Clinical trial NCT06688916: A Comprehensive Assessment of Altered Embodiment in Individuals With Spinal Cord Injury
Official title: A Comprehensive Assessment of Altered Embodiment in Individuals With Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Spinal Cord Injuries (SCI)
Keywords: spinal cord injury
embodiment
bodily sensations
magnetic resonance imaging
daily life
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2024-11-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with spinal cord injury and healthy controls.

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).


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)

Primary outcomes:
measure: Score on the Body Feelings and Illusions questionnaire (BoFI)
timeFrame: Baseline
Secondary outcomes:
measure: Brain activity
timeFrame: Baseline
measure: Strenght of the embodiment illusion
timeFrame: Baseline
measure: Qualitative assessment of embodiment
timeFrame: Baseline
measure: Score on the WHO Disability Assessment Scale (WHODAS-II)
timeFrame: Baseline
measure: Pain severity
timeFrame: Baseline
measure: Score on the Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline
measure: Anxiety score on the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline
measure: Depression score on the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline
measure: Score on the Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: Score on the Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: Baseline
measure: Score on the Inclusion of Others in the Self test (IOS)
timeFrame: Baseline
measure: Score on the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline
measure: Score on the Satisfaction with Life Scale (SLS)
timeFrame: Baseline
measure: Motor symptoms severity
timeFrame: Baseline
measure: Demographics
timeFrame: Baseline
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Research
state: Lucerne
Study officials:
References: