assessment and Computerized Cognitive Test
Participants will be asked to complete questionnaires and will be asked questions that address a broad range of personal life experiences involving social, occupational, domestic, and other behaviors.




Primary Outcome Measures :
  1. Magnetic Resonance Imaging (MRI) Brain Imaging [ Time Frame: within one month of study enrollment ]
    The current project aims to uncover latent, homogenous, connectivity phenotypes using neuroimaging tools, which are free from the limitations of traditional diagnostic boundaries, and which correlate with clinical characteristics. The investigator will use resting state functional connectivity MRI (rs-fcMRI), diffusion MRI (dMRI) and tract-based spatial statistics (TBSS) to identify brain signatures that cut across psychiatric disorders.


Secondary Outcome Measures :
  1. DNA testing through saliva [ Time Frame: within one month of study enrollment ]
    Saliva samples will be collected from participants for DNA extraction and the development of lymphoblastoid cell lines. DNA is used for research purposes only, for studies assessing brain connectivity.


Other Outcome Measures:
  1. Hair sample for cortisol measurement [ Time Frame: within one month of study enrollment ]
    To see how cortisol levels can help characterize brain imaging findings



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals between the ages of 45-85 with a diagnosis of Dementia.
Criteria

Inclusion Criteria:

  • Ages 45-85
  • Has consented to participate or has an LAR present that has consented to participate
  • DSM-5 diagnosis of Dementia

Exclusion Criteria:

  • Any genetic disorder, such as cystic fibrosis or sickle cell disease
  • Multiple Sclerosis
  • Cerebral Palsy
  • Loss of consciousness for >30 minutes
  • Pregnancy
  • Hospitalization for stroke, brain aneurysm, brain hemorrhage, or subdural hematoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967535


Locations
Layout table for location information
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Christina Pritchard, MSW    314-362-6952    c.pritchard@wustl.edu   
Principal Investigator: Daniel Mamah, MD         
Sponsors and Collaborators
Washington University School of Medicine

Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03967535     History of Changes
Other Study ID Numbers: 201404123
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Frontotemporal Dementia
Alzheimer Disease
Aphasia, Primary Progressive
Pick Disease of the Brain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms