SchizophreniaecovalNCT03543553
From Brain Currents to Interpersonal Flow: Investigating the Social Processing Stream of Schizophrenia
An observational study of Schizophrenia and Cognitive Impairment, run by Oslo University Hospital.
Trial summary
The overall objective of this project is to identify the neural signature of the impaired ability to relate socially seen in individuals with schizophrenia. A hypothesized path from the neural processes of social cognition, to social cognition assessed behaviorally, to real-life social interactions is examined. Read more about this study
- Who is it for?
- Ages 17 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Cognitive Impairment, Social Competence
- What is being tested?
- This is not an intervention study
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Mar 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 17 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Individuals with a diagnosis of schizophrenia will be compared to healthy control participants
Who may be able to join
- schizophrenia
- schizoaffective disorder
Who cannot join
- diabetes
- Hyperthyroidism
- severe head trauma
- neurological disease
About this study
The overall objective of this project is to identify the neural signature of the impaired ability to relate socially seen in individuals with schizophrenia. A hypothesized path from the neural processes of social cognition, to social cognition assessed behaviorally, to real-life social interactions is examined. Secondary aims are to compare electrophysiological measures of high vs low level social cognition; to develop assessment methods of real-life behavior; and to increase the ecological validity of schizophrenia research. Much research within the field is devoid of personal meaning and interpersonal context. This project's use of personalized assessment allows for an ecologically valid approach to the social deficits of schizophrenia.
- Conditions
- Schizophrenia, Cognitive Impairment, Social Competence
- Being tested
- This is not an intervention study
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is not an intervention studyOther
This is not an intervention study
| Study group | Role | What they receive |
|---|---|---|
| SZ | Individuals with a diagnosis of schizophrenia Receives: Other: This is not an intervention study | |
| HC | Healthy control participants Receives: Other: This is not an intervention study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurophysiology: EEG
EEG mu suppression paradigm using point-light displays
Measured: 1 day (when assessed)
Neurophysiology: ERP
ERP mentalizing paradigm (perspective taking)
Measured: 1 day (when assessed)
Cognition
Matrics Consensus Cognitive Battery
Measured: 1 day (when assessed)
Negative symptoms: clinician-rated
Positive and Negative Syndrome Scale (PANSS) 2. Objectively assessed using computerized software (FaceReader, PRAAT) of video-taped personal narratives produced by the participants
Measured: 1 day (when assessed)
Negative symptoms: objective 1
FaceReader
Measured: 1 day (when assessed)
Negative symptoms: objective 2
PRAAT
Measured: 1 day (when assessed)
Social cognition: complex ToM
Movie for the Assessment of Social Cognition
Measured: 1 day (when assessed)
Social cognition: low level ToM
The Hinting Task
Measured: 1 day (when assessed)
Social cognition: facial emotion perception
Pictures of Facial Affect
Measured: 1 day (when assessed)
Social cognition: body language reading
Emotion in Biological Motion test
Measured: 1 day (when assessed)
Functioning
Social Functioning Scale (SFS). Seven scales that can be combined into a total score. Mean score in a schizophrenia population = 100, SD = 15. For both the seven scales and the total score.
Measured: 1 day (when assessed)
Real-world behaviour
Day Reconstruction Method
Measured: 1 day (when assessed)
Real-world social interactions
Video-ethnography
Measured: 1 day (when assessed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start1 Jan 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 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 Oslo University HospitalThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anja Vaskinn, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543553
- Sponsor's protocol ID
- ecoval
- Acronym
- ecoval
- Status last verified
- Nov 2023
- First submitted
- 17 Apr 2018
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Brain Currents to Interpersonal Flow: Investigating the Social Processing Stream of Schizophrenia
- ClinicalTrials.gov ID
- NCT03543553
- Acronym / sponsor ID
- ecoval / ecoval
- Conditions
- Schizophrenia, Cognitive Impairment, Social Competence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 1 Jun 2018 (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.
The overall objective of this project is to identify the neural signature of the impaired ability to relate socially seen in individuals with schizophrenia. A hypothesized path from the neural processes of social cognition, to social cognition assessed behaviorally, to real-life social interactions is examined. Secondary aims are to compare electrophysiological measures of high vs low level social cognition; to develop assessment methods of real-life behavior; and to increase the ecological validity of schizophrenia research. Much research within the field is devoid of personal meaning and interpersonal context. This project's use of personalized assessment allows for an ecologically valid approach to the social deficits of schizophrenia.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SZ | – | Other: This is not an intervention studyIndividuals with a diagnosis of schizophrenia |
| HC | – | Other: This is not an intervention studyHealthy control participants |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Individuals with a diagnosis of schizophrenia will be compared to healthy control participants
Key inclusion criteria (2 listed)
- schizophrenia
- schizoaffective disorder
Key exclusion criteria (4 listed)
- diabetes
- Hyperthyroidism
- severe head trauma
- neurological disease
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 |
|---|---|---|
| This is not an intervention studyThis is not an intervention study | Other | HC, SZ |
Primary outcome
Neurophysiology: EEG
Time frame: 1 day (when assessed)
EEG mu suppression paradigm using point-light displays
Neurophysiology: ERP
Time frame: 1 day (when assessed)
ERP mentalizing paradigm (perspective taking)
Cognition
Time frame: 1 day (when assessed)
Matrics Consensus Cognitive Battery
Negative symptoms: clinician-rated
Time frame: 1 day (when assessed)
Positive and Negative Syndrome Scale (PANSS) 2. Objectively assessed using computerized software (FaceReader, PRAAT) of video-taped personal narratives produced by the participants
Negative symptoms: objective 1
Time frame: 1 day (when assessed)
FaceReader
Negative symptoms: objective 2
Time frame: 1 day (when assessed)
PRAAT
Social cognition: complex ToM
Time frame: 1 day (when assessed)
Movie for the Assessment of Social Cognition
Social cognition: low level ToM
Time frame: 1 day (when assessed)
The Hinting Task
Social cognition: facial emotion perception
Time frame: 1 day (when assessed)
Pictures of Facial Affect
Social cognition: body language reading
Time frame: 1 day (when assessed)
Emotion in Biological Motion test
Functioning
Time frame: 1 day (when assessed)
Social Functioning Scale (SFS). Seven scales that can be combined into a total score. Mean score in a schizophrenia population = 100, SD = 15. For both the seven scales and the total score.
Real-world behaviour
Time frame: 1 day (when assessed)
Day Reconstruction Method
Real-world social interactions
Time frame: 1 day (when assessed)
Video-ethnography
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 28 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Cognitive Impairment, run by Oslo University Hospital.
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 2 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 28 Nov 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurophysiology: EEG (time frame: 1 day (when assessed)). The study lists 13 primary outcomes in all. 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 28 Nov 2023.