Neural Correlates of Social Touch and Interoceptive Perception as Potential Biomarker for Impaired Social Functioning

Schizophrenia Clinical Trial

— SPIRIT  

Official title:

Neural Correlates of Social Touch and Interoceptive Perception as Potential Biomarker for Impaired Social Functioning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04968223
• Other study ID #: SPIRIT
• Status: Recruiting
• Start date: August 16, 2021
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: University of Oldenburg
• Contact: René Hurlemann, Prof.
• Phone: +49 (0)441 9615
• Email: rene.hurlemann[@]uni-oldenburg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Recent studies have shown that certain biomarkers of schizophrenia could help to better assess the individual course of the disease and thus, contribute to more personalized treatment options. The aim of the SPIRIT study is to identify potential biomarkers for the prediction of disease-associated outcomes by investigating the neurobiological mechanisms of underlying schizophrenia-related dysfunctions.

Description:

Alterations in psychosocial functioning are evident from the prodromal phase of schizophrenia and play a crucial role in its chronic course. While recent studies have demonstrated the predictive validity of structural changes in the brain anatomy of patients with schizophrenia, there is a lack of studies assessing the predictive value of disease-associated alterations in the functional brain activity for symptom severity and psychosocial functioning in schizophrenia. In this longitudinal, observational study, 60 patients with schizophrenia and 40 healthy subjects without family history of psychotic illness will be recruited to investigate differences in behavioural, physiological, and neural correlates of social touch and interoceptive perception between participant groups. Participants' symptom severity and psychosocial functioning level will be examined by a wide range of behavioural, physiological, and neural methods. Potential biomarkers will be identified by estimating the predictive value of initially performed methods on follow-up re-examination of clinical and psychosocial outcomes. Neural readouts include structural and functional magnetic resonance imaging (fMRI) measurements. The fMRI tasks will probe the processing of social touch and interoceptive perception; additionally resting-state connectivity will be assessed. To further investigate pathological distortions of social touch and interoceptive perception, bodily touch allowance maps will be measured and participants will perform a heart-beat discrimination task. Psychometric questionnaires and semi-structured interviews will be used to capture symptom load and level of psychosocial functioning. Long-term effects will be assessed by online questionnaires and semi-structured interviews via phone call 3- and 6 months after initial assessments. The investigators hypothesize that differences in the neural response to social touch as well as in the neural patterns of interoceptive perception could serve as potential biomarkers for psychosocial deficits during the course of the illness. Furthermore, the inclusion of those biomarkers in predictive models could improve the prediction of disease progression and thus, contribute to personalized therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participant is able to provide consent.
• Diagnosis of schizophrenia or schizoaffective disorder according to DSM-V
• Control group: No psychiatric or neurological illness.
• Fluent in German.

Exclusion Criteria:

• The participant does not fulfill requirements for MRI measurements according to safety guidelines.
• Acute suicidality.
• Current substance dependence.
• A history of head trauma or neurological illness.

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
Germany	Department of Psychiatry, University of Oldenburg	Bad Zwischenahn

Sponsors (2)

Lead Sponsor	Collaborator
University of Oldenburg	Danilo Postin, M.Sc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neural responses in a social touch task	Participants will be measured with functional magnetic resonance imaging (fMRI) while they perceive different types of social and non-social touch	One-time baseline assessment
Primary	Behavioral responses in a social touch fMRI task	Measured as behavioral ratings during the social touch fMRI task. During the social touch fMRI task, participants rate the comfort of the tactile stimuli on a visual analogue scale.	One-time baseline assessment
Primary	Neural responses in an interoception fMRI task	Participants will be measured with functional magnetic resonance imaging (fMRI) while they perform an interoception task	One-time baseline assessment
Primary	Behavioral responses in an interoception fMRI task	Measured by performance on the interoception task. During the interoception fMRI task, participants rate how intensely they perceived their heartbeat or their stomach on a visual analogue scale.	One-time baseline assessment
Primary	Changes in clinician-rated symptom severity between baseline and follow-ups	Measured by half-structured interviews (e.g. Positive and Negative Syndrome Scale (PANSS); range: 30-210; higher scores indicating more severe symptoms) for disease-related symptoms	Baseline, 3 and 6 months follow- up after initial baseline assessment
Primary	Changes in self-reported symptom severity between baseline and follow-ups	Measured by self-evaluation questionnaires (e.g. Self-assessment of Negative Symptoms (SNS); range 1-20; higher scores indicating more severe symptoms) for disease-related symptoms	Baseline, 3 and 6 months follow- up after initial baseline assessment
Primary	Changes in clinician-rated social-role functioning between baseline and follow-ups	Measured by the clinician-rated the social-role functioning scale (range: 1-10; higher scores indicating higher functioning)	Baseline, 3 and 6 months follow- up after initial baseline assessment
Primary	Changes in self-reported social-role functioning levels between baseline and follow-ups	Measured by the self-evaluation questionnaires for social-role functioning (e.g. Social Network Index (SNI); range 1-12; higher scores indicating higher functioning)	Baseline, 3 and 6 months follow-up after initial baseline assessment
Secondary	Bodily maps of social touch	Measured as performance on a bodily maps computer task	One-time baseline assessment
Secondary	Attitude towards social touch	Measured by the self-evaluation questionnaire for social touch tolerance (e.g. Social Touch Questionnaire; range 0-4; higher scores indicating higher touch tolerance)	One-time baseline assessment
Secondary	Interoceptive accuracy	Measured as performance on a heartbeat discrimination task	One-time baseline assessment
Secondary	Interoceptive awareness	Measured by a self-evaluation questionnaire for interoceptive awareness (e.g. Multidimensional Assessment of Interoceptive Awareness (MAIA); range 0-5; higher scores indicating higher interoceptive awareness)	One-time baseline assessment
Secondary	Blood parameter	Measured by schizophrenia related, Nuclear Magnetic Resonance spectroscopy (NMR) based metabolomics	One-time baseline assessment
Secondary	Urine parameter	Measured by schizophrenia related, Nuclear Magnetic Resonance spectroscopy (NMR) based metabolomics	One-time baseline assessment
Secondary	Neural activity at resting state	fMRI will be performed to measure BOLD-signal while participants lay in the MRI-scanner with eyes open.	One-time baseline assessment
Secondary	Structural connectivity measure	fMRI will be performed to measure BOLD-signal while participants lay in the MRI-scanner with eyes open.	One-time baseline assessment