Magnetoencephalography in Psychosis Program

NCT06978881 | Enrolling By Invitation

• 1 other identifier: 2024-925
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This research involves the examination of speech, thinking patterns and symptoms and recordings from brain's activity in patients with schizophrenia. The reserchers are investigating if the electrical waves (recorded indirectly using the resulting magnetic field around our head) are disrupted in psychosis, especially in the language related problems seen in this disorder. To examine language, participants will be asked to complete a speech tasks using the DISCOURSE speech elicitation script in which they will be requested to share their thoughts. For this purpose, the participants will be shown some pictures and asked to describe what they see, discuss a significant event from their life and tell a story in their own words. The description of the pictures and other responses to the tasks will be audio-recorded for later transcription into a written format. The researches will examine the brain regions using Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI). MEG and MRI are both non-invasive functional brain imaging technologies. MRI collects structural information and creates images of the brain while MEG collects magnetic activity from neurons, visualized as brain waves. The MRI machine uses a large magnet to help create images while MEG captures the fluctuations in the small magnetic fields resulting from brain's activity. Participants will also undergo a clinical and neurocognitive assessments. This project design involves 50 individuals who will take part in the study; 25 affected and 25 healthy volunteers aged 18 to 50 years.

Conditions

Schizophrenia Disorders; Psychosis

Keywords

Magnetoencephalography; MEG; temporal regularity; Language disorders; neural activity; natural language processing; disorganization; impoverishment; formal thought disorder

Outcome Measures

Primary Outcomes (1)

• Beta-band Oscillatory Power derived from Magnetoencephalography

  The measurement of beta-band oscillatory activity in response to a motor task to assess neurophysiological abnormalities in the temporal regularity of neural activity within the beta-band frequency. These measurements will be obtained using magnetoencephalography (MEG), which captures the oscillatory patterns of brain activity. The focus will be on how these patterns deviate in patients with schizophrenia compared to healthy controls. The primary outcome will assess beta-band power in relation to disorganization in speech.

  baseline

Other Outcomes (4)

• Language Model Based Measure of Disorganization

  baseline

• Functional Connectivity using Magnetoencephalography

  baseline

• Functional Connectivity using resting state functional MRI

  baseline

Study Arms (2)

Healthy controls

25 healthy volunteers; (1)English or French speeking, (2) Aged 18 to 50 years (group-matched with the patients for age (within 2 years), sex and parental occupational status, rated according to the National Statistics Socio-Economic Classification), (3) No personal or family history of psychotic disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria, (4) No history of head trauma, major neurological disorder (e.g., epilepsy) or somatic disorder with neurological complaints (e.g., multiple sclerosis), or intellectual disabilities, (5) No diagnosis of substance use disorder - current or in the preceding 1 year as defined by DSM 5, (6) suitable to undergo MRI scan, as per the safety screening questionnaire (not having metal in the body, not being pregnant or suffering from tinnitus).

Patients

(1) English or French-speaking, (2) Aged 18-50 years, (3) Patients meeting the DSM 5 criteria for schizophrenia as previously diagnosed by their treating psychiatrist, (4) Patients in a stable phase of the illness (defined as having had no change in Global Functioning of greater than 10 units out of a total range of 100 units for 1 month before the MEG scan), assessed using the Global Assessment of Functioning Scale (Endicott et al, 1976) in the 4 weeks preceding the study, (5) Patients with no diagnosis of substance use disorder - current or in the preceding 1 year as defined by DSM 5 criteria, (6) Patients suitable to undergo MRI scan, as per the safety screening questionnaire (having no metal in the body, not being pregnant or suffering from tinnitus).

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from 3 institutions; 1. Douglas Mental Health University Institute 2. Lakeshore General Hospital and 3. McGill University Health Centre. Initial contact and information about this study will be communicated by clinicians who are members of the patient's mental health care team at these locations. Healthy Control participants will be recruited from the Greater Montreal Area using online study advertisements and research study posters placed on bulletin boards at the three Mental Health Institutions

You may qualify if:

• Clinical diagnosis of schizophrenia as per DSM-5 criteria.
• Aged between 18 and 50 years.
• In a stable phase of the illness (no change in Global Functioning \> 10 units within 1 month before the MEG scan assessed using the Global Assessment of Functioning Scale).

You may not qualify if:

• Inability to speak English or French.
• History of head trauma, major neurological disorders (e.g., epilepsy), somatic disorders with neurological complaints (e.g., multiple sclerosis), or intellectual disabilities.
• Diagnosis of substance use disorder (current or within the last year) as per DSM-5.
• Unsuitable for MRI due to safety concerns (e.g., metal in the body, pregnancy, tinnitus).
• Healthy Controls
• Healthy volunteers aged between 18 and 50 years.
• Matched to patients for age (within 2 years), sex, and parental occupational status (rated by NS-SEC).
• Inability to speak English or French.
• History of head trauma, major neurological disorders (e.g., epilepsy), somatic disorders with neurological complaints (e.g., multiple sclerosis), or intellectual disabilities.
• Diagnosis of substance use disorder (current or within the last year) as per DSM-5.
• Personal or family history of psychotic disorder.
• Unsuitable for MRI due to safety concerns (e.g., metal in the body, pregnancy, tinnitus).

Sponsors & Collaborators

• Douglas Mental Health University Institute: lead

Study Sites (1)

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

Location

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Language Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lena Palaniyappan, MD, PhD

  Douglas Mental Health University Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Centre of Excellence in Youth Mental Health

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: May 18, 2025
• Study Start: May 8, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available after all of the intended recruitment and the curation of data is completed. This will be no later than 2 years after the date of the last recruited subject. There are no plans for data destruction of the study information stored (de-identified audio and transcriptions) within TalkBank.
• Access Criteria: Access to the speechbank database will be password protected and restricted to scientific members of an international consortium of researchers who collaborate on this effort (the DISCOURSE group)

Locations

CA (1)