NCT06309888

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2024

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

10 months

First QC Date

January 26, 2024

Last Update Submit

November 17, 2025

Conditions

Keywords

spinal cord injuryneuroimagingcognitionexecutive functions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Behavioral performance

    Baseline

  • Behavioral performance

    Baseline

  • Behavioral performance

    Baseline

  • Behavioral performance

    Baseline

  • Behavioral performance

    Baseline

  • +8 more secondary outcomes

Study Arms (2)

spinal cord injury

Individuals living with a spinal cord injury

non spinal cord injury

able-bodied individuals

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Individuals with SCI and healthy controls will be recruited for the study considering age-matching.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Research

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2024

First Posted

March 13, 2024

Study Start

February 1, 2024

Primary Completion

November 18, 2024

Study Completion

November 18, 2024

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

The investigators plan to save anonymised data into public repositories, but given the size of imaging data, they are still undecided.

Locations