Brain Function and White Matter Changes in Congenital, Acute and Chronic Spinal Cord Lesions
Recruitment status was Recruiting
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Purpose
The purpose of this study is to use functional MRI (fMRI) and 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Paraplegia, Spinal Myelomeningocele |
Other: fMRI, DTI |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Brain Function and White Matter Changes in Congenital, Acute and Chronic Spinal Cord Lesions |
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | January 2011 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Chronic posttraumatic paraplegia
Paraplegic patients (Thoracic level of lesion Th1-Th12), ASIA A, SCI 12-24 months
|
Other: fMRI, DTI
functional magnetic resonance imaging (fMRI), MR diffusion tensor imaging (DTI)
|
|
Acute posttraumatic paraplegia
Paraplegic patients (Thoracic level of lesion Th1-Th12), ASIA A,SCI 2-6 months,
|
Other: fMRI, DTI
functional magnetic resonance imaging (fMRI), MR diffusion tensor imaging (DTI)
|
|
Myelomeningocele patients
Myelomeningocele patients (congenital paraplegia, thoracic level of lesion Th1-Th12) ASIA A
|
Other: fMRI, DTI
functional magnetic resonance imaging (fMRI), MR diffusion tensor imaging (DTI)
|
|
Volunteers
Volunteers without any neurological deficits
|
Other: fMRI, DTI
functional magnetic resonance imaging (fMRI), MR diffusion tensor imaging (DTI)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
- 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
Inclusion criteria:
- Paraplegic patients (Th1-Th12, ASIA A),
- Myelomeningocele patients (Th1-Th12 ASIA A)
- Acute SCI 2-6 months, chronic SCI 12-24 months
Exclusion criteria:
- Traumatic brain injury (TBI)
- Neurological diseases other than spinal cord lesion
- MRI incompatibility
- Pressure sores
- MRSA
Contacts and Locations| Contact: Christoph Stippich, Prof | cstippich@uhbs.ch | |
| Contact: Magdalini Tozakidou, MD | mtozakidou@uhbs.ch |
| Switzerland | |
| University Hospital, Basle (only study site!) | Recruiting |
| Basle, Switzerland | |
| Contact: Christoph Stippich, Prof cstippich@uhbs.ch | |
| Principal Investigator: | Christoph Stippich, Prof | University Hospital, Basle - Department of Neuroradiology |
More Information
No publications provided
| Responsible Party: | University Hospital, Basel, Switzerland, Department of Neuroradiology, Professor Stippich |
| ClinicalTrials.gov Identifier: | NCT01208584 History of Changes |
| Other Study ID Numbers: | 306/09 |
| Study First Received: | September 23, 2010 |
| Last Updated: | December 6, 2010 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University Hospital, Basel, Switzerland:
|
functional MRI,primary motor cortex,spinal cord injury |
Additional relevant MeSH terms:
|
Meningomyelocele Paraplegia Neural Tube Defects Nervous System Malformations Nervous System Diseases |
Congenital Abnormalities Paralysis Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013