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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02868879
Other study ID # 2898
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 25, 2006
Est. completion date September 2019

Study information

Verified date October 2019
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 162
Est. completion date September 2019
Est. primary completion date September 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Quantitative multiparametric and functional MRI
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.

Locations

Country Name City State
France Service de Psychiatrie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in structural and functional connectivity according to the phenotype. Correlation between these changes 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). Subjects will be assessed only once.
Secondary Changes in rCBF and cognition according to the phenotype. Correlation between the different changes and the symptomatic scales. 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.
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