Spinal Cord InjurySCI_CogNCT06309888
Magnetic Resonance Imaging of Cognitive Deficits in the Brain of Individuals With Spinal Cord Injury
An observational study of Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 54 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2024to 18 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals with SCI and healthy controls will be recruited for the study considering age-matching.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Research
Nottwil, Canton of Lucerne, 6207
About this study
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).
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, neuroimaging, cognition, executive functions
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| spinal cord injury | Individuals living with a spinal cord injury | |
| non spinal cord injury | able-bodied individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (13)
Behavioral performance
Accuracy on cognitive inhibition task (in percentage)
Measured: Baseline
Behavioral performance
Reaction time (in milliseconds) on cognitive inhibition task
Measured: Baseline
Behavioral performance
Number of errors on cognitive inhibition task
Measured: Baseline
Behavioral performance
Number of correct words on verbal fluency task
Measured: Baseline
Behavioral performance
Number of mistakes on verbal fluency task
Measured: Baseline
Brain morphometry
Volume of brain structures in cubic millimetres
Measured: Baseline
Level of life satisfaction
Satisfaction with Life Scale (validated questionnaire assessing life satisfaction)
Measured: Baseline
Level of anxiety
State-Trait Anxiety Inventory (validated questionnaire assessing anxiety)
Measured: Baseline
Level of pain
Validated questionnaire assessing pain severity
Measured: Baseline
Quality of sleep
Pittsburgh Sleep Quality Index (validated questionnaire assessing sleep quality)
Measured: Baseline
Level of attention and awareness
Mindful Attention and Awareness scale (validated questionnaire assessing level of attention and awareness)
Measured: Baseline
Motor symptom severity
Motor symptoms severity (from level A to E) based on the International Standards for Neurological Classification of spinal cord injury (ISNCSCI)
Measured: Baseline
Demographics
Demographic information such as age, sex and education level, as well as time since injury
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Feb 2024
- Primary completion18 Nov 2024
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309888
- Sponsor's protocol ID
- 2023-18
- Acronym
- SCI_Cog
- Status last verified
- Nov 2025
- First submitted
- 26 Jan 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators plan to save anonymised data into public repositories, but given the size of imaging data, they are still undecided.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging of Cognitive Deficits in the Brain of Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06309888
- Acronym / sponsor ID
- SCI_Cog / 2023-18
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, neuroimaging, cognition, executive functions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal cord injury | – | –Individuals living with a spinal cord injury |
| non spinal cord injury | – | –able-bodied individuals |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals with SCI and healthy controls will be recruited for the study considering age-matching.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
13 secondary outcomes
Behavioral performance
Time frame: Baseline
Behavioral performance
Time frame: Baseline
Behavioral performance
Time frame: Baseline
Behavioral performance
Time frame: Baseline
Behavioral performance
Time frame: Baseline
Brain morphometry
Time frame: Baseline
Level of life satisfaction
Time frame: Baseline
Level of anxiety
Time frame: Baseline
Level of pain
Time frame: Baseline
Quality of sleep
Time frame: Baseline
Level of attention and awareness
Time frame: Baseline
Motor symptom severity
Time frame: Baseline
Demographics
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No. The investigators plan to save anonymised data into public repositories, but given the size of imaging data, they are still undecided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.