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出境医 / 临床实验 / Connectomics in Psychiatric Classification
Connectomics in Psychiatric Classification
Study Description
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.
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 30 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Connectomics in Psychiatric Classification |
| Actual Study Start Date : | December 1, 2018 |
| Actual Primary Completion Date : | September 5, 2019 |
| Actual Study Completion Date : | September 5, 2019 |
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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:
- Hair sample for cortisol measurement [ Time Frame: within one month of study enrollment ]To see how cortisol levels can help characterize brain imaging findings
Eligibility Criteria
| 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
Contacts and Locations
Locations
| United States, Missouri | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
Sponsors and Collaborators
Washington University School of Medicine
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 26, 2019 | ||||
| First Posted Date | May 30, 2019 | ||||
| Last Update Posted Date | May 19, 2020 | ||||
| Actual Study Start Date | December 1, 2018 | ||||
| Actual Primary Completion Date | September 5, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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.
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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 |
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 |
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| 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 |
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| Intervention |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
30 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Actual Study Completion Date | September 5, 2019 | ||||
| Actual Primary Completion Date | September 5, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 45 Years to 85 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| 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 |
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| IPD Sharing Statement |
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| 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 2020 | ||||
