Paraplegia, SpinalNCT01208584
Brain Function and White Matter Changes in Congenital, Acute and Chronic Spinal Cord Lesions
An observational study of Paraplegia, Spinal and Myelomeningocele, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The purpose of this study is to use functional MRI (fMRI) and magnetic resonance (MR) diffusion tensor imaging (DTI) to investigate brain activation and white matter changes in patients with congenital (birth defect of the spinal column), acute and chronic complete spinal cord lesions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Paraplegia, Spinal, Myelomeningocele
- What is being tested?
- fMRI, DTI
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2008to Oct 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Paraplegic patients (Thoracic level of lesion Th1-Th12), ASIA A * Myelomeningocele patients (congenital paraplegia, thoracic level of lesion Th1-Th12) ASIA A * Volunteers without any neurological deficits
Who may be able to join
- Paraplegic patients (Th1-Th12, ASIA A),
- Myelomeningocele patients (Th1-Th12 ASIA A)
- Acute SCI 2-6 months, chronic SCI 12-24 months
Who cannot join
- Traumatic brain injury (TBI)
- Neurological diseases other than spinal cord lesion
- MRI incompatibility
- Pressure sores
- methicillin-resistant Staphylococcus aureus (MRSA)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to use functional MRI (fMRI) and magnetic resonance (MR) diffusion tensor imaging (DTI) to investigate brain activation and white matter changes in patients with congenital (birth defect of the spinal column), acute and chronic complete spinal cord lesions. The findings of this study may provide a basis to better understand the pathomechanisms underlying the dynamic neurofunctional changes following a spinal cord lesions in man. This understanding is important for the improvement of existing therapies and for the development of new therapeutic approaches.
Read the detailed description
Recently new approaches to spinal cord repair have been successfully established in animal models. Promising therapies for promoting spinal axonal regeneration in man will be available in the near future. Most research in the field is focussed on the lesion itself and the perilesional spinal cord. The recovery of motor and sensory function is,however, not permitted by local processes at the spinal level only. The whole central nervous system (CNS) reacts to such a condition. Therefore the modulation of motor and sensory function in spinal cord lesioned patients should be reflected in characteristic changes of cortical brain activity, which are accessible to new non-invasive functional neuroimaging techniques such as functional magnetic resonance imaging (fMRI). Changes of white matter due to axonal damage can also be measured qualitatively and quantitatively using MR diffusion tensor imaging (DTI). Those measures may provide a basis to better understand the pathophysiology underlying spinal cord lesions in man, including changes in brain function over time (during rehabilitation) or related to specific treatment. However, there are no studies available yet addressing those topics or providing mechanism-based approaches for determining the time interval of application of novel neuroregenerative drugs. By investigation of brain activation and white matter changes in patients with congenital(myelomeningocele (MMC)), acute and chronic spinal cord lesions (ASIA A) first and fundamental work in this field will be conducted in this study.
- Conditions
- Paraplegia, Spinal, Myelomeningocele
- Being tested
- fMRI, DTI
- Keywords
- functional MRI,primary motor cortex,spinal cord injury
- Medical subject headings
- Paraplegia, Meningomyelocele, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI, DTIOther
functional magnetic resonance imaging (fMRI), MR diffusion tensor imaging (DTI)
| Study group | Role | What they receive |
|---|---|---|
| Chronic posttraumatic paraplegia | Paraplegic patients (Thoracic level of lesion Th1-Th12), ASIA A, spinal cord injury (SCI) 12-24 months Receives: Other: fMRI, DTI | |
| Acute posttraumatic paraplegia | Paraplegic patients (Thoracic level of lesion Th1-Th12), ASIA A,SCI 2-6 months, Receives: Other: fMRI, DTI | |
| Myelomeningocele patients | Myelomeningocele patients (congenital paraplegia, thoracic level of lesion Th1-Th12) ASIA A Receives: Other: fMRI, DTI | |
| Volunteers | Volunteers without any neurological deficits Receives: Other: fMRI, DTI |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startAug 2008
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paraplegia, SpinalStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University
- Responsible party
- Sponsor
- Investigators
- Christoph Stippich, Prof, Principal investigator, University Hospital, Basle - Department of Neuroradiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208584
- Sponsor's protocol ID
- 306/09
- Status last verified
- Mar 2015
- First submitted
- 23 Sep 2010
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Function and White Matter Changes in Congenital, Acute and Chronic Spinal Cord Lesions
- ClinicalTrials.gov ID
- NCT01208584
- Acronym / sponsor ID
- 306/09
- Conditions
- Paraplegia, Spinal, Myelomeningocele
- Keywords
- functional MRI,primary motor cortex,spinal cord injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Heidelberg University
- Study start
- Aug 2008
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 Sep 2010 (estimated)
- 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 purpose of this study is to use functional MRI (fMRI) and magnetic resonance (MR) diffusion tensor imaging (DTI) to investigate brain activation and white matter changes in patients with congenital (birth defect of the spinal column), acute and chronic complete spinal cord lesions. The findings of this study may provide a basis to better understand the pathomechanisms underlying the dynamic neurofunctional changes following a spinal cord lesions in man. This understanding is important for the improvement of existing therapies and for the development of new therapeutic approaches.
Detailed description
Recently new approaches to spinal cord repair have been successfully established in animal models. Promising therapies for promoting spinal axonal regeneration in man will be available in the near future. Most research in the field is focussed on the lesion itself and the perilesional spinal cord. The recovery of motor and sensory function is,however, not permitted by local processes at the spinal level only. The whole central nervous system (CNS) reacts to such a condition. Therefore the modulation of motor and sensory function in spinal cord lesioned patients should be reflected in characteristic changes of cortical brain activity, which are accessible to new non-invasive functional neuroimaging techniques such as functional magnetic resonance imaging (fMRI). Changes of white matter due to axonal damage can also be measured qualitatively and quantitatively using MR diffusion tensor imaging (DTI). Those measures may provide a basis to better understand the pathophysiology underlying spinal cord lesions in man, including changes in brain function over time (during rehabilitation) or related to specific treatment. However, there are no studies available yet addressing those topics or providing mechanism-based approaches for determining the time interval of application of novel neuroregenerative drugs. By investigation of brain activation and white matter changes in patients with congenital(myelomeningocele (MMC)), acute and chronic spinal cord lesions (ASIA A) first and fundamental work in this field will be conducted in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chronic posttraumatic paraplegia | – | Other: fMRI, DTIParaplegic patients (Thoracic level of lesion Th1-Th12), ASIA A, spinal cord injury (SCI) 12-24 months |
| Acute posttraumatic paraplegia | – | Other: fMRI, DTIParaplegic patients (Thoracic level of lesion Th1-Th12), ASIA A,SCI 2-6 months, |
| Myelomeningocele patients | – | Other: fMRI, DTIMyelomeningocele patients (congenital paraplegia, thoracic level of lesion Th1-Th12) ASIA A |
| Volunteers | – | Other: fMRI, DTIVolunteers without any neurological deficits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Paraplegic patients (Thoracic level of lesion Th1-Th12), ASIA A * Myelomeningocele patients (congenital paraplegia, thoracic level of lesion Th1-Th12) ASIA A * Volunteers without any neurological deficits
Key inclusion criteria (3 listed)
- Paraplegic patients (Th1-Th12, ASIA A),
- Myelomeningocele patients (Th1-Th12 ASIA A)
- Acute SCI 2-6 months, chronic SCI 12-24 months
Key exclusion criteria (5 listed)
- Traumatic brain injury (TBI)
- Neurological diseases other than spinal cord lesion
- MRI incompatibility
- Pressure sores
- methicillin-resistant Staphylococcus aureus (MRSA)
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 |
|---|---|---|
| fMRI, DTIfunctional magnetic resonance imaging (fMRI), MR diffusion tensor imaging (DTI) | Other | Acute posttraumatic paraplegia, Chronic posttraumatic paraplegia, Myelomeningocele patients, Volunteers |
Primary outcome
Not reported in the source record.
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 11 Mar 2015.
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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.
Christoph Stippich, Prof principal investigator
University Hospital, Basle - Department of Neuroradiology
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 Paraplegia, Spinal and Myelomeningocele, run by University Hospital, Basel, Switzerland 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 3 inclusion and 5 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 11 Mar 2015. 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.
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 11 Mar 2015.