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Clinical Outcome in Patients With Syringomyelia(COPSM)

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Capital Medical University

Status

Enrolling

Conditions

Syringomyelia/Hydromyelia

Treatments

Diagnostic Test: high throughput sequencing and electromyography

Study type

Observational

Funder types

Other

Identifiers

NCT04856839
XWCOPSM

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

Under 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

200 participants in 3 patient groups

syringomyelia group
Treatment:
Diagnostic Test: high throughput sequencing and electromyography
Other neurodegenerative diseases
Description:
such as hydrocephalus
Treatment:
Diagnostic Test: high throughput sequencing and electromyography
Normal group
Treatment:
Diagnostic Test: high throughput sequencing and electromyography

Trial contacts and locations

1

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Central trial contact

Fengzeng Jian, M.D.; chenghua yuan

Data sourced from clinicaltrials.gov

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