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

NCT ID: NCT01208584

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2013-10-31

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.

Conditions

Paraplegia, Spinal; Myelomeningocele

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Chronic posttraumatic paraplegia

Paraplegic patients (Thoracic level of lesion Th1-Th12), ASIA A, spinal cord injury (SCI) 12-24 months

fMRI, DTI

Intervention Type: OTHER

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,

fMRI, DTI

Intervention Type: OTHER

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

Myelomeningocele patients

Myelomeningocele patients (congenital paraplegia, thoracic level of lesion Th1-Th12) ASIA A

fMRI, DTI

Intervention Type: OTHER

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

Volunteers

Volunteers without any neurological deficits

fMRI, DTI

Intervention Type: OTHER

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

Interventions

fMRI, DTI

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heidelberg University

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Stippich, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basle - Department of Neuroradiology

Locations

University Hospital, Basle (only study site!)

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

306/09

Identifier Type: -

Identifier Source: org_study_id