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

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT01208584
Collaborator
Heidelberg University (Other)
22
Enrollment
1
Location
62
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: fMRI, 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.

Study Design

Study Type:
Observational
Actual Enrollment :
22 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Brain Function and White Matter Changes in Congenital, Acute and Chronic Spinal Cord Lesions
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Oct 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT01208584
    Other Study ID Numbers:
    • 306/09
    First Posted:
    Sep 24, 2010
    Last Update Posted:
    Mar 11, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by University Hospital, Basel, Switzerland
    functional MRI,primary motor cortex,spinal cord injury
    Additional relevant MeSH terms:
    Paraplegia
    Meningomyelocele
    Spina Bifida Cystica

    Study Results

    No Results Posted as of Mar 11, 2015