SchizophreniaNCT06471179
Functional Magnetic Resonance Imaging Study in Schizophrenia Patients and Correlation With Cognitive Impairments
An observational study of Schizophrenia and Cognitive Impairment, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Cognitive Impairment
- What is being tested?
- Functional MRI
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Functional Magnetic Resonance Imaging Study of Schizophrenic Patients and Its Correlation With Cognitive Impairments
- 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.
- Correlation with resting functional activity at brain areas with clinical deterioration in cognitive functions.
Read the 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
- Conditions
- Schizophrenia, Cognitive Impairment
- Being tested
- Functional MRI
- Keywords
- Functional MRI, Schizophrenia
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional MRIDevice
Functional Magnetic Resonance Imaging during rest for minutes and analysis of data obtained from resting fMRI
| Study group | Role | What they receive |
|---|---|---|
| group A Patients | Schizophrenic patients according to diagnostic criteria Receives: Device: Functional MRI | |
| group B Control | healthy subjects not suffering from any Psychiatric illness Receives: Device: Functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional Magnetic Resonance Imaging
different regional brain activity among schizophrenic and healthy subjects and correlation with cognitive function
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, waleed ashraf hamdy ahmed, Assiut University
- Investigators
- Wageeh A Hassan, MD, Study chair, Assiut UniversityHossam E Khalifa, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471179
- Sponsor's protocol ID
- fMRI in schizophrenia
- Status last verified
- Jul 2024
- First submitted
- 18 Jun 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Magnetic Resonance Imaging Study of Schizophrenic Patients and Its Correlation With Cognitive Impairments
- ClinicalTrials.gov ID
- NCT06471179
- Acronym / sponsor ID
- fMRI in schizophrenia
- Conditions
- Schizophrenia, Cognitive Impairment
- Keywords
- Functional MRI, Schizophrenia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- Correlation with resting functional activity at brain areas with clinical deterioration in cognitive functions.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A Patients | – | Device: Functional MRISchizophrenic patients according to diagnostic criteria |
| group B Control | – | Device: Functional MRIhealthy subjects not suffering from any Psychiatric illness |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional MRIFunctional Magnetic Resonance Imaging during rest for minutes and analysis of data obtained from resting fMRI | Device | group A Patients, group B Control |
Primary outcome
functional Magnetic Resonance Imaging
Time frame: baseline
different regional brain activity among schizophrenic and healthy subjects and correlation with cognitive function
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wageeh A Hassan, MD study chair
Assiut University
Hossam E Khalifa study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Cognitive Impairment, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact waleed A Hamdy (01030968160, waleedashraf7@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional Magnetic Resonance Imaging (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.