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NCT Number: NCT06688916

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

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).

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Key information

Conditions

Spinal Cord Injuries (SCI) Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Swiss Paraplegic Research

Nottwil, Canton of Lucerne, 6207, Switzerland

Location status: Recruiting

Location contact

Nicola Brunello, MSc

CONTACT

[email protected]

0041419396578

Nicola Brunello, MSc

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Behavioral Assessment

Behavioral

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.

functional magnetic resonance imaging (fMRI)

Behavioral

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.

Primary outcomes

  1. Score on the Body Feelings and Illusions questionnaire (BoFI)

    Time frame: Baseline

    A questionnaires that assess different dimensions of embodiment and disembodiment.

Secondary outcomes

  1. 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.

  2. Strenght of the embodiment illusion

    Time frame: Baseline

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

  3. Qualitative assessment of embodiment

    Time frame: Baseline

    Qualitative assessment of the experience of embodiment by means of a semi-structured interview.

  4. 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.

  5. Pain severity

    Time frame: Baseline

    Intensity of pain measured on a visual analogue scale.

  6. 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.

  7. 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.

  8. 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.

  9. Score on the Pittsburgh Sleep Quality Index

    Time frame: Baseline

    A questionnaire assessing the quality of sleep.

  10. Score on the Multidimensional Assessment of Interoceptive Awareness (MAIA)

    Time frame: Baseline

    A questionnaire assessing interoceptive awarness.

  11. 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).

  12. Score on the Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline

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

  13. Score on the Satisfaction with Life Scale (SLS)

    Time frame: Baseline

    A scale assessing satisfaction in life.

  14. 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)

  15. Demographics

    Time frame: Baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe A. Zito, Dr.

CONTACT

[email protected]

0041419395586

Nicola Brunello, MSc

CONTACT

[email protected]

0041419396578

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Acronym: SCI_Embodiment

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 14, 2024
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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