Clinical trial NCT01208584: Brain Function and White Matter Changes in Congenital, Acute and Chronic Spinal Cord Lesions
Official title: Brain Function and White Matter Changes in Congenital, Acute and Chronic Spinal Cord Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paraplegia, Spinal
Myelomeningocele
Keywords: functional MRI,primary motor cortex,spinal cord injury
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Heidelberg University
First posted: 2010-09-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.

Eligibility criteria: 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
* methicillin-resistant Staphylococcus aureus (MRSA)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basle
country: Switzerland
facility: University Hospital, Basle (only study site!)
Study officials:
affiliation: University Hospital, Basle - Department of Neuroradiology
name: Christoph Stippich, Prof
role: PRINCIPAL_INVESTIGATOR
References: