Clinical trial NCT06309888: Magnetic Resonance Imaging of Cognitive Deficits in the Brain of Individuals With Spinal Cord Injury
Official title: Magnetic Resonance Imaging of Cognitive Deficits in the Brain of Individuals With Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
neuroimaging
cognition
executive functions
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2024-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with SCI and healthy controls will be recruited for the study considering age-matching.

Brief summary: In the case of spinal cord injury, rehabilitation is particularly focused on motor skills. Non-motor impairments such as thinking difficulties did not receive a lot of attention to date.

In this research project, the investigators want to find out how thinking difficulties become noticeable in the brain with spinal cord injury.

Participation procedure: Participants who take part will be asked to come to an examination once. The duration of the examination is between 2 and 2.5 hours (including around 55 minutes in the magnetic resonance imaging scanner, including preparation and follow-up).


Eligibility criteria: Inclusion criteria (with and without spinal cord injury):

* Male or Female
* Age between 18 and 60
* German native speaker
* Normal or corrected-to-normal visual acuity

Additional inclusion criteria (spinal cord injury only):

* A diagnosis of traumatic spinal cord injury (SCI)
* Time since injury 12 months or longer
* American Spinal Injury Association Impairment Scale (AIS) grade A, B, C and D

Exclusion criteria (with and without spinal cord injury):

* Contraindication for magnetic resonance imaging examinations (e.g., cardiac pacemaker etc.)
* Pregnancy
* Diagnosis of other psychiatric or neurological disorders (including tumor in the central nervous system)
* Alcohol and/or drug abuse
* Confirmed diagnosis of traumatic brain injury
* Insufficient hand function (not able to hold a pen due to the restricted motor abilities)

Primary outcomes:
measure: Brain activity
timeFrame: Baseline
Secondary outcomes:
measure: Behavioral performance
timeFrame: Baseline
measure: Behavioral performance
timeFrame: Baseline
measure: Behavioral performance
timeFrame: Baseline
measure: Behavioral performance
timeFrame: Baseline
measure: Behavioral performance
timeFrame: Baseline
measure: Brain morphometry
timeFrame: Baseline
measure: Level of life satisfaction
timeFrame: Baseline
measure: Level of anxiety
timeFrame: Baseline
measure: Level of pain
timeFrame: Baseline
measure: Quality of sleep
timeFrame: Baseline
measure: Level of attention and awareness
timeFrame: Baseline
measure: Motor symptom severity
timeFrame: Baseline
measure: Demographics
timeFrame: Baseline
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Research
state: Lucerne
Study officials:
References: