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

Myelomeningocele Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01208584
• Other study ID #: 306/09
• Status: Completed
• Phase: Phase 4
• First received: September 23, 2010
• Last updated: March 10, 2015
• Start date: August 2008
• Est. completion date: October 2013

Study information

• Verified date: March 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Meningomyelocele
• Myelomeningocele
• Paraplegia
• Paraplegia, Spinal

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital, Basle (only study site!)	Basle

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Heidelberg University

Country where clinical trial is conducted

Switzerland,