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Clinical Outcome in Patients With Syringomyelia（COPSM）

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04856839
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : June 8, 2021
Sponsor:
Information provided by (Responsible Party):
Fengzeng Jian, Xuanwu Hospital, Beijing

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of this study is to determine the clinical spectrum and natural progression of Syringomyelia (SM) and related disorders in a prospective single center study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the etiology and molecular mechanisms of these diseases.

Condition or disease Intervention/treatment
Syringomyelia/Hydromyelia Diagnostic Test: high throughput sequencing and electromyography

Detailed Description:

Syringomyelia is a chronic central spinal cord injury, which is characterized by dilation of the central canal of the spinal cord. At present, the treatment of syringomyelia is mainly through surgical decompression to restore the disturbance of cerebrospinal fluid circulation. Due to the heterogeneity of the etiology of syringomyelia, almost all published studies on the clinical outcome and prognostic factors of syringomyelia are relatively limited, and most of them are retrospective. It is not clear which is the most reliable predictor of clinical outcome. Therefore, the researchers conducted this prospective cohort study to identify the occurrence, development and outcome of syringomyelia and determine the main prognostic factors through clinical scales, biomarkers and electrophysiology.

At study visits a standardized clinical examination will be performed including application of clinical rating scales. At all study visits, patients will be asked to donate biosamples; biomaterial collection is optional and participants can elect to participate in sampling of blood, urine, CSF, and/or a muscle biopsy.

Optionally, additional examinations may be performed including imaging, neurophysiological examination, analysis of patient or observer reported outcomes and analysis to characterize molecular biomarkers.

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phenotypes, Biomarkers and Pathophysiology in Syringomyelia
Actual Study Start Date : April 16, 2021
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
syringomyelia group Diagnostic Test: high throughput sequencing and electromyography
Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics
Other neurodegenerative diseases
such as hydrocephalus
 Diagnostic Test: high throughput sequencing and electromyography
Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics
Normal group Diagnostic Test: high throughput sequencing and electromyography
Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics


Outcome Measures
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Primary Outcome Measures :
  1. Change of the spinal cord function [ Time Frame: 1 day before operation and 3 days, 3 months, 12 months postoperation ]
    American Spinal Injury Association(ASIA) Score for evaluating the spinal cord function


Secondary Outcome Measures :
  1. molecular profiling results [ Time Frame: 1 day before operation and 3 days, 3 months postoperation ]
    Change From Baseline in molecular at postoperation

  2. Electrophysiology results [ Time Frame: 1 day before operation and 3 days, 3 months postoperation ]
    included：electromyography and evoked potential; Change From Baseline in Electrophysiology at postoperation

  3. the rates of syrinx reduction [ Time Frame: 3 days, 3 months postoperation ]
    defined as a reduction of the syrinx diameter or length in MRI

  4. Chicago Chiari outcome scale (CCOS) [ Time Frame: 3 days, 3 months, 12 months postoperation ]
    Pain symptoms,Nonpain symptoms,Functionality,Complications, 4-16, higher scores mean a better outcome.

  5. Visual Analog Scale (VAS) [ Time Frame: 1 day before operation and 3 days, 3 months, 12 months postoperation ]
    degree of the pain, 1-10, higher scores mean a worse outcome

  6. Klekamp and Sammi syringomyelia scale [ Time Frame: 1 day before operation and 3 days, 3 months, 12 months postoperation ]
    for evaluating the spinal cord function, higher scores mean a better outcome

  7. modified Japanese Orthopaedic Association Scores (mJOA) [ Time Frame: 1 day before operation and 3 days, 3 months, 12 months postoperation ]
    Motor function， sensory， bladder function；for evaluating the spinal cord function；0-17， higher scores mean a better outcome

  8. Incidence of perioperative complications [ Time Frame: 1 week ]

Biospecimen Retention:   Samples With DNA
Blood, cerebral spinal fluid, saliva, urine, biopsy and autopsy

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients who was diagnosed as syringomyelia including: Chiari malformation、Basilar Impression、subarachnoid obstruction
Criteria

Inclusion Criteria:

  • patients who was diagnosed as syringomyelia including: Chiari malformation， Basilar Impression， subarachnoid obstruction， patient not received surgical or interventional treatment before， patient willing and able to participate in the registry，
  • Hydrocephalus or other neurodegenerative disease and normal subjects.

Exclusion Criteria:

  • patient received surgical treatment or interventional treatment before
  • patient is pregnant
  • patient unable to complete follow-up
  • patient with other spinal lesions
  • other nervous system diseases
Contacts and Locations
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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): NCT04856839


Contacts
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Contact: Fengzeng Jian, M.D. +8613552067268 jianfengzeng@xwh.ccmu.edu.cn
Contact: chenghua yuan +8617777784396 yuanchenghua2@163.com

Locations
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China, Beijing
Xuanwu Hospital Recruiting
Beijing, Beijing, China, 100032
Contact: fengzeng jian         
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
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Study Director: Fengzeng Jian, M.D. Xuanwu Hospital, Beijing
More Information
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Publications:
CreveCoeur TS, Yahanda AT, Maher CO, Johnson GW, Ackerman LL, Adelson PD, Ahmed R, Albert GW, Aldana PR, Alden TD, Anderson RCE, Baird L, Bauer DF, Bierbrauer KS, Brockmeyer DL, Chern JJ, Couture DE, Daniels DJ, Dauser RC, Durham SR, Ellenbogen RG, Eskandari R, Fuchs HE, George TM, Grant GA, Graupman PC, Greene S, Greenfield JP, Gross NL, Guillaume DJ, Haller G, Hankinson TC, Heuer GG, Iantosca M, Iskandar BJ, Jackson EM, Jea AH, Johnston JM, Keating RF, Kelly MP, Khan N, Krieger MD, Leonard JR, Mangano FT, Mapstone TB, McComb JG, Menezes AH, Muhlbauer M, Oakes WJ, Olavarria G, O'Neill BR, Park TS, Ragheb J, Selden NR, Shah MN, Shannon C, Shimony JS, Smith J, Smyth MD, Stone SSD, Strahle JM, Tamber MS, Torner JC, Tuite GF, Wait SD, Wellons JC, Whitehead WE, Limbrick DD. Occipital-Cervical Fusion and Ventral Decompression in the Surgical Management of Chiari-1 Malformation and Syringomyelia: Analysis of Data From the Park-Reeves Syringomyelia Research Consortium. Neurosurgery. 2021 Jan 13;88(2):332-341. doi: 10.1093/neuros/nyaa460.

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Responsible Party: Fengzeng Jian, director of neurospine department, Xuanwu hospital, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT04856839    
Other Study ID Numbers: XWCOPSM
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fengzeng Jian, Xuanwu Hospital, Beijing:
Syringomyelia, Biomarker，Electrophysiology
Additional relevant MeSH terms:
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Syringomyelia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases