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Completed

NCT Number: NCT01208584

Brain Function and White Matter Changes in Congenital, Acute and Chronic Spinal Cord Lesions

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

fMRI, DTI

Other

functional magnetic resonance imaging (fMRI), MR diffusion tensor imaging (DTI)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Heidelberg University

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Sep 24, 2010
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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