NCT02523742

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2013

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2015

Enrollment Period

8.1 years

First QC Date

August 13, 2015

Last Update Submit

August 31, 2020

Conditions

Neuropsychiatric Disorders

Outcome Measures

Primary Outcomes (1)

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

    baseline

Study Arms (2)

Neuropsychiatric Disorders

OTHER

Neuropsychiatric Disorders patients

Device: IMRfOther: language task and a reference task (rest and Tamil)

Healthy volunteers

OTHER

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

Device: IMRfOther: language task and a reference task (rest and Tamil)

Interventions

IMRfDEVICE
Healthy volunteersNeuropsychiatric Disorders
language task and a reference task (rest and Tamil)OTHER
Healthy volunteersNeuropsychiatric Disorders

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

RE1-silencing transcription factor

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 14, 2015

Study Start

November 1, 2005

Primary Completion

November 19, 2013

Study Completion

April 23, 2015

Last Updated

September 1, 2020

Record last verified: 2015-08