Идёт набор NCT06688916

A Comprehensive Assessment of Altered Embodiment in Individuals With Spinal Cord Injury

— Наблюдательное Spinal Cord Injuries (SCI)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Behavioral assessment, Functional Magnetic Resonance Imaging (fMRI).
Кому может быть актуально: Состояния в реестре: Spinal Cord Injuries (SCI). Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Швейцария
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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).

Вмешательства

Поведенческое Behavioral assessment
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.
Поведенческое Functional Magnetic Resonance Imaging (fMRI)
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 sh

Первичные конечные точки

Score on the Body Feelings and Illusions questionnaire (BoFI) [Срок оценки: Baseline]

Вторичные конечные точки (12)

Brain activity [Срок оценки: Baseline]
Strenght of the embodiment illusion [Срок оценки: Baseline]
Qualitative assessment of embodiment [Срок оценки: Baseline]
Score on the WHO Disability Assessment Scale (WHODAS-II) [Срок оценки: Baseline]
Pain severity [Срок оценки: Baseline]
Score on the Positive and Negative Affect Schedule (PANAS) [Срок оценки: Baseline]
Anxiety score on the Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Baseline]
Depression score on the Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Baseline]
Score on the Pittsburgh Sleep Quality Index [Срок оценки: Baseline]
Score on the Multidimensional Assessment of Interoceptive Awareness (MAIA) [Срок оценки: Baseline]
Score on the Inclusion of Others in the Self test (IOS) [Срок оценки: Baseline]
Score on the Montreal Cognitive Assessment (MoCA) [Срок оценки: Baseline]

Критерии участия

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: