Spinal Cord InjuriesNCT03886610
Association of Quantitative and Functional Imaging With Clinical Outcome After Spinal Cord Injury
An observational study of Spinal Cord Injuries, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
The overall study aim is to provide additional magnetic resonance imaging parameters of the cervical spinal cord, brainstem and brain and a better understanding of changes after spinal cord injury (SCI) and to define new magnetic resonance (MR) biomarkers to correlate with sensomotoric functioning and clinical outcome. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Subacute SCI patients and Chronic SCI patients
- How many people
- 57 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Mar 2019to 31 Dec 2022
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * 20 healthy controls * 35 patients with subacute spinal cord injury * 20 patients with chronic spinal injury
Who may be able to join
- age between 18 and 80 years
- no previous history of severe cervical trauma, traumatic brain injury, cervical surgery or signs of neurological impairment and no known neurological disease.
- lesion level at or below C3
- etiology of the spinal cord injury is traumatic or non-traumatic
- age between 18 and 80 years
- time of trauma or onset of symptoms for subacute SCI patients is more than 3 weeks and for the chronic SCI patients more than 2 years
Who cannot join
- not meeting the MRI screening requirements
- unable to give consent
- unable to fulfill the above mentioned inclusion criteria
- Subacute and chronic patients with spinal cord injury:
- lesion level below L2
- other known pathology of the spinal cord/brain (e.g. MS) or progressive neurological disorders
Show all 9Show fewer
- inability to meet the MRI screening requirements (e.g. pacemaker or other electronic devices),
- severe head trauma as defined by a Glasgow Coma Scale (GCS) of < 14
- patients who are ventilator dependant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative and Functional Longitudinal Multimodal Imaging of the Brain and Cervical Spinal Cord in Spinal Cord Injury: Correlation With Clinical Outcome
The overall study aim is to provide additional magnetic resonance imaging parameters of the cervical spinal cord, brainstem and brain and a better understanding of changes after spinal cord injury (SCI) and to define new magnetic resonance (MR) biomarkers to correlate with sensomotoric functioning and clinical outcome.
Read the detailed description
Injury of the spinal cord, for instance induced by trauma, is complex involving primary mechanisms caused by forces directly affecting the spinal cord and secondary mechanisms consisting of complex physiological processes after trauma.
Conventional magnetic resonance imaging (MRI) is the current standard to assess morphologic changes of the spinal cord after injury. However, conventional MRI provides little information regarding the health and integrity of the brain and spinal cord tissue itself, due to the fact that signal intensity changes are non-specific and do not correspond directly with physiological processes. This is reflected in the poor correlation of conventional MRI data with neurological and functional impairment in various spinal cord pathologies (such as multiple sclerosis compression myelopathy) and failure to provide reliable prognostic information.
By applying a combination of diffusion weighted imaging, functional MRI and magnetic resonance spectroscopy will give us a better understanding of the changes after injury of the cervical spinal cord, brainstem and brain. Correlating the imaging data with the neurological and clinical status of patients could improve the patient status prediction and therapy planning.
This study is divided into three sub-projects:
- Reproducibility study of the MR measurements in healthy controls ii) Progression of MR biomarkers in subacute patients with SCI and comparison to chronic patients with SCI iii) Prediction of clinical outcome based on MR biomarkers
- Conditions
- Spinal Cord Injuries
- Being tested
- Healthy controls, Subacute SCI patients, Chronic SCI patients
- 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.
Healthy controlsOther
individuals without spinal cord injury
Subacute SCI patientsOther
individuals with spinal cord injury ≥ 2 weeks
Chronic SCI patientsOther
individuals with spinal cord injury ≥ 24 months
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Individuals without spinal cord injury Receives: Other: Healthy controls | |
| Subacute SCI patients | Subacute patients with spinal cord injury (duration >2 weeks) Receives: Other: Subacute SCI patients | |
| Chronic SCI patients | Patients with chronic spinal cord injury (duration ≥24 months) Receives: Other: Chronic SCI patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fractional Anisotropy (FA)
Degree of anisotropy of a diffusion process (value between zero and one). A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. FA is a measure often used in diffusion imaging where it is thought to reflect fiber density, axonal diameter, and myelination in white matter.
Measured: 16-40 days after injury, 70-96 days after injury, 150- 186 days after injury
Secondary outcomes (2)
Change in Apparent Diffusion Coefficient (ADC)
Measurement of the magnitude of diffusion (of water molecules) within tissue
Measured: 16-40 days after injury, 70-96 days after injury, 150- 186 days after injury
Change in Relative Anisotropy (RA)
Measurement of the relative diffusion (of water molecules) within tissue
Measured: 16-40 days after injury, 70-96 days after injury, 150- 186 days after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start27 Mar 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Collaborators
- UMC Utrecht
- Responsible party
- Principal investigator, Christiaanse Ernst, Swiss Paraplegic Research, Nottwil
- Investigators
- Ernst Christiaanse, MD, Principal investigator, Swiss Paraplegic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886610
- Sponsor's protocol ID
- 2018-37
- Status last verified
- Mar 2023
- First submitted
- 21 Mar 2019
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative and Functional Longitudinal Multimodal Imaging of the Brain and Cervical Spinal Cord in Spinal Cord Injury: Correlation With Clinical Outcome
- ClinicalTrials.gov ID
- NCT03886610
- Acronym / sponsor ID
- 2018-37
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Collaborators
- UMC Utrecht
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Mar 2019 (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.
The overall study aim is to provide additional magnetic resonance imaging parameters of the cervical spinal cord, brainstem and brain and a better understanding of changes after spinal cord injury (SCI) and to define new magnetic resonance (MR) biomarkers to correlate with sensomotoric functioning and clinical outcome.
Detailed description
Injury of the spinal cord, for instance induced by trauma, is complex involving primary mechanisms caused by forces directly affecting the spinal cord and secondary mechanisms consisting of complex physiological processes after trauma.
Conventional magnetic resonance imaging (MRI) is the current standard to assess morphologic changes of the spinal cord after injury. However, conventional MRI provides little information regarding the health and integrity of the brain and spinal cord tissue itself, due to the fact that signal intensity changes are non-specific and do not correspond directly with physiological processes. This is reflected in the poor correlation of conventional MRI data with neurological and functional impairment in various spinal cord pathologies (such as multiple sclerosis compression myelopathy) and failure to provide reliable prognostic information.
By applying a combination of diffusion weighted imaging, functional MRI and magnetic resonance spectroscopy will give us a better understanding of the changes after injury of the cervical spinal cord, brainstem and brain. Correlating the imaging data with the neurological and clinical status of patients could improve the patient status prediction and therapy planning.
This study is divided into three sub-projects:
- Reproducibility study of the MR measurements in healthy controls ii) Progression of MR biomarkers in subacute patients with SCI and comparison to chronic patients with SCI iii) Prediction of clinical outcome based on MR biomarkers
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Other: Healthy controlsIndividuals without spinal cord injury |
| Subacute SCI patients | – | Other: Subacute SCI patientsSubacute patients with spinal cord injury (duration >2 weeks) |
| Chronic SCI patients | – | Other: Chronic SCI patientsPatients with chronic spinal cord injury (duration ≥24 months) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * 20 healthy controls * 35 patients with subacute spinal cord injury * 20 patients with chronic spinal injury
Key inclusion criteria (6 listed)
- age between 18 and 80 years
- no previous history of severe cervical trauma, traumatic brain injury, cervical surgery or signs of neurological impairment and no known neurological disease.
- lesion level at or below C3
- etiology of the spinal cord injury is traumatic or non-traumatic
- age between 18 and 80 years
Key exclusion criteria (9 listed)
- not meeting the MRI screening requirements
- unable to give consent
- unable to fulfill the above mentioned inclusion criteria
- lesion level below L2
- other known pathology of the spinal cord/brain (e.g. MS) or progressive neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy controlsindividuals without spinal cord injury | Other | Healthy controls |
| Subacute SCI patientsindividuals with spinal cord injury ≥ 2 weeks | Other | Subacute SCI patients |
| Chronic SCI patientsindividuals with spinal cord injury ≥ 24 months | Other | Chronic SCI patients |
Primary outcome
Change in Fractional Anisotropy (FA)
Time frame: 16-40 days after injury, 70-96 days after injury, 150- 186 days after injury
Degree of anisotropy of a diffusion process (value between zero and one). A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. FA is a measure often used in diffusion imaging where it is thought to reflect fiber density, axonal diameter, and myelination in white matter.
2 secondary outcomes
Change in Apparent Diffusion Coefficient (ADC)
Time frame: 16-40 days after injury, 70-96 days after injury, 150- 186 days after injury
Change in Relative Anisotropy (RA)
Time frame: 16-40 days after injury, 70-96 days after injury, 150- 186 days after injury
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 13 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Ernst Christiaanse, MD principal investigator
Swiss Paraplegic Centre
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 Injuries, 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 6 inclusion and 9 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 13 Mar 2023. 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?
Change in Fractional Anisotropy (FA) (time frame: 16-40 days after injury, 70-96 days after injury, 150- 186 days after injury). 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 13 Mar 2023.