Value of Voxel-Based Morphometry in Schizophrenia

NCT07108673 | Not Yet Recruiting

• 1 other identifier: NCTMRISCHIZ2025
• Study Type: observational
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

This cross-sectional observational study investigates structural brain abnormalities in schizophrenia and nicotine use disorder (NUD), with a focus on understanding how these abnormalities correlate with behavioral traits such as decision-making and impulsivity. Schizophrenia is often associated with reduced gray matter (GM) in the prefrontal cortex and anterior cingulate cortex, while nicotine dependence is linked to changes in brain regions involved in reward processing. Nicotine use is particularly prevalent among individuals with schizophrenia, potentially compounding cognitive impairments. Voxel-Based Morphometry (VBM), an advanced neuroimaging analysis technique, allows for the detection of subtle structural changes in the brain using MRI data. This study aims to utilize VBM to explore GM alterations in three participant groups: Schizophrenic patients without nicotine dependence Schizophrenic patients with nicotine dependence Individuals with nicotine dependence but without schizophrenia Each group will include 32 participants, making a total sample of 96, calculated using G\*Power software assuming a medium effect size, alpha 0.05, and power 0.8. Inclusion criteria include confirmed diagnoses based on DSM-5 and the Fagerström Test for Nicotine Dependence, age 18-60, and MRI compatibility. Exclusion criteria involve other psychiatric or neurological disorders, substance use other than nicotine, and MRI contraindications. Participants will undergo: Structural MRI scans Behavioral assessment using the Barratt Impulsiveness Scale Clinical interviews using the Structured Clinical Interview for DSM-5 The primary outcome is to identify distinct patterns of GM reduction or alteration across groups, especially in regions involved in decision-making (e.g., prefrontal cortex, anterior cingulate cortex) and reward processing (e.g., ventral striatum). Secondary outcomes include correlating these structural findings with impulsivity and decision-making patterns. Statistical analysis will be performed using SPSS v26. ANOVA will be used for quantitative comparisons across the three groups, while Chi-square or Fisher's exact tests will compare categorical variables. Pearson's correlation will be used to explore associations between brain changes and behavioral traits. A p-value \<0.05 will be considered significant.

Conditions

Schizophrenia

Keywords

Voxel-Based Morphometry; Brain Structural Abnormalities; Schizophrenia; Nicotine use disorder

Outcome Measures

Primary Outcomes (1)

• structural abnormalities by MRI

  we will catch any structural abnormalities like GM reductions in the prefrontal cortex and anterior cingulate cortex

  at the enrollment

Secondary Outcomes (1)

• Behavioral testing

  at the enrollment

Study Arms (3)

Schizophrenic patients without nicotine dependence

Diagnostic Test: MRI

Schizophrenic patients with nicotine dependence

Diagnostic Test: MRI

Individuals with nicotine dependence but without schizophrenia

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

structural MRI imaging and behavioral testing (e.g. Barratt Impulsiveness scale) both performed by skilled physicians.

Individuals with nicotine dependence but without schizophrenia; Schizophrenic patients with nicotine dependence; Schizophrenic patients without nicotine dependence

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The targeted study groups are: Group 1: Schizophrenic patients without nicotine dependence. Group 2: Schizophrenic patients with nicotine dependence. Group 3: Nicotine use disorder individuals without schizophrenia. Each group will be matched for age, gender, and educational background to minimize potential confounding variables.

You may qualify if:

• Diagnosed schizophrenia (for groups 1 and 2).
• Nicotine dependence as defined by the Fagerström Test for Nicotine Dependence (for groups 2 and 3).
• Age range: 18-60 years.
• Schizophrenic patients must be stable on medications for at least 2 months.
• Written informed consent (from the patient or his carer).

You may not qualify if:

• History of other neurological or other psychiatric disorders (besides schizophrenia or nicotine dependence).
• Current substance use disorders other than nicotine.
• Severe head trauma or other conditions likely to affect brain structure.
• IQ below 70.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• Du X, Choa FS, Chiappelli J, Bruce H, Kvarta M, Summerfelt A, Ma Y, Regenold WT, Walton K, Wittenberg GF, Hare S, Gao S, van der Vaart A, Zhao Z, Chen S, Kochunov P, Hong LE. Combining neuroimaging and brain stimulation to test alternative causal pathways for nicotine addiction in schizophrenia. Brain Stimul. 2024 Mar-Apr;17(2):324-332. doi: 10.1016/j.brs.2024.02.020. Epub 2024 Mar 5.

  PMID: 38453003 BACKGROUND

• Wilke M, Kaufmann C, Grabner A, Putz B, Wetter TC, Auer DP. Gray matter-changes and correlates of disease severity in schizophrenia: a statistical parametric mapping study. Neuroimage. 2001 May;13(5):814-24. doi: 10.1006/nimg.2001.0751.

  PMID: 11304078 BACKGROUND

• Liu H, Guan L, Nie Y, Li Q, Xue J, Yang Y, Rong S, Liang J, Guan Y, Zhai F, Ren Y, An Z, Dong Z, Han Z. Brain Magnetic Resonance Imaging Features of Nicotine-Dependent Individuals and Its Correlation with Polymorphisms of Dopamine D Receptor Gene. Contrast Media Mol Imaging. 2022 Aug 24;2022:2296776. doi: 10.1155/2022/2296776. eCollection 2022.

  PMID: 36082055 BACKGROUND

• Brown GG, Lee JS, Strigo IA, Caligiuri MP, Meloy MJ, Lohr J. Voxel-based morphometry of patients with schizophrenia or bipolar I disorder: a matched control study. Psychiatry Res. 2011 Nov 30;194(2):149-56. doi: 10.1016/j.pscychresns.2011.05.005. Epub 2011 Sep 15.

  PMID: 21924872 BACKGROUND

• Segall JM, Turner JA, van Erp TG, White T, Bockholt HJ, Gollub RL, Ho BC, Magnotta V, Jung RE, McCarley RW, Schulz SC, Lauriello J, Clark VP, Voyvodic JT, Diaz MT, Calhoun VD. Voxel-based morphometric multisite collaborative study on schizophrenia. Schizophr Bull. 2009 Jan;35(1):82-95. doi: 10.1093/schbul/sbn150. Epub 2008 Nov 7.

  PMID: 18997157 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal investigator

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share