Viewing Study NCT00447343



Ignite Creation Date: 2024-05-05 @ 5:23 PM
Last Modification Date: 2024-10-26 @ 9:31 AM
Study NCT ID: NCT00447343
Status: COMPLETED
Last Update Posted: 2017-08-28
First Post: 2007-03-13

Brief Title: Reorganization of Brain Functions in Patients With Cervical Myelopathy Using fMRI and MRS
Sponsor: Lawson Health Research Institute
Organization: Lawson Health Research Institute

Study Overview

Official Title: Mapping of the Sensorimotor Cortex in Cervical Myelopathy Using Functional Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy
Status: COMPLETED
Status Verified Date: 2017-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Decompressive surgery to relieve symptoms of spinal cord compression due to dysfunction such as arthritis has proved variable in success Past research has reported that approximately one-third of surgery patients improved one-third remained the same and one-third worsened Currently there are no reliable tests that can predict the outcome following surgery We are hoping that this study will change that

Using functional MRI fMRI we wish to investigate the relationship between clinical symptoms and the recovery of brain activation following surgery One can also track the concentrations of different chemicals metabolites by using magnetic resonance spectroscopy MRS We hypothesize that the recovery of normal brain activation patterns will coincide with clinical improvement Our objective in this study is to explore the potential role of fMRI as a tool to prognose patients with cervical myelopathy

Twenty-five patients with cervical myelopathy will be imaged using a high-powered 3 Tesla fMRI scanner before and six months following surgery In addition ten healthy controls will be imaged to provide a baseline measure Both the patient and control groups will complete questionnaires at the time of their scans These will provide information concerning the subjective experience of the individuals throughout recovery We will compare brain activation patterns of control and patient groups to investigate how the brain heals following decompressive surgery
Detailed Description: Degenerative arthritis is a universal concomitant of human aging affecting 51 of the adult population Arthritis of the spine is the most common cause of acquired spinal cord dysfunction and can manifest in subtle symptoms such as diminished balance and dexterity or profound symptoms such as paralysis and incontinence In cases where dysfunction results in severe spinal cord compression surgery is performed However surgical outcomes are not always beneficial Past research has reported that approximately one-third of surgery patients improved one-third remained the same and one-third worsened Currently there are no reliable tests that can predict outcome following surgery We are hoping that this study will change that

Twenty-five patients will undergo 45 minute imaging sessions pre-operatively and six months post-operatively Ten controls will undergo 45 minute imaging sessions twice to provide a baseline comparison and reproducibility During each session one motor task finger tapping and 1 sensory task hand brushing will be performed for 2 minutes at 10 second intervals We wish to compare the change in volume extent and location and intensity of brain activation levels before and after surgery We will also compare fMRI signal response differences between controls and patients We hypothesize that the degree to which brain activation shifts towards normalcy that of controls will correlate with the degree of neurological recovery postoperatively

Data will be analyzed using software developed at the Robarts Research Institute

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
09994 None None None