Functional Magnetic Resonance Imaging Study in Schizophrenia Patients and Correlation With Cognitive Impairments

July 29, 2024 updated by: waleed ashraf hamdy ahmed, Assiut University

Functional Magnetic Resonance Imaging Study of Schizophrenic Patients and Its Correlation With Cognitive Impairments

  1. Comparison of functional activity at different brain areas related to different cognitive domains e.g. Memory, visuospatial abilities, executive functions, attention, concentration, language, orientation in schizophrenia to healthy subjects.
  2. Correlation with resting functional activity at brain areas with clinical deterioration in cognitive functions.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Schizophrenia represents a multifaceted clinical challenge. Patients' outcome is still highly heterogeneous and poor. Cognitive impairment, a central feature of the illness is present in over 80% of patients with schizophrenia, is a main functional disability. Currently available antipsychotics have only limited effects on cognition and side effects may even aggravate some deficits. So far, pharmacological options for cognitive deficits in schizophrenia are unsatisfactory due to either limited efficacy or tolerability concerns. Understanding the quality, quantity of brain changes could cover patterns of potential therapeutic relevance, guiding treatments. Understanding the pathophysiology of impaired cognition in schizophrenia and developing effective treatment for cognitive symptoms are major unmet challenges for contemporary biomedical research. Briefly, deficits in speed of processing have been correlated with a reduced temporal lobe volume and increased ventricular size. Attention impairments were correlated with structural alterations within the frontal and temporal lobes and with widespread reduced volume of subcortical regions . Decreased working memory was correlated with reduced frontal and temporal lobe volumes and cortical thickness while language and memory deficits were correlated with hippocampal volume loss. Impaired visuspatial and memory correlated with hippocampal volume loss. Deficits in reasoning and problem solving, including higher-order executive functions, were also associated with a reduced the dorsolateral prefrontal cortex volume. Among different neuroimaging modalities, functional magnetic resonance imaging (fMRI) predominates in system-level connectomic studies. Particularly, the task-free version-known as resting fMRI-is better tolerated by clinical populations, and circumvents the need for stringent subject compliance. Today, fMRI features are being rigorously examined to identify potential biomarkers for diagnosis and prognosis of different brain disorders

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

twenty subjects will be chosen from psychiatric inpatient unit from assiut university hospitals diagnosed with schizophrenia and 20 subjects as control to be investigated for affection of brain activity in case of schizophrenia

Description

Inclusion Criteria:

  • Diagnosis according to Diagnostic and statistical manual of mental of mental disorders -5 (DSM-5) and confirmed by the Structured Clinical Interview for DSM-5 (SCID -I)

Exclusion Criteria:

  • History of head injury.
  • History of intellectual disability or neurological diseases e.g. cerebrovascular stroke, dementia Parkinsonism, etc.
  • History of alcohol and/or substance abuse in the previous six months.
  • Inability to provide informed consent.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group A Patients
Schizophrenic patients according to diagnostic criteria
Device: Functional MRI
Functional Magnetic Resonance Imaging during rest for minutes and analysis of data obtained from resting fMRI
group B Control
healthy subjects not suffering from any Psychiatric illness
Device: Functional MRI
Functional Magnetic Resonance Imaging during rest for minutes and analysis of data obtained from resting fMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional Magnetic Resonance Imaging
Time Frame: baseline
different regional brain activity among schizophrenic and healthy subjects and correlation with cognitive function
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Wageeh A Hassan, MD, Assiut University
  • Study Director: Hossam E Khalifa, Assiut University

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 (Estimated)

October 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

June 18, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fMRI in schizophrenia

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.

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