Syringomyelia/HydromyeliaNCT04856839
Clinical Outcome in Patients With Syringomyelia（COPSM）
An observational study of Syringomyelia/Hydromyelia, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Syringomyelia/Hydromyelia
- What is being tested?
- high throughput sequencing and electromyography
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2021to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients who was diagnosed as syringomyelia including: Chiari malformation、Basilar Impression、subarachnoid obstruction
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital
Beijing, Beijing Municipality, 100032
fengzeng jian
About this study
Official title: Phenotypes, Biomarkers and Pathophysiology in Syringomyelia
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.
Read the 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.
- Conditions
- Syringomyelia/Hydromyelia
- Being tested
- high throughput sequencing and electromyography
- Keywords
- Syringomyelia, Biomarker，Electrophysiology
- Medical subject headings
- Syringomyelia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high throughput sequencing and electromyographyDiagnostic test
Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics
| Study group | Role | What they receive |
|---|---|---|
| syringomyelia group | Not described Receives: Diagnostic Test: high throughput sequencing and electromyography | |
| Other neurodegenerative diseases | such as hydrocephalus Receives: Diagnostic Test: high throughput sequencing and electromyography | |
| Normal group | Not described Receives: Diagnostic Test: high throughput sequencing and electromyography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the spinal cord function
American Spinal Injury Association(ASIA) Score for evaluating the spinal cord function
Measured: 1 day before operation and 3 days, 3 months, 12 months postoperation
Secondary outcomes (8)
molecular profiling results
Change From Baseline in molecular at postoperation
Measured: 1 day before operation and 3 days, 3 months postoperation
Electrophysiology results
included：electromyography and evoked potential; Change From Baseline in Electrophysiology at postoperation
Measured: 1 day before operation and 3 days, 3 months postoperation
the rates of syrinx reduction
defined as a reduction of the syrinx diameter or length in MRI
Measured: 3 days, 3 months postoperation
Chicago Chiari outcome scale (CCOS)
Pain symptoms,Nonpain symptoms,Functionality,Complications, 4-16, higher scores mean a better outcome.
Measured: 3 days, 3 months, 12 months postoperation
Visual Analog Scale (VAS)
degree of the pain, 1-10, higher scores mean a worse outcome
Measured: 1 day before operation and 3 days, 3 months, 12 months postoperation
Klekamp and Sammi syringomyelia scale
for evaluating the spinal cord function, higher scores mean a better outcome
Measured: 1 day before operation and 3 days, 3 months, 12 months postoperation
modified Japanese Orthopaedic Association Scores (mJOA)
Motor function， sensory， bladder function；for evaluating the spinal cord function；0-17， higher scores mean a better outcome
Measured: 1 day before operation and 3 days, 3 months, 12 months postoperation
Incidence of perioperative complications
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start16 Apr 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Syringomyelia/HydromyeliaStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengzeng Jian, Xuanwu Hospital, Beijing
- Investigators
- Fengzeng Jian, M.D., Study director, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856839
- Sponsor's protocol ID
- XWCOPSM
- Status last verified
- Jun 2021
- First submitted
- 17 Apr 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33313928Nakajima M, Rauramaa T, Makinen PM, Hiltunen M, Herukka SK, Kokki M, Musialowicz T, Jyrkkanen HK, Danner N, Junkkari A, Koivisto AM, Jaaskelainen JE, Miyajima M, Ogino I, Furuta A, Akiba C, Kawamura K, Kamohara C, Sugano H, Tange Y, Karagiozov K, Leinonen V, Arai H. Protein tyrosine phosphatase receptor type Q in cerebrospinal fluid reflects ependymal cell dysfunction and is a potential biomarker for adult chronic hydrocephalus. Eur J Neurol. 2021 Feb;28(2):389-400. doi: 10.1111/ene.14575. Epub 2020 Nov 1.
PubMed 33035386Klekamp J. Surgical treatment of Chiari I malformation--analysis of intraoperative findings, complications, and outcome for 371 foramen magnum decompressions. Neurosurgery. 2012 Aug;71(2):365-80; discussion 380. doi: 10.1227/NEU.0b013e31825c3426.
PubMed 22569058Roser F, Ebner FH, Liebsch M, Dietz K, Tatagiba M. A new concept in the electrophysiological evaluation of syringomyelia. J Neurosurg Spine. 2008 Jun;8(6):517-23. doi: 10.3171/SPI/2008/8/6/517.
PubMed 18518671Sadler B, Wilborn J, Antunes L, Kuensting T, Hale AT, Gannon SR, McCall K, Cruchaga C, Harms M, Voisin N, Reymond A, Cappuccio G, Brunetti-Pierri N, Tartaglia M, Niceta M, Leoni C, Zampino G, Ashley-Koch A, Urbizu A, Garrett ME, Soldano K, Macaya A, Conrad D, Strahle J, Dobbs MB, Turner TN, Shannon CN, Brockmeyer D, Limbrick DD, Gurnett CA, Haller G. Rare and de novo coding variants in chromodomain genes in Chiari I malformation. Am J Hum Genet. 2021 Mar 4;108(3):530-531. doi: 10.1016/j.ajhg.2021.01.014. No abstract available.
PubMed 33667397Guan J, Yuan C, Zhang C, Ma L, Yao Q, Cheng L, Liu Z, Wang K, Duan W, Wang X, Wang Z, Wu H, Chen Z, Jian F. A novel classification and its clinical significance in Chiari I malformation with syringomyelia based on high-resolution MRI. Eur Spine J. 2021 Jun;30(6):1623-1634. doi: 10.1007/s00586-021-06746-y. Epub 2021 Feb 5.
PubMed 33544223
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypes, Biomarkers and Pathophysiology in Syringomyelia
- ClinicalTrials.gov ID
- NCT04856839
- Acronym / sponsor ID
- XWCOPSM
- Conditions
- Syringomyelia/Hydromyelia
- Keywords
- Syringomyelia, Biomarker，Electrophysiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| syringomyelia group | – | Diagnostic Test: high throughput sequencing and electromyography |
| Other neurodegenerative diseases | – | Diagnostic Test: high throughput sequencing and electromyographysuch as hydrocephalus |
| Normal group | – | Diagnostic Test: high throughput sequencing and electromyography |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who was diagnosed as syringomyelia including: Chiari malformation、Basilar Impression、subarachnoid obstruction
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high throughput sequencing and electromyographyWhole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics | Diagnostic test | Normal group, Other neurodegenerative diseases, syringomyelia group |
Primary outcome
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
8 secondary outcomes
molecular profiling results
Time frame: 1 day before operation and 3 days, 3 months postoperation
Electrophysiology results
Time frame: 1 day before operation and 3 days, 3 months postoperation
the rates of syrinx reduction
Time frame: 3 days, 3 months postoperation
Chicago Chiari outcome scale (CCOS)
Time frame: 3 days, 3 months, 12 months postoperation
Visual Analog Scale (VAS)
Time frame: 1 day before operation and 3 days, 3 months, 12 months postoperation
Klekamp and Sammi syringomyelia scale
Time frame: 1 day before operation and 3 days, 3 months, 12 months postoperation
modified Japanese Orthopaedic Association Scores (mJOA)
Time frame: 1 day before operation and 3 days, 3 months, 12 months postoperation
Incidence of perioperative complications
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Background: PubMed 33313928CreveCoeur 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.
- Background: PubMed 33035386Nakajima M, Rauramaa T, Makinen PM, Hiltunen M, Herukka SK, Kokki M, Musialowicz T, Jyrkkanen HK, Danner N, Junkkari A, Koivisto AM, Jaaskelainen JE, Miyajima M, Ogino I, Furuta A, Akiba C, Kawamura K, Kamohara C, Sugano H, Tange Y, Karagiozov K, Leinonen V, Arai H. Protein tyrosine phosphatase receptor type Q in cerebrospinal fluid reflects ependymal cell dysfunction and is a potential biomarker for adult chronic hydrocephalus. Eur J Neurol. 2021 Feb;28(2):389-400. doi: 10.1111/ene.14575. Epub 2020 Nov 1.
- Background: PubMed 22569058Klekamp J. Surgical treatment of Chiari I malformation--analysis of intraoperative findings, complications, and outcome for 371 foramen magnum decompressions. Neurosurgery. 2012 Aug;71(2):365-80; discussion 380. doi: 10.1227/NEU.0b013e31825c3426.
- Background: PubMed 18518671Roser F, Ebner FH, Liebsch M, Dietz K, Tatagiba M. A new concept in the electrophysiological evaluation of syringomyelia. J Neurosurg Spine. 2008 Jun;8(6):517-23. doi: 10.3171/SPI/2008/8/6/517.
- Background: PubMed 33667397Sadler B, Wilborn J, Antunes L, Kuensting T, Hale AT, Gannon SR, McCall K, Cruchaga C, Harms M, Voisin N, Reymond A, Cappuccio G, Brunetti-Pierri N, Tartaglia M, Niceta M, Leoni C, Zampino G, Ashley-Koch A, Urbizu A, Garrett ME, Soldano K, Macaya A, Conrad D, Strahle J, Dobbs MB, Turner TN, Shannon CN, Brockmeyer D, Limbrick DD, Gurnett CA, Haller G. Rare and de novo coding variants in chromodomain genes in Chiari I malformation. Am J Hum Genet. 2021 Mar 4;108(3):530-531. doi: 10.1016/j.ajhg.2021.01.014. No abstract available.
- Background: PubMed 33544223Guan J, Yuan C, Zhang C, Ma L, Yao Q, Cheng L, Liu Z, Wang K, Duan W, Wang X, Wang Z, Wu H, Chen Z, Jian F. A novel classification and its clinical significance in Chiari I malformation with syringomyelia based on high-resolution MRI. Eur Spine J. 2021 Jun;30(6):1623-1634. doi: 10.1007/s00586-021-06746-y. Epub 2021 Feb 5.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fengzeng Jian, M.D. study director
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syringomyelia/Hydromyelia, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fengzeng Jian, M.D. (+8613552067268, jianfengzeng@xwh.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the spinal cord function (time frame: 1 day before operation and 3 days, 3 months, 12 months postoperation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04856839, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.