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

NCT01208584 | Completed

• 1 other identifier: 306/09
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Paraplegia, Spinal; Myelomeningocele

Keywords

functional MRI,primary motor cortex,spinal cord injury

Study Arms (4)

Chronic posttraumatic paraplegia

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

Other: fMRI, DTI

Acute posttraumatic paraplegia

Paraplegic patients (Thoracic level of lesion Th1-Th12), ASIA A,SCI 2-6 months,

Other: fMRI, DTI

Myelomeningocele patients

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

Other: fMRI, DTI

Volunteers

Volunteers without any neurological deficits

Other: fMRI, DTI

Interventions

fMRI, DTI OTHER

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

Acute posttraumatic paraplegia; Chronic posttraumatic paraplegia; Myelomeningocele patients; Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Paraplegic patients (Th1-Th12, ASIA A),
• Myelomeningocele patients (Th1-Th12 ASIA A)
• Acute SCI 2-6 months, chronic SCI 12-24 months

You may not qualify if:

• Traumatic brain injury (TBI)
• Neurological diseases other than spinal cord lesion
• MRI incompatibility
• Pressure sores
• methicillin-resistant Staphylococcus aureus (MRSA)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Heidelberg University: collaborator

Study Sites (1)

University Hospital, Basle (only study site!)

Basel, Switzerland

Location

MeSH Terms

Conditions

Paraplegia; Meningomyelocele; Spinal Cord Injuries

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Christoph Stippich, Prof

  University Hospital, Basle - Department of Neuroradiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 24, 2010
• Study Start: August 1, 2008
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

CH (1)