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Recruiting NCT06688916

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

— Observational Spinal Cord Injuries (SCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Behavioral assessment, Functional Magnetic Resonance Imaging (fMRI).
Who it may be relevant to
Registry conditions: Spinal Cord Injuries (SCI). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Behavioral 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.
  • Behavioral 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

Primary outcome measures

  • Score on the Body Feelings and Illusions questionnaire (BoFI) [Time frame: Baseline]
Secondary outcome measures (12)
  • Brain activity [Time frame: Baseline]
  • Strenght of the embodiment illusion [Time frame: Baseline]
  • Qualitative assessment of embodiment [Time frame: Baseline]
  • Score on the WHO Disability Assessment Scale (WHODAS-II) [Time frame: Baseline]
  • Pain severity [Time frame: Baseline]
  • Score on the Positive and Negative Affect Schedule (PANAS) [Time frame: Baseline]
  • Anxiety score on the Hospital Anxiety and Depression Scale (HADS) [Time frame: Baseline]
  • Depression score on the Hospital Anxiety and Depression Scale (HADS) [Time frame: Baseline]
  • Score on the Pittsburgh Sleep Quality Index [Time frame: Baseline]
  • Score on the Multidimensional Assessment of Interoceptive Awareness (MAIA) [Time frame: Baseline]
  • Score on the Inclusion of Others in the Self test (IOS) [Time frame: Baseline]
  • Score on the Montreal Cognitive Assessment (MoCA) [Time frame: Baseline]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Switzerland · 1 center
  • Swiss Paraplegic Research — Nottwil

Identifiers

NCT: NCT06688916 · 2024-13

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗