NCT06978803

Brief Summary

This multimodal study explores the mechanisms underlying social dysfunction in individuals with schizophrenia. It focuses on the relationship between disorganized communication and social interaction, aiming to identify measurable markers of disorganized communication and link them to clinical symptoms and social functioning. Key Research Questions: How do neural and behavioural synchrony contribute to social impairments in schizophrenia? What roles do interbrain synchrony, motor imitation, reaction time, and verbal coherence play in disorganized communication? Participants will:

  1. 1.Engage in structured and semi-structured real-time social interactions while undergoing dual-brain electroencephalogram (EEG) hyperscanning to measure neural and behavioural activity.
  2. 2.Perform nonverbal tasks such as motor imitation and reaction time assessments to investigate coordination and behavioural synchrony patterns.
  3. 3.Participate in a clinical interview that evaluates verbal production, thought coherence, and speech organization.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress78%
Jan 2024Dec 2026

Study Start

First participant enrolled

January 16, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 18, 2025

Status Verified

November 1, 2024

Enrollment Period

1.8 years

First QC Date

January 13, 2025

Last Update Submit

May 11, 2025

Conditions

Keywords

hyperscanning eegpsychosisimitation tasksinterbrain synchronymotor imitationmotor behaviourspeech disorganizationnatural language processing

Outcome Measures

Primary Outcomes (1)

  • Inter-brain phase synchronization using Phase Locking Index via hyperscanning during communication

    Using oscillatory and time-frequency analyses of electroencephalography (EEG) hyperscanning data, inter-brain synchronization will be calculated via phase locking value for both patients and control subjects. This value will be related to: (1) verbal data from clinical interviews analyzed using Natural Language Processing techniques, including sentiment analysis to assess emotional tone, coherence classification to evaluate logical flow, and semantic similarity analysis (2) nonverbal measures such as motor synchrony, imitation accuracy, and reaction time.

    baseline

Other Outcomes (1)

  • Composite Index of Severity as Measured by the Positive and Negative Syndrome Scale (PANSS), THought and Language Index and Social and Occupational Functioning (SOFAS)

    baseline

Study Arms (2)

Healthy controls

1. English or French-speaking participants (as dyads matched for language preference). 2. Ages 18-60 years. 3. No diagnosis of schizophrenia or schizoaffective illness based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria.

Patients

1. English or French-speaking participants (as dyads matched for language preference). 2. Ages 18-60 years. 3. Patients meeting the operational criteria for schizophrenia or schizoaffective illness as previously diagnosed by their treating psychiatrist, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria. 4. Patients with less than 5 years of illness onset, based on the time of starting treatment with antipsychotic medication.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with psychosis will be recruited from the following Douglas Mental Health University Institute areas: l'Étape Outpatient Clinic, Assertive Community Treatment Clinics, Intensive Psychosocial Rehab Clinic, and the Prevention and Early Intervention Program for Psychosis (PEPP) clinics in CIUSSS de l'ouest-de-L'île-de-Montréal, in association with the Centre for Youth Mental Health at the Douglas. Healthy Control participants will be recruited from the Greater Montreal Area using online study advertisements (Facebook, Kijiji, Twitter) and research study posters placed on bulletin boards.

You may qualify if:

  • English or French-speaking participants (as dyads matched for language preference).
  • Ages 18-60 years.
  • Patients meeting the operational criteria for schizophrenia or schizoaffective illness as previously diagnosed by their treating psychiatrist, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria (Zipursky et al., 2020).
  • Patients with less than 5 years of illness onset, based on the time of starting treatment with antipsychotic medication.

You may not qualify if:

  • Participants should not have a severe medical disorder that would explain psychotic symptoms.
  • Participants should not have a past or current history of a primary neurological disorder that can affect speech output
  • Participants with IQ below 70 or a concurrent pervasive developmental disorder (e.g., autism) will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

RECRUITING

Related Publications (28)

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    PMID: 23999082BACKGROUND
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    PMID: 38770754BACKGROUND
  • Liu T, Pelowski M. Clarifying the interaction types in two-person neuroscience research. Front Hum Neurosci. 2014 Apr 30;8:276. doi: 10.3389/fnhum.2014.00276. eCollection 2014. No abstract available.

    PMID: 24817848BACKGROUND
  • Nowak A, Vallacher RR, Zochowski M, Rychwalska A. Functional Synchronization: The Emergence of Coordinated Activity in Human Systems. Front Psychol. 2017 Jun 13;8:945. doi: 10.3389/fpsyg.2017.00945. eCollection 2017.

    PMID: 28659842BACKGROUND
  • Koul A, Ahmar D, Iannetti GD, Novembre G. Interpersonal synchronization of spontaneously generated body movements. iScience. 2023 Feb 1;26(3):106104. doi: 10.1016/j.isci.2023.106104. eCollection 2023 Mar 17.

    PMID: 36852275BACKGROUND
  • Bolis D, Dumas G, Schilbach L. Interpersonal attunement in social interactions: from collective psychophysiology to inter-personalized psychiatry and beyond. Philos Trans R Soc Lond B Biol Sci. 2023 Feb 13;378(1870):20210365. doi: 10.1098/rstb.2021.0365. Epub 2022 Dec 26.

    PMID: 36571122BACKGROUND
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    PMID: 28637195BACKGROUND
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Related Links

MeSH Terms

Conditions

Psychotic DisordersSchizophreniaMotor Activity

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavior

Study Officials

  • Lena Palaniyappan, MD, PhD

    Douglas Mental Health University Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel Olarewaju, PhD Candidate

CONTACT

Lena Palaniyappan, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

January 13, 2025

First Posted

May 18, 2025

Study Start

January 16, 2024

Primary Completion

October 22, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

May 18, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

We propose to use a clinical linguistic archiving system called the TalkBank (https://www.talkbank.org/) for data sharing purposes. TalkBank registry/database is located at Carnegie Mellon University, Pittsburgh, Pennsylvania-USA. Several filters are used to de-identify the recorded speech data before storage in the databank. Firstly, the Discourse protocol explicitly avoids using proper nouns and names/addresses. Second, the transcribed data is checked, and any proper names are replaced by common names (e.g., 'McGill' will be changed to 'University') or bleeped out (for audio data). If requested, we will play back the recorded responses to check if the participant is comfortable with the degree of anonymity. Identifying demodemographics will not be stored alongside the speech data to reduce triangulation. Finally, sharing is controlled by password protection, and a re-review is done to remove identifying information before sharing is initiated.

Shared Documents
STUDY PROTOCOL
Time Frame
December 2028 for an unlimitied amount of time. There are no plans for data destruction of the study information stored (de-identified audio and transcriptions) within TalkBank.
Access Criteria
The anonymized speech data will be retained on an access-controlled secure database hosted by TalkBank. We anticipate this being available within 2 years of the enrolment of the last participant. For more information see https://psychosis.talkbank.org/ and https://discourseinpsychosis.org/

Locations