- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02868879
Anatomical and Structural Connectivity in Two Psychotic Phenotypes : Periodic Catatonia and Cataphasia
Anatomical and Structural Connectivity in Schizophrenias
The different subtypes of Schizophrenia might have a disordered connectivity as their final common pathways.
The investigators will use multimodal structural MRI to assess anatomical connectivity on the one side and its functional consequence on functional connectivity on the other side to assess two phenotypes of psychosis : periodic catatonia and cataphasia in comparison with control subjects.
The coherence between structural and functional anomalies will be especially studied.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Strasbourg, France, 67091
- Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria (controls):
- Aged from 18-65 Y
- Right handed
Additional inclusion criteria for patients:
- Schizophrenia according to the DSM5
- Either periodic catatonia or cataphasia according to the WKL classification
- Under stable medication regimen (> 1M)
Exclusion criteria:
- Current substance abuse
- Contraindication to MRI
- Past records susceptible to affect brain integrity
- Severe, unstable medical condition
- Pregnancy
- Patients deprived of their rights
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Schizophrenia
|
Structural connectivity assessed in the cortex and the white matter using multimodal quantitative parametric imaging (R1, R2, R2*, DTI, susceptibility, macromolecular proton fraction, cortical thickness, VBM). Functional connectivity assessed using simple BOLD and combined ASL-BOLD sequences during multiple tasks including motor, language and working memory tasks. |
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Normal controls.
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Structural connectivity assessed in the cortex and the white matter using multimodal quantitative parametric imaging (R1, R2, R2*, DTI, susceptibility, macromolecular proton fraction, cortical thickness, VBM). Functional connectivity assessed using simple BOLD and combined ASL-BOLD sequences during multiple tasks including motor, language and working memory tasks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in structural and functional connectivity according to the phenotype. Correlation between these changes
Time Frame: Subjects will be assessed only once.
|
Statistical parametric mapping (SPM) will be applied on quantitative maps : rCBF (ml/100g/min), susceptibility (part per billion), R1, R2, R2* (all expressed in ms-1), fractional anisotropy (fraction), averaged diffusivity (μm²/sec), macromolecular proton fraction (percentage), cortical thickness (mm), VBM (probability of grey and white matter) and contrast maps (BOLD signal correlation with the anterior cingulate ROI).
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Subjects will be assessed only once.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in rCBF and cognition according to the phenotype. Correlation between the different changes and the symptomatic scales.
Time Frame: Subjects will be assessed only once.
|
Symptomatic scales : PANSS, SANS, SAPS, Calgary, Bush and Francis catatonia scale, the psychological experimental test operationalized for cataphasia, Clinician-rated dimension of psychosis symptom severity questionnaire assessing handedness, anhedonia, vigilance, QoL, activity, handicap, ruminations, depression and personality. Cognitive tests : grammar tests, semantic priming, implicit memory, CPT, fNART, Mill-Hill (part B) |
Subjects will be assessed only once.
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2898
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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