Una evaluación integral de la alteración de la encarnación en personas con lesión de la médula espinal (SCI_Embodiment)
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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Canton of Lucerne
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Nottwil, Canton of Lucerne, Suiza, 6207
- Swiss Paraplegic Research
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Individuals with spinal cord injury and healthy controls.
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_CONTROL
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Score on the Body Feelings and Illusions questionnaire (BoFI)
Periodo de tiempo: Baseline
|
A questionnaires that assess different dimensions of embodiment and disembodiment. |
Baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Brain activity
Periodo de tiempo: Baseline
|
Brain activity defined as changes in oxygen levels in the blood during the execution of the embodiment task, and at rest. |
Baseline
|
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Strenght of the embodiment illusion
Periodo de tiempo: Baseline
|
Strenght of the embodiment illusion during the fMRI procedures, measured through a Likert scale. |
Baseline
|
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Qualitative assessment of embodiment
Periodo de tiempo: Baseline
|
Qualitative assessment of the experience of embodiment by means of a semi-structured interview. |
Baseline
|
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Score on the WHO Disability Assessment Scale (WHODAS-II)
Periodo de tiempo: Baseline
|
A scale that assesses activity limitation and participation restriction in the daily life due to disability. |
Baseline
|
|
Pain severity
Periodo de tiempo: Baseline
|
Intensity of pain measured on a visual analogue scale. |
Baseline
|
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Score on the Positive and Negative Affect Schedule (PANAS)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Baseline
|
A scale the assesses the presence and the intensity of anxiety and depressive symptoms. |
Baseline
|
|
Score on the Pittsburgh Sleep Quality Index
Periodo de tiempo: Baseline
|
A questionnaire assessing the quality of sleep. |
Baseline
|
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Score on the Multidimensional Assessment of Interoceptive Awareness (MAIA)
Periodo de tiempo: Baseline
|
A questionnaire assessing interoceptive awarness. |
Baseline
|
|
Score on the Inclusion of Others in the Self test (IOS)
Periodo de tiempo: 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)
Periodo de tiempo: Baseline
|
A test assessing cognitive functions such as memory, attention, language, and executive functions. |
Baseline
|
|
Score on the Satisfaction with Life Scale (SLS)
Periodo de tiempo: Baseline
|
A scale assessing satisfaction in life. |
Baseline
|
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Motor symptoms severity
Periodo de tiempo: Baseline
|
Motor symptoms severity (from level A to E) based on the International Standards for Neurological Classification of spinal cord injury (ISNCSCI) |
Baseline
|
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Demographics
Periodo de tiempo: Baseline
|
Demographic information such as age, sex and education level, as well as time since injury. |
Baseline
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2024-13
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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