NCT06688916

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

June 4, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

October 8, 2025

Status Verified

October 1, 2025

Enrollment Period

11 months

First QC Date

November 12, 2024

Last Update Submit

October 2, 2025

Conditions

Keywords

spinal cord injuryembodimentbodily sensationsmagnetic resonance imagingdaily life

Outcome Measures

Primary Outcomes (1)

  • Score on the Body Feelings and Illusions questionnaire (BoFI)

    A questionnaires that assess different dimensions of embodiment and disembodiment.

    Baseline

Secondary Outcomes (15)

  • Brain activity

    Baseline

  • Strenght of the embodiment illusion

    Baseline

  • Qualitative assessment of embodiment

    Baseline

  • Score on the WHO Disability Assessment Scale (WHODAS-II)

    Baseline

  • Pain severity

    Baseline

  • +10 more secondary outcomes

Study Arms (4)

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

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 assessmentBehavioral: Functional Magnetic Resonance Imaging (fMRI)

Healthy controls - Behavioral assessment

15 healthy controls will perform a comprehensive behavioral assessment of embodiment (see "Interventions").

Behavioral: Behavioral assessment

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 assessmentBehavioral: Functional Magnetic Resonance Imaging (fMRI)

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 assessmentHealthy controls - Behavioral assessment and fMRIIndividuals with SCI - Behavioral assessmentIndividuals with SCI - Behavioral assessment and 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 and fMRIIndividuals with SCI - Behavioral assessment and fMRI

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals with spinal cord injury and healthy controls.

You may qualify if:

  • Age between 18 and 60
  • Normal or corrected-to-normal visual acuity
  • German or Italian native speaker
  • 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).

You may not qualify if:

  • 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)
  • Active medical devices (e.g. cardiac pacemaker)
  • Inability to perform study procedures (e.g. claustrophobia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Research

Nottwil, Canton of Lucerne, 6207, Switzerland

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Giuseppe A. Zito, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 14, 2024

Study Start

June 4, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

October 8, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

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.

Locations