Connectomics in Psychiatric Classification

Dementia Clinical Trial

Official title:

Connectomics in Psychiatric Classification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967535
• Other study ID #: 201404123
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: September 5, 2019

Study information

• Verified date: May 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 5, 2019
• Est. primary completion date: September 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia, Primary Progressive
• Dementia
• Dementia Alzheimers
• Frontotemporal Dementia
• Pick Disease of the Brain
• Pick's Disease With Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hair sample for cortisol measurement	To see how cortisol levels can help characterize brain imaging findings	within one month of study enrollment
Primary	Magnetic Resonance Imaging (MRI) Brain Imaging	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.	within one month of study enrollment
Secondary	DNA testing through saliva	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.	within one month of study enrollment