Clinical trial NCT04856839: Clinical Outcome in Patients With Syringomyelia（COPSM）
Official title: Phenotypes, Biomarkers and Pathophysiology in Syringomyelia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Syringomyelia/Hydromyelia
Keywords: Syringomyelia, Biomarker，Electrophysiology
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 200
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who was diagnosed as syringomyelia including: Chiari malformation、Basilar Impression、subarachnoid obstruction

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.

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.

Eligibility 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

Primary outcomes:
measure: Change of the spinal cord function
timeFrame: 1 day before operation and 3 days, 3 months, 12 months postoperation
Secondary outcomes:
measure: molecular profiling results
timeFrame: 1 day before operation and 3 days, 3 months postoperation
measure: Electrophysiology results
timeFrame: 1 day before operation and 3 days, 3 months postoperation
measure: the rates of syrinx reduction
timeFrame: 3 days, 3 months postoperation
measure: Chicago Chiari outcome scale (CCOS)
timeFrame: 3 days, 3 months, 12 months postoperation
measure: Visual Analog Scale (VAS)
timeFrame: 1 day before operation and 3 days, 3 months, 12 months postoperation
measure: Klekamp and Sammi syringomyelia scale
timeFrame: 1 day before operation and 3 days, 3 months, 12 months postoperation
measure: modified Japanese Orthopaedic Association Scores (mJOA)
timeFrame: 1 day before operation and 3 days, 3 months, 12 months postoperation
measure: Incidence of perioperative complications
timeFrame: 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Fengzeng Jian, M.D.
role: STUDY_DIRECTOR
References:
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