Clinical trial NCT04968223: Neural Correlates of Social Touch and Interoceptive Perception As Potential Biomarker for Impaired Social Functioning
Official title: Neural Correlates of Social Touch and Interoceptive Perception As Potential Biomarker for Impaired Social Functioning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Biomarker-based prediction
Precision Psychiatry
Schizophrenia
Social functioning
Social Touch
Interoception
fMRI
Lead sponsor: University of Oldenburg
Sponsor class: OTHER
Collaborators: name: Danilo Postin, M.Sc.
First posted: 2021-07-20
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In- and outpatients of the Department of Psychiatry, University of Oldenburg. Patients meeting the criteria for schizophrenia or schizoaffective disorder according to DSM-V will be included in the study. The patients' diagnosis will be verified via the structured clinical interview for DSM-V. Healthy subjects without family history of psychotic illness (control group). Control group will be matched to the patient sample.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Neural responses in a social touch task
timeFrame: One-time baseline assessment
measure: Behavioral responses in a social touch fMRI task
timeFrame: One-time baseline assessment
measure: Neural responses in an interoception fMRI task
timeFrame: One-time baseline assessment
measure: Behavioral responses in an interoception fMRI task
timeFrame: One-time baseline assessment
measure: Changes in clinician-rated symptom severity between baseline and follow-ups
timeFrame: Baseline, 3 and 6 months follow- up after initial baseline assessment
measure: Changes in self-reported symptom severity between baseline and follow-ups
timeFrame: Baseline, 3 and 6 months follow- up after initial baseline assessment
measure: Changes in clinician-rated social-role functioning between baseline and follow-ups
timeFrame: Baseline, 3 and 6 months follow- up after initial baseline assessment
measure: Changes in self-reported social-role functioning levels between baseline and follow-ups
timeFrame: Baseline, 3 and 6 months follow-up after initial baseline assessment
Secondary outcomes:
measure: Bodily maps of social touch
timeFrame: One-time baseline assessment
measure: Attitude towards social touch
timeFrame: One-time baseline assessment
measure: Interoceptive accuracy
timeFrame: One-time baseline assessment
measure: Interoceptive awareness
timeFrame: One-time baseline assessment
measure: Blood parameter
timeFrame: One-time baseline assessment
measure: Urine parameter
timeFrame: One-time baseline assessment
measure: Neural activity at resting state
timeFrame: One-time baseline assessment
measure: Structural connectivity measure
timeFrame: One-time baseline assessment
Other outcomes:
Locations:
city: Bad Zwischenahn
country: Germany
facility: Department of Psychiatry, University of Oldenburg
Study officials:
affiliation: Department of Psychiatry, University of Oldenburg
name: René Hurlemann, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychiatry, University of Oldenburg
name: Dirk Scheele, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychiatry, University of Oldenburg
name: Danilo Postin, M.Sc.
role: STUDY_DIRECTOR
References: