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

October 2, 2025 updated by: 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
    • Canton of Lucerne
      • Nottwil, Canton of Lucerne, Switzerland, 6207
        • Recruiting
        • Swiss Paraplegic Research
        • Contact:
        • Sub-Investigator:
          • Nicola Brunello, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Individuals with spinal cord injury and healthy controls.

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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.
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 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").
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.
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").
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score on the Body Feelings and Illusions questionnaire (BoFI)
Time Frame: Baseline
A questionnaires that assess different dimensions of embodiment and disembodiment.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain activity
Time Frame: 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
Time Frame: Baseline
Strenght of the embodiment illusion during the fMRI procedures, measured through a Likert scale.
Baseline
Qualitative assessment of embodiment
Time Frame: 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)
Time Frame: Baseline
A scale that assesses activity limitation and participation restriction in the daily life due to disability.
Baseline
Pain severity
Time Frame: Baseline
Intensity of pain measured on a visual analogue scale.
Baseline
Score on the Positive and Negative Affect Schedule (PANAS)
Time Frame: 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)
Time Frame: 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)
Time Frame: Baseline
A scale the assesses the presence and the intensity of anxiety and depressive symptoms.
Baseline
Score on the Pittsburgh Sleep Quality Index
Time Frame: Baseline
A questionnaire assessing the quality of sleep.
Baseline
Score on the Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time Frame: Baseline
A questionnaire assessing interoceptive awarness.
Baseline
Score on the Inclusion of Others in the Self test (IOS)
Time Frame: 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)
Time Frame: Baseline
A test assessing cognitive functions such as memory, attention, language, and executive functions.
Baseline
Score on the Satisfaction with Life Scale (SLS)
Time Frame: Baseline
A scale assessing satisfaction in life.
Baseline
Motor symptoms severity
Time Frame: Baseline
Motor symptoms severity (from level A to E) based on the International Standards for Neurological Classification of spinal cord injury (ISNCSCI)
Baseline
Demographics
Time Frame: Baseline
Demographic information such as age, sex and education level, as well as time since injury.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Paraplegic Research, Nottwil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

October 8, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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