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En omfattende vurdering av endret utførelse hos personer med ryggmargsskade (SCI_Embodiment)

9. november 2026 oppdatert av: 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).

Studieoversikt

Studietype

Observasjonsmessig

Registrering (Faktiske)

80

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: CASE_CONTROL
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. juni 2025

Primær fullføring (Faktiske)

30. juli 2026

Studiet fullført (Faktiske)

31. juli 2026

Datoer for studieregistrering

Først innsendt

12. november 2024

Først innsendt som oppfylte QC-kriteriene

12. november 2024

Først lagt ut (Faktiske)

14. november 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. november 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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