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Completed

NCT Number: NCT04968223

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Psychiatry, University of Oldenburg

Bad Zwischenahn, 26160, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Neural responses in a social touch task

    Time frame: One-time baseline assessment

    Participants will be measured with functional magnetic resonance imaging (fMRI) while they perceive different types of social and non-social touch

  2. Behavioral responses in a social touch fMRI task

    Time frame: One-time baseline assessment

    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.

  3. Neural responses in an interoception fMRI task

    Time frame: One-time baseline assessment

    Participants will be measured with functional magnetic resonance imaging (fMRI) while they perform an interoception task

  4. Behavioral responses in an interoception fMRI task

    Time frame: One-time baseline assessment

    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.

  5. Changes in clinician-rated symptom severity between baseline and follow-ups

    Time frame: Baseline, 3 and 6 months follow- up after initial baseline assessment

    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

  6. Changes in self-reported symptom severity between baseline and follow-ups

    Time frame: Baseline, 3 and 6 months follow- up after initial baseline assessment

    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

  7. Changes in clinician-rated social-role functioning between baseline and follow-ups

    Time frame: Baseline, 3 and 6 months follow- up after initial baseline assessment

    Measured by the clinician-rated the social-role functioning scale (range: 1-10; higher scores indicating higher functioning)

  8. Changes in self-reported social-role functioning levels between baseline and follow-ups

    Time frame: Baseline, 3 and 6 months follow-up after initial baseline assessment

    Measured by the self-evaluation questionnaires for social-role functioning (e.g. Social Network Index (SNI); range 1-12; higher scores indicating higher functioning)

Secondary outcomes

  1. Bodily maps of social touch

    Time frame: One-time baseline assessment

    Measured as performance on a bodily maps computer task

  2. Attitude towards social touch

    Time frame: One-time baseline assessment

    Measured by the self-evaluation questionnaire for social touch tolerance (e.g. Social Touch Questionnaire; range 0-4; higher scores indicating higher touch tolerance)

  3. Interoceptive accuracy

    Time frame: One-time baseline assessment

    Measured as performance on a heartbeat discrimination task

  4. Interoceptive awareness

    Time frame: One-time baseline assessment

    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)

  5. Blood parameter

    Time frame: One-time baseline assessment

    Measured by schizophrenia related, Nuclear Magnetic Resonance spectroscopy (NMR) based metabolomics

  6. Urine parameter

    Time frame: One-time baseline assessment

    Measured by schizophrenia related, Nuclear Magnetic Resonance spectroscopy (NMR) based metabolomics

  7. Neural activity at resting state

    Time frame: One-time baseline assessment

    fMRI will be performed to measure BOLD-signal while participants lay in the MRI-scanner with eyes open.

  8. Structural connectivity measure

    Time frame: One-time baseline assessment

    fMRI will be performed to measure BOLD-signal while participants lay in the MRI-scanner with eyes open.

Sponsors and collaborators

Lead sponsor

University of Oldenburg

Other

Collaborators

  • Danilo Postin, M.Sc.

Registry information

Acronym: SPIRIT

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 20, 2021
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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