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OpenTrials
Completed

NCT Number: NCT06309888

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

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).

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Swiss Paraplegic Research

Nottwil, Canton of Lucerne, 6207, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Brain activity

    Time frame: 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 outcomes

  1. Behavioral performance

    Time frame: Baseline

    Accuracy on cognitive inhibition task (in percentage)

  2. Behavioral performance

    Time frame: Baseline

    Reaction time (in milliseconds) on cognitive inhibition task

  3. Behavioral performance

    Time frame: Baseline

    Number of errors on cognitive inhibition task

  4. Behavioral performance

    Time frame: Baseline

    Number of correct words on verbal fluency task

  5. Behavioral performance

    Time frame: Baseline

    Number of mistakes on verbal fluency task

  6. Brain morphometry

    Time frame: Baseline

    Volume of brain structures in cubic millimetres

  7. Level of life satisfaction

    Time frame: Baseline

    Satisfaction with Life Scale (validated questionnaire assessing life satisfaction)

  8. Level of anxiety

    Time frame: Baseline

    State-Trait Anxiety Inventory (validated questionnaire assessing anxiety)

  9. Level of pain

    Time frame: Baseline

    Validated questionnaire assessing pain severity

  10. Quality of sleep

    Time frame: Baseline

    Pittsburgh Sleep Quality Index (validated questionnaire assessing sleep quality)

  11. Level of attention and awareness

    Time frame: Baseline

    Mindful Attention and Awareness scale (validated questionnaire assessing level of attention and awareness)

  12. Motor symptom severity

    Time frame: Baseline

    Motor symptoms severity (from level A to E) based on the International Standards for Neurological Classification of spinal cord injury (ISNCSCI)

  13. Demographics

    Time frame: Baseline

    Demographic information such as age, sex and education level, as well as time since injury

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Acronym: SCI_Cog

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2024
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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