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Trial record 4 of 8 for:    "Myelomeningocele"

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Heidelberg University
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01208584
First received: September 23, 2010
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


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

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Estimated Enrollment: 60
Study Start Date: August 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chronic posttraumatic paraplegia
Paraplegic patients (Thoracic level of lesion Th1-Th12), ASIA A, spinal cord injury (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
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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208584

Locations
Switzerland
University Hospital, Basle (only study site!)
Basle, Switzerland
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Heidelberg University
Investigators
Principal Investigator: Christoph Stippich, Prof University Hospital, Basle - Department of Neuroradiology
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01208584     History of Changes
Other Study ID Numbers: 306/09
Study First Received: September 23, 2010
Last Updated: February 10, 2014
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
Congenital Abnormalities
Nervous System Diseases
Nervous System Malformations
Neural Tube Defects
Neurologic Manifestations
Paralysis
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014