Magnetic Resonance Imaging of Cognitive Deficits in the Brain of Individuals With Spinal Cord Injury

Spinal Cord Injury Clinical Trial

— SCI_Cog  

Official title:

Magnetic Resonance Imaging of Cognitive Deficits in the Brain of Individuals With Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06309888
• Other study ID #: 2023-18
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Swiss Paraplegic Research, Nottwil
• Contact: Giuseppe Zito, Dr.
• Phone: 0041419395586
• Email: giuseppe.zito[@]paraplegie.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Research	Nottwil	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Research, Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain activity	Brain activity defined as changes in oxygen levels in the blood during the execution of cognitive tasks on cognitive inhibition and verbal fluency (executive functions), and at rest	Baseline
Secondary	Behavioral performance	Accuracy on cognitive inhibition task (in percentage)	Baseline
Secondary	Behavioral performance	Reaction time (in milliseconds) on cognitive inhibition task	Baseline
Secondary	Behavioral performance	Number of errors on cognitive inhibition task	Baseline
Secondary	Behavioral performance	Number of correct words on verbal fluency task	Baseline
Secondary	Behavioral performance	Number of mistakes on verbal fluency task	Baseline
Secondary	Brain morphometry	Volume of brain structures in cubic millimetres	Baseline
Secondary	Level of life satisfaction	Satisfaction with Life Scale (validated questionnaire assessing life satisfaction)	Baseline
Secondary	Level of anxiety	State-Trait Anxiety Inventory (validated questionnaire assessing anxiety)	Baseline
Secondary	Level of pain	Validated questionnaire assessing pain severity	Baseline
Secondary	Quality of sleep	Pittsburgh Sleep Quality Index (validated questionnaire assessing sleep quality)	Baseline
Secondary	Level of attention and awareness	Mindful Attention and Awareness scale (validated questionnaire assessing level of attention and awareness)	Baseline
Secondary	Motor symptom severity	Motor symptoms severity (from level A to E) based on the International Standards for Neurological Classification of spinal cord injury (ISNCSCI)	Baseline
Secondary	Demographics	Demographic information such as age, sex and education level, as well as time since injury	Baseline