Spinal Cord Injuries (SCI)SCI_EmbodimentNCT06688916
A Comprehensive Assessment of Altered Embodiment in Individuals With Spinal Cord Injury
An observational study of Spinal Cord Injuries (SCI), run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries (SCI)
- What is being tested?
- Behavioral assessment and Functional Magnetic Resonance Imaging (fMRI)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Jun 2025to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with spinal cord injury and healthy controls.
Who may be able to join
- 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).
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Swiss Paraplegic Research
Nottwil, Canton of Lucerne, 6207
Nicola Brunello, MSc, 0041419396578, nicola.brunello@paraplegie.ch
Nicola Brunello, MSc
About this study
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.
Read more
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).
- Conditions
- Spinal Cord Injuries (SCI)
- Being tested
- Behavioral assessment, Functional Magnetic Resonance Imaging (fMRI)
- Keywords
- spinal cord injury, embodiment, bodily sensations, magnetic resonance imaging, daily life
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral assessmentBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Behavioral assessment; Behavioral: Functional Magnetic Resonance Imaging (fMRI) | |
| Healthy controls - Behavioral assessment | 15 healthy controls will perform a comprehensive behavioral assessment of embodiment (see "Interventions"). Receives: 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"). Receives: Behavioral: Behavioral assessment; Behavioral: Functional Magnetic Resonance Imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the Body Feelings and Illusions questionnaire (BoFI)
A questionnaires that assess different dimensions of embodiment and disembodiment.
Measured: Baseline
Secondary outcomes (15)
Brain activity
Brain activity defined as changes in oxygen levels in the blood during the execution of the embodiment task, and at rest.
Measured: Baseline
Strenght of the embodiment illusion
Strenght of the embodiment illusion during the fMRI procedures, measured through a Likert scale.
Measured: Baseline
Qualitative assessment of embodiment
Qualitative assessment of the experience of embodiment by means of a semi-structured interview.
Measured: Baseline
Score on the WHO Disability Assessment Scale (WHODAS-II)
A scale that assesses activity limitation and participation restriction in the daily life due to disability.
Measured: Baseline
Pain severity
Intensity of pain measured on a visual analogue scale.
Measured: Baseline
Score on the Positive and Negative Affect Schedule (PANAS)
A scale which measures positive and negative sensations over the course of the last week.
Measured: Baseline
Anxiety score on the Hospital Anxiety and Depression Scale (HADS)
A scale the assesses the presence and the intensity of anxiety and depressive symptoms.
Measured: Baseline
Depression score on the Hospital Anxiety and Depression Scale (HADS)
A scale the assesses the presence and the intensity of anxiety and depressive symptoms.
Measured: Baseline
Score on the Pittsburgh Sleep Quality Index
A questionnaire assessing the quality of sleep.
Measured: Baseline
Score on the Multidimensional Assessment of Interoceptive Awareness (MAIA)
A questionnaire assessing interoceptive awarness.
Measured: Baseline
Score on the Inclusion of Others in the Self test (IOS)
A questionnaire assessing the relationship of the individual self with other entities (e.g., the body, the famiy, the society).
Measured: Baseline
Score on the Montreal Cognitive Assessment (MoCA)
A test assessing cognitive functions such as memory, attention, language, and executive functions.
Measured: Baseline
Score on the Satisfaction with Life Scale (SLS)
A scale assessing satisfaction in life.
Measured: Baseline
Motor symptoms severity
Motor symptoms severity (from level A to E) based on the International Standards for Neurological Classification of spinal cord injury (ISNCSCI)
Measured: Baseline
Demographics
Demographic information such as age, sex and education level, as well as time since injury.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start4 Jun 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688916
- Sponsor's protocol ID
- 2024-13
- Acronym
- SCI_Embodiment
- Status last verified
- Oct 2025
- First submitted
- 12 Nov 2024
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Assessment of Altered Embodiment in Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06688916
- Acronym / sponsor ID
- SCI_Embodiment / 2024-13
- Conditions
- Spinal Cord Injuries (SCI)
- Keywords
- spinal cord injury, embodiment, bodily sensations, magnetic resonance imaging, daily life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Individuals with SCI - Behavioral assessment | – | Behavioral: Behavioral assessment15 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. |
| Individuals with SCI - Behavioral assessment and fMRI | – | Behavioral: Behavioral assessment, Behavioral: Functional Magnetic Resonance Imaging (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. |
| Healthy controls - Behavioral assessment | – | Behavioral: Behavioral assessment15 healthy controls will perform a comprehensive behavioral assessment of embodiment (see "Interventions"). |
| Healthy controls - Behavioral assessment and fMRI | – | Behavioral: Behavioral assessment, Behavioral: Functional Magnetic Resonance Imaging (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"). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with spinal cord injury and healthy controls.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral assessmentA 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. | Behavioural | Healthy controls - Behavioral assessment, Healthy controls - Behavioral assessment and fMRI, Individuals with SCI - Behavioral assessment, Individuals with SCI - Behavioral assessment and fMRI |
| 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. | Behavioural | Healthy controls - Behavioral assessment and fMRI, Individuals with SCI - Behavioral assessment and fMRI |
Primary outcome
Score on the Body Feelings and Illusions questionnaire (BoFI)
Time frame: Baseline
A questionnaires that assess different dimensions of embodiment and disembodiment.
15 secondary outcomes
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
Score on the Satisfaction with Life Scale (SLS)
Time frame: Baseline
Motor symptoms severity
Time frame: Baseline
Demographics
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: No. 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.
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Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
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Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
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SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries (SCI), run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe A. Zito, Dr. (0041419395586, giuseppe.zito@paraplegie.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the Body Feelings and Illusions questionnaire (BoFI) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.