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Une évaluation complète de l'incarnation altérée chez les personnes souffrant d'une lésion médullaire (SCI_Embodiment)

9 novembre 2026 mis à jour par: 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).

Aperçu de l'étude

Type d'étude

Observationnel

Inscription (Réel)

80

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

Individuals with spinal cord injury and healthy controls.

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: CASE_CONTROL
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Score on the Body Feelings and Illusions questionnaire (BoFI)
Délai: Baseline

A questionnaires that assess different dimensions of embodiment and disembodiment.

Baseline

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Brain activity
Délai: 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
Délai: Baseline

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

Baseline
Qualitative assessment of embodiment
Délai: 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)
Délai: Baseline

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

Baseline
Pain severity
Délai: Baseline

Intensity of pain measured on a visual analogue scale.

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

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

Baseline
Score on the Pittsburgh Sleep Quality Index
Délai: Baseline

A questionnaire assessing the quality of sleep.

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

A questionnaire assessing interoceptive awarness.

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

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

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

A scale assessing satisfaction in life.

Baseline
Motor symptoms severity
Délai: Baseline

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

Baseline
Demographics
Délai: Baseline

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

Baseline

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

4 juin 2025

Achèvement primaire (Réel)

30 juillet 2026

Achèvement de l'étude (Réel)

31 juillet 2026

Dates d'inscription aux études

Première soumission

12 novembre 2024

Première soumission répondant aux critères de contrôle qualité

12 novembre 2024

Première publication (Réel)

14 novembre 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 novembre 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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