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En omfattende vurdering af ændret udførelsesform hos personer med rygmarvsskade (SCI_Embodiment)

9. november 2026 opdateret af: Swiss Paraplegic Research, Nottwil

Spinal cord injury (SCI) occurs when trauma or other factors damage the spinal cord, disrupting the flow of sensory information from the body to the brain. This interruption can interfere with embodiment-the body awareness and physical sensations processed by the brain-sometimes leading to a phenomenon called disembodiment.

For people with SCI, disembodiment may appear as unusual body sensations, like feeling that a limb is in a different position than it actually is. Such changes in body awareness can impact daily life, mental health, and rehabilitation outcomes.

Despite its importance, the study of embodiment in SCI remains limited. This project aims to explore how SCI alters embodiment, focusing on its specific characteristics, the effects on daily life, and the underlying brain activity as measured by functional magnetic resonance imaging (fMRI). Both people with and without SCI will participate.

Procedure: Participants will complete a single examination lasting 2 to 2.5 hours, including approximately 55 minutes in the MRI scanner (with preparation and follow-up).

Studieoversigt

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

80

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Canton of Lucerne
      • Nottwil, Canton of Lucerne, Schweiz, 6207
        • Swiss Paraplegic Research

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Individuals with spinal cord injury and healthy controls.

Beskrivelse

Inclusion Criteria for all participants:

  • Age between 18 and 60
  • Normal or corrected-to-normal visual acuity
  • German or Italian native speaker

Additional Inclusion Criteria only for individuals with SCI:

  • Diagnosis of traumatic spinal cord injury
  • Lesion level below T1 (first thoracic vertebra)
  • Time since injury >= 12 months
  • Residual sensation on the upper leg (sensory capability of 1 or higher on at least one leg in the dermatomes L2 and L3 for both light touch and pin prick).

Exclusion Criteria for all participants:

  • Pregnancy or breastfeeding
  • Diagnosis of other psychiatric or neurological disorders (e.g. epilepsy, tumor in the central nervous system)
  • Confirmed diagnosis of alcohol and/or drug abuse with active consumption within the last 6 months
  • Confirmed diagnosis of traumatic brain injury, intended as visible changes in the brain diagnosed by a radiologist
  • Stroke
  • Inability to perform study procedures (e.g. inability to consent)

Additional Exclusion Criteria for both HC and SCI undergoing the fMRI procedure:

  • Active medical devices (e.g. cardiac pacemaker)
  • Inability to perform study procedures (e.g. claustrophobia)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: CASE_CONTROL
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Individuals with SCI - Behavioral assessment

15 individuals with SCI will perform a comprehensive behavioral assessment of embodiment (see "Interventions"). A clinical assessment of sensory-motor symptoms will also be carried out.

A comprehensive behavioral assessment of embodiment and its effect on daily living, taking into account pain, interoception, emotions and anxiety, sleep quality, life satsfaction and cognition.

Individuals with SCI - Behavioral assessment and fMRI

25 individuals with SCI will perform a comprehensive behavioral assessment of embodiment and neural correlates of embodiment will be explored by means of an fMRI procedure (see "Interventions"). A clinical assessment of sensory-motor symptoms will also be carried out.

A comprehensive behavioral assessment of embodiment and its effect on daily living, taking into account pain, interoception, emotions and anxiety, sleep quality, life satsfaction and cognition.

Neural mechanisms of embodiments will be explored with MRI sequences including structural MRI, resting-state and task-based fMRI of the head.

The task will be a modified version of the rubber hand illusion, previously used to asess embodiment. Participants will be required to lay in the MRI with their legs bended upright and a screen placed at the level of their hips, which will show a pair of legs. The participant's leg will be stroked with a paintbrush while the image on the screen will be showing the virtual legs being stroked. Participants will be required to report how strongly they perceive the virtual legs as their own, as a measure of embodiment.

Healthy controls - Behavioral assessment

15 healthy controls will perform a comprehensive behavioral assessment of embodiment (see "Interventions").

A comprehensive behavioral assessment of embodiment and its effect on daily living, taking into account pain, interoception, emotions and anxiety, sleep quality, life satsfaction and cognition.

Healthy controls - Behavioral assessment and fMRI

25 individuals with SCI will perform a comprehensive behavioral assessment of embodiment and neural correlates of embodiment will be explored by means of an fMRI procedure (see "Interventions").

A comprehensive behavioral assessment of embodiment and its effect on daily living, taking into account pain, interoception, emotions and anxiety, sleep quality, life satsfaction and cognition.

Neural mechanisms of embodiments will be explored with MRI sequences including structural MRI, resting-state and task-based fMRI of the head.

The task will be a modified version of the rubber hand illusion, previously used to asess embodiment. Participants will be required to lay in the MRI with their legs bended upright and a screen placed at the level of their hips, which will show a pair of legs. The participant's leg will be stroked with a paintbrush while the image on the screen will be showing the virtual legs being stroked. Participants will be required to report how strongly they perceive the virtual legs as their own, as a measure of embodiment.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Score on the Body Feelings and Illusions questionnaire (BoFI)
Tidsramme: Baseline

A questionnaires that assess different dimensions of embodiment and disembodiment.

Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Brain activity
Tidsramme: Baseline

Brain activity defined as changes in oxygen levels in the blood during the execution of the embodiment task, and at rest.

Baseline
Strenght of the embodiment illusion
Tidsramme: Baseline

Strenght of the embodiment illusion during the fMRI procedures, measured through a Likert scale.

Baseline
Qualitative assessment of embodiment
Tidsramme: Baseline

Qualitative assessment of the experience of embodiment by means of a semi-structured interview.

Baseline
Score on the WHO Disability Assessment Scale (WHODAS-II)
Tidsramme: Baseline

A scale that assesses activity limitation and participation restriction in the daily life due to disability.

Baseline
Pain severity
Tidsramme: Baseline

Intensity of pain measured on a visual analogue scale.

Baseline
Score on the Positive and Negative Affect Schedule (PANAS)
Tidsramme: Baseline

A scale which measures positive and negative sensations over the course of the last week.

Baseline
Anxiety score on the Hospital Anxiety and Depression Scale (HADS)
Tidsramme: Baseline

A scale the assesses the presence and the intensity of anxiety and depressive symptoms.

Baseline
Depression score on the Hospital Anxiety and Depression Scale (HADS)
Tidsramme: Baseline

A scale the assesses the presence and the intensity of anxiety and depressive symptoms.

Baseline
Score on the Pittsburgh Sleep Quality Index
Tidsramme: Baseline

A questionnaire assessing the quality of sleep.

Baseline
Score on the Multidimensional Assessment of Interoceptive Awareness (MAIA)
Tidsramme: Baseline

A questionnaire assessing interoceptive awarness.

Baseline
Score on the Inclusion of Others in the Self test (IOS)
Tidsramme: Baseline

A questionnaire assessing the relationship of the individual self with other entities (e.g., the body, the famiy, the society).

Baseline
Score on the Montreal Cognitive Assessment (MoCA)
Tidsramme: Baseline

A test assessing cognitive functions such as memory, attention, language, and executive functions.

Baseline
Score on the Satisfaction with Life Scale (SLS)
Tidsramme: Baseline

A scale assessing satisfaction in life.

Baseline
Motor symptoms severity
Tidsramme: Baseline

Motor symptoms severity (from level A to E) based on the International Standards for Neurological Classification of spinal cord injury (ISNCSCI)

Baseline
Demographics
Tidsramme: Baseline

Demographic information such as age, sex and education level, as well as time since injury.

Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. juni 2025

Primær færdiggørelse (Faktiske)

30. juli 2026

Studieafslutning (Faktiske)

31. juli 2026

Datoer for studieregistrering

Først indsendt

12. november 2024

Først indsendt, der opfyldte QC-kriterier

12. november 2024

Først opslået (Faktiske)

14. november 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

The investigators plan to save anonymized data into public repositories. However, due to the size of the imaging data, a final decision has not yet been made.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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