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.

Study Overview

• Status: Completed
• Conditions: Myelomeningocele; Paraplegia, Spinal
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• Switzerland
  • Basle, Switzerland
    • University Hospital, Basle (only study site!)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Heidelberg University
• Investigators: Principal Investigator: Christoph Stippich, Prof, University Hospital, Basle - Department of Neuroradiology

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: September 23, 2010
• First Submitted That Met QC Criteria: September 23, 2010
• First Posted (Estimate): September 24, 2010

Study Record Updates

• Last Update Posted (Estimate): March 11, 2015
• Last Update Submitted That Met QC Criteria: March 10, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: functional MRI,primary motor cortex,spinal cord injury
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Congenital Abnormalities; Nervous System Malformations; Paralysis; Neural Tube Defects; Spinal Dysraphism; Meningomyelocele; Spina Bifida Cystica; Paraplegia
• Other Study ID Numbers: 306/09