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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04968223
Acronym
SPIRIT
Enrollment
106
Registered
2021-07-20
Start date
2021-08-16
Completion date
2024-11-30
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Biomarker-based prediction, Precision Psychiatry, Schizophrenia, Social functioning, Social Touch, Interoception, fMRI

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

Danilo Postin, M.Sc.
CollaboratorUNKNOWN
University of Oldenburg
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in self-reported social-role functioning levels between baseline and follow-upsBaseline, 3 and 6 months follow-up after initial baseline assessmentMeasured by the self-evaluation questionnaires for social-role functioning (e.g. Social Network Index (SNI); range 1-12; higher scores indicating higher functioning)
Neural responses in a social touch taskOne-time baseline assessmentParticipants will be measured with functional magnetic resonance imaging (fMRI) while they perceive different types of social and non-social touch
Behavioral responses in a social touch fMRI taskOne-time baseline assessmentMeasured 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.
Neural responses in an interoception fMRI taskOne-time baseline assessmentParticipants will be measured with functional magnetic resonance imaging (fMRI) while they perform an interoception task
Behavioral responses in an interoception fMRI taskOne-time baseline assessmentMeasured 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.
Changes in clinician-rated symptom severity between baseline and follow-upsBaseline, 3 and 6 months follow- up after initial baseline assessmentMeasured 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
Changes in self-reported symptom severity between baseline and follow-upsBaseline, 3 and 6 months follow- up after initial baseline assessmentMeasured 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
Changes in clinician-rated social-role functioning between baseline and follow-upsBaseline, 3 and 6 months follow- up after initial baseline assessmentMeasured by the clinician-rated the social-role functioning scale (range: 1-10; higher scores indicating higher functioning)

Secondary

MeasureTime frameDescription
Bodily maps of social touchOne-time baseline assessmentMeasured as performance on a bodily maps computer task
Attitude towards social touchOne-time baseline assessmentMeasured by the self-evaluation questionnaire for social touch tolerance (e.g. Social Touch Questionnaire; range 0-4; higher scores indicating higher touch tolerance)
Interoceptive accuracyOne-time baseline assessmentMeasured as performance on a heartbeat discrimination task
Interoceptive awarenessOne-time baseline assessmentMeasured 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)
Blood parameterOne-time baseline assessmentMeasured by schizophrenia related, Nuclear Magnetic Resonance spectroscopy (NMR) based metabolomics
Urine parameterOne-time baseline assessmentMeasured by schizophrenia related, Nuclear Magnetic Resonance spectroscopy (NMR) based metabolomics
Neural activity at resting stateOne-time baseline assessmentfMRI will be performed to measure BOLD-signal while participants lay in the MRI-scanner with eyes open.
Structural connectivity measureOne-time baseline assessmentfMRI will be performed to measure BOLD-signal while participants lay in the MRI-scanner with eyes open.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026