BIP: Study of the Hemispheric Specialization for Language in Subjects With Neuropsychiatric Disorders Compared to Control Subjects

Sponsor

University Hospital, Caen (Other)

Overall Status

Completed

CT.gov ID

NCT02523742

Collaborator

(none)

152

Enrollment

Arms

113.7

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Recently, we have shown functional resonance imaging (fMRI) that variations in signal induced by a language task were significantly lower in a semantic region of the left hemisphere (comprised of that part pars triangularis of the inferior frontal gyrus and the temporal gyri medium and angular) in schizophrenic patients compared with controls matched for age, sex, level of education and handedness.

Investigators wish to test the hypothesis that functional modification of the hemispherical specialization is specific language and also specific for schizophrenia.

Condition or Disease	Intervention/Treatment	Phase
Neuropsychiatric Disorders	Device: IMRf Other: language task and a reference task (rest and Tamil)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

152 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Actual Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Nov 19, 2013

Actual Study Completion Date :

Apr 23, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Neuropsychiatric Disorders Neuropsychiatric Disorders patients	Device: IMRf Other: language task and a reference task (rest and Tamil)
Other: Healthy volunteers control subjects matched to patients by age, sex, socio-cultural level and laterality	Device: IMRf Other: language task and a reference task (rest and Tamil)

Arm

Intervention/Treatment

Other: Neuropsychiatric Disorders

Neuropsychiatric Disorders patients

Device: IMRf

Other: language task and a reference task (rest and Tamil)

Other: Healthy volunteers

control subjects matched to patients by age, sex, socio-cultural level and laterality

Device: IMRf

Other: language task and a reference task (rest and Tamil)

Outcome Measures

Primary Outcome Measures

variation in signal (SPM99) during a language task compared to a reference task (rest or Tamil) in fMRI in anatomical regions of interest [baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

patients under 65 years
Schizophrenics, bipolar or schizoaffective (DSM IV)
Patients who signed informed consent

Exclusion Criteria:

Women with childbearing potential without effective contraception or positive pregnancy test.
Contra-indications to fMRI

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT02523742

Other Study ID Numbers:

05-097

First Posted:

Aug 14, 2015

Last Update Posted:

Sep 1, 2020

Last Verified:

Aug 1, 2015

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 1, 2020