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Prognostic Value of DTI and fMRI of Cervical Myelopathy (CSM)

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ClinicalTrials.gov Identifier: NCT03695848
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Brief Summary:
Cervical myelopathy (CM) is one of the most common degenerative spinal cord disorders affecting older people. The progression of CM is insidious and the neurological decline can vary between patients. Surgical decompression is considered the most effective way to treat CM, however, it is not free from risk and the surgical outcome is not always satisfactory. The expected outcome of surgical intervention for CM remains a difficulty. There is a pressing need for a reliable and quantitative approach to predict surgical outcomes of CM and the precise prognosis. Previous studies have suggested a number of prognostic factors, such as age, duration of symptoms, pre-operative neurological status and abnormal MRI, but their prognostic value remains controversial. Recently, diffusion tensor imaging (DTI) and fMRI have been proposed as a promising tool for predicting the surgical prognosis of CM. In previous study, the protocol was successfully established for DTI microstructural characterization and resting state fMRI of the cervical spinal cord. This study is to evaluate the value of DTI and fMRI in predicting the outcome of surgical treatment. The ultimate goal is to establish a clinical protocol for quantitative DTI and fMRI analysis that could give accurate prognosis for surgical intervention to CM.

Condition or disease Intervention/treatment
Cervical Myelopathy Device: MRI scan

Detailed Description:

Cervical myelopathy (CM) is the most common cause of spinal cord dysfunction in the elderly. Symptoms often develop insidiously and are characterized by neck stiffness, arm pain, numbness in the hands, and weakness of the hands and legs. The causes of this myelopathy are many, such as spinal canal narrowing, osteophytes, herniated discs and hypertrophy of the ligamentum flavum. Although the clinical signs and symptoms of CM are well documented in the literature, a precise localization of the maximum level of compression is sometimes difficult in the elderly patients where multiple levels of the cervical spine are degenerated. Also the lack of understanding of the pathophysiology and pathomechanism of CM has significantly hampered the development of a rational approach to the surgical treatment of such condition.

The diagnosis is made based on clinical signs and symptoms with the help of conventional MRI imaging which demonstrates the levels of anatomical stenosis. Surgical decompression of the cervical spine is the most common form of treatment. Magnetic resonance imaging (MRI) has been used widely in the evaluation of patients with CM. The commonly applied MR techniques include spin echo sequence, both conventional spin echo and fast/turbo spin echo for T1 and T2 information; gradient echo sequences, which generate T2 images; STIR (short tau inversion recovery) images; fat suppressed T1 images; gadolinium enhanced images applied to either routine T1WIs or fat suppressed T1WIs; MR spinal angiography; and cerebrospinal fluid flow (CSF) studies (either magnitude or phase contrast). However, conventional MRI mainly concerns anatomical information about CM, with less pathophysiological information. BOLD-fMRI is able to present the activated neuronal volume decreased in CM patients along with an increase in neuronal activities. diffusion tensor imaging (DTI) permits the detection of tissue-water molecular diffusion at microscopic dimensions. Previous studies have demonstrated the feasibility of DTI in evaluating microstructural changes in the myelopathic cervical cord. The prognostic values of spinal cord DTI in CM have been addressed in several previous studies. In recent years, combination of DTI and fMRI has been proposed to be an accurate prognostic tool for surgical management of CM.

Cervical myelopathy (CM) is caused by degenerative stenosis of the cervical spine with progressive compression on the spinal cord resulting in loss of sensory and motor functions in the upper and lower limbs. Surgical decompression of the cervical spine is the most common form of treatment.

The objective of this project is to evaluate the value of DTI and fMRI in predicting the outcome of surgical treatment.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prognostic Value of Diffusion Tensor Imaging and fMRI in Surgical Management of Cervical Myelopathy
Actual Study Start Date : September 26, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: MRI scan
    Before decompresssion surgery, DTI and fMRI will be recorded by a FDA approved 3T MRI scanner (Philips Achieva)


Primary Outcome Measures :
  1. postoperative neurological improvement rate [ Time Frame: Baseline on enrollment and 12 months follow-up ]
    comparison of clinical spinal cord functional changes between pre- and post-operative status.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with cervical myelopathy requiring surgical decompression will be recruited.
Criteria

Inclusion Criteria:

  • The inclusion criteria are a clinical diagnosis of CM including the signs of corticospinal lesions together with the appropriate radiographic findings.

Exclusion Criteria:

  • Patients with acute spinal cord injuries, prior spinal intervention, with shrapnel or other metal or electronic implants in their bodies (such as pacemakers, aneurysm clips, surgical devices, metallic tattoos on the head, etc.), with claustrophobia and pregnant women will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695848


Locations
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Hong Kong
G Li Recruiting
Hong Kong, Hong Kong
Contact: Y Hu, PhD    29740359    yhud@hotmail.com   
The university of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Guangsheng Li    852-29740336    guangshenglee@163.com   
Sponsors and Collaborators
The University of Hong Kong

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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03695848     History of Changes
Other Study ID Numbers: UW 18-394
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by The University of Hong Kong:
Cervical Myelopathy,Prognostication,Diffusion Tensor Imaging, fMRI

Additional relevant MeSH terms:
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Spinal Cord Diseases
Bone Marrow Diseases
Central Nervous System Diseases
Nervous System Diseases
Hematologic Diseases