Study of the Hemispheric Specialization for Language in Subjects With Neuropsychiatric Disorders Compared to Control Subjects (BIP)
August 31, 2020 updated by: University Hospital, Caen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
152
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Neuropsychiatric Disorders
Neuropsychiatric Disorders patients
|
|
|
Other: Healthy volunteers
control subjects matched to patients by age, sex, socio-cultural level and laterality
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
variation in signal (SPM99) during a language task compared to a reference task (rest or Tamil) in fMRI in anatomical regions of interest
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2005
Primary Completion (Actual)
November 19, 2013
Study Completion (Actual)
April 23, 2015
Study Registration Dates
First Submitted
August 13, 2015
First Submitted That Met QC Criteria
August 13, 2015
First Posted (Estimate)
August 14, 2015
Study Record Updates
Last Update Posted (Actual)
September 1, 2020
Last Update Submitted That Met QC Criteria
August 31, 2020
Last Verified
August 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 05-097
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Neuropsychiatric Disorders
-
University Hospital, Strasbourg, FranceActive, not recruitingNeuropsychiatric DisordersFrance
-
Brain Inflammation CollaborativeUniversity of California, Los Angeles; Stanford UniversityCompletedPANDAS | PANS | Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections | Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) | PANS Pediatric Acute-Onset Neuropsychiatric Syndrome | Pediatric Acute-Onset Neuropsychiatric SyndromeUnited States
-
University of Texas at AustinCompletedHealthy Subjects | Neuropsychiatric DisordersUnited States
-
IMMUNOe Research CentersOctapharmaUnknownPediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections | Pediatric Acute-Onset Neuropsychiatric SyndromeUnited States
-
National Institute of Mental Health (NIMH)TerminatedPediatric Acute-onset Neuropsychiatric Syndrome (PANS)United States
-
Göteborg UniversityCompletedPANS Pediatric Acute-Onset Neuropsychiatric SyndromeSweden
-
Stanford UniversityRecruitingPANDAS | PANS | Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections | Pediatric Acute-Onset Neuropsychiatric SyndromeUnited States
-
Fenix Innovation GroupNeurotech InternationalActive, not recruitingPANS Pediatric Acute-Onset Neuropsychiatric SyndromeAustralia
-
OctapharmaCompletedPediatric Acute-Onset Neuropsychiatric SyndromeUnited States, Italy, Sweden
-
Karolinska InstitutetThe Swedish Research CouncilCompletedPANDAS | Obsessive-compulsive Disorder | Obsessive-compulsive Disorder With Acute Onset | Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections | Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) | Childhood Acute Neuropsychiatric Symptoms (CANS)Sweden