- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06309888
Magnetic Resonance Imaging of Cognitive Deficits in the Brain of Individuals With Spinal Cord Injury (SCI_Cog)
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Canton of Lucerne
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Nottwil, Canton of Lucerne, Switzerland, 6207
- Swiss Paraplegic Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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spinal cord injury
Individuals living with a spinal cord injury
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non spinal cord injury
able-bodied individuals
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Brain activity
Time Frame: Baseline
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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
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Behavioral performance
Time Frame: Baseline
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Accuracy on cognitive inhibition task (in percentage)
|
Baseline
|
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Behavioral performance
Time Frame: Baseline
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Reaction time (in milliseconds) on cognitive inhibition task
|
Baseline
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Behavioral performance
Time Frame: Baseline
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Number of errors on cognitive inhibition task
|
Baseline
|
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Behavioral performance
Time Frame: Baseline
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Number of correct words on verbal fluency task
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Baseline
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Behavioral performance
Time Frame: Baseline
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Number of mistakes on verbal fluency task
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Baseline
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Brain morphometry
Time Frame: Baseline
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Volume of brain structures in cubic millimetres
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Baseline
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Level of life satisfaction
Time Frame: Baseline
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Satisfaction with Life Scale (validated questionnaire assessing life satisfaction)
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Baseline
|
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Level of anxiety
Time Frame: Baseline
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State-Trait Anxiety Inventory (validated questionnaire assessing anxiety)
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Baseline
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Level of pain
Time Frame: Baseline
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Validated questionnaire assessing pain severity
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Baseline
|
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Quality of sleep
Time Frame: Baseline
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Pittsburgh Sleep Quality Index (validated questionnaire assessing sleep quality)
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Baseline
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Level of attention and awareness
Time Frame: Baseline
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Mindful Attention and Awareness scale (validated questionnaire assessing level of attention and awareness)
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Baseline
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Motor symptom severity
Time Frame: Baseline
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Motor symptoms severity (from level A to E) based on the International Standards for Neurological Classification of spinal cord injury (ISNCSCI)
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Baseline
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Demographics
Time Frame: Baseline
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Demographic information such as age, sex and education level, as well as time since injury
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Baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord Injury
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Ecole Polytechnique Fédérale de LausanneRecruitingChronic Spinal Cord Injury | Spinal Cord Injury (SCI) | Spinal Cord Injury | SCI - Spinal Cord Injury | SCI | Subacute Spinal Cord InjurySwitzerland
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Xuanwu Hospital, BeijingBeijing Pins Medical Co., Ltd; Beijing Xinzhida Neural Technology Co., Ltd; Hangzhou...RecruitingSpinal Cord Injury | Motor Deficits | Gait Impairment | Gait Training | Spinal Cord Injury Cervical | Spinal Cord Injuries (SCI) | Motor Impairment | Spinal Cord Injury, Chronic | Spinal Cord Injury Thoracic | Spinal Cord Injury (Quadraplegia)China
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Taipei Veterans General Hospital, TaiwanThe Industrial Technology Research InstituteUnknownSpinal Cord Injuries | Complete Spinal Cord Injury | Incomplete Spinal Cord InjuryTaiwan
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Chang Gung Memorial HospitalNot yet recruitingSpine Injury | Complete Spinal Cord Injury | Incomplete Spinal Cord Injury | Cord Injury, Spinal | Cord Infarction Spinal
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University of FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedSCI - Spinal Cord Injury | Incomplete Spinal Cord InjuryUnited States
-
Jill M. Wecht, Ed.D.Icahn School of Medicine at Mount SinaiRecruitingBlood Pressure | Spinal Cord Injuries | SCI - Spinal Cord Injury | Blood Pressure Disorders | Traumatic Spinal Cord Injury | Acute Spinal Cord Injury | Neuromodulation | Spinal Cord StimulationUnited States
-
NervGen PharmaTerminatedSpinal Cord Injuries | Chronic Spinal Cord Injury | Subacute Spinal Cord InjuryUnited States
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MetroHealth Medical CenterNational Institute of Neurological Disorders and Stroke (NINDS); Case Western...RecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury CervicalUnited States
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Anne BrydenNational Institute of Neurological Disorders and Stroke (NINDS); Case Western... and other collaboratorsRecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury Cervical | Spinal Cord Injury at C5-C7 Level With Complete Lesion | Spinal Cord Injury at C5-C7 Level With Incomplete LesionUnited States