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

Tracking Information
First Submitted Date May 26, 2019
First Posted Date May 30, 2019
Last Update Posted Date May 30, 2019
Actual Study Start Date December 1, 2018
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 26, 2019)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 26, 2019)
Hair sample for cortisol measurement [ Time Frame: within one month of study enrollment ]
To see how cortisol levels can help characterize brain imaging findings
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Connectomics in Psychiatric Classification
Official Title Connectomics in Psychiatric Classification
Brief Summary Washington University Early Recognition Center is conducting a research study to examine brain functional connectivity and network patterns in participants with dementia.
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Individuals between the ages of 45-85 with a diagnosis of Dementia.
Condition
  • Dementia
  • Dementia Alzheimers
  • Frontotemporal Dementia
  • 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.
Study Groups/Cohorts
  • Control
    Individuals between 45-85 years old with no diagnosis of dementia. No intervention used
    Interventions:
    • Device: MRI Brain Imaging
    • Behavioral: Mental Health Assessment and Computerized Cognitive Test
  • Dementia
    Individuals between 45-85 years old with a diagnosis of dementia. No intervention used
    Interventions:
    • Device: MRI Brain Imaging
    • Behavioral: Mental Health Assessment and Computerized Cognitive Test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 26, 2019)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03967535
Other Study ID Numbers 201404123
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor Washington University School of Medicine
Collaborators Not Provided
Investigators Not Provided
PRS Account Washington University School of Medicine
Verification Date May 2019