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

Recruiting

• Conditions: Spinal Cord Injury

• Registration Number: NCT06309888
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-26
• Study Start: 2024-02-01
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Study First Posted: 2024-03-13
• Last Update Posted: 2024-03-13
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain activity	Baseline	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

Secondary Outcome Measures

Name	Time	Method
Behavioral performance	Baseline	Number of mistakes on verbal fluency task
Level of life satisfaction	Baseline	Satisfaction with Life Scale (validated questionnaire assessing life satisfaction)
Level of anxiety	Baseline	State-Trait Anxiety Inventory (validated questionnaire assessing anxiety)
Level of pain	Baseline	Validated questionnaire assessing pain severity
Quality of sleep	Baseline	Pittsburgh Sleep Quality Index (validated questionnaire assessing sleep quality)
Level of attention and awareness	Baseline	Mindful Attention and Awareness scale (validated questionnaire assessing level of attention and awareness)
Brain morphometry	Baseline	Volume of brain structures in cubic millimetres
Motor symptom severity	Baseline	Motor symptoms severity (from level A to E) based on the International Standards for Neurological Classification of spinal cord injury (ISNCSCI)
Demographics	Baseline	Demographic information such as age, sex and education level, as well as time since injury

Trial Locations

Locations (1)

Swiss Paraplegic Research; 🇨🇭 Nottwil, Lucerne, Switzerland