Machine Learning Diagnosis and Prediction for Cervical Myelopathy

NCT05099627 | Unknown

• 1 other identifier: 21SM7167
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

DESIGN: Ambispective cohort study (retrospective + prospective). AIMS: The overall aim of this research study is to create two predictive machine learning models that are based on radiological, clinical and biochemical variables, which allows spine surgeons to diagnose CSM earlier and more accurately, as well as allowing them to give patients highly individualised and accurate predictive information regarding treatment outcomes. OUTCOME MEASURES: For the prospective arm of the study the independent variables will be patient characteristics, clinical, radiological and biochemical markers. Dependent variables are mJOA and JOACMEQ scores. For the retrospective arm of the study the independent variables will be patient characteristics, co-morbidities and symptomology, outcome variable will be radiological confirmation on cervical myelopathy. POPULATION: Patients with cervical myelopathy over 18 years old (19 years and above included), treated at Imperial College NHS Healthcare Trust for CM with full capacity to consent and assessed for cervical myelopathy symptoms at Community MSK Hounslow and Richmond Community Healthcare NHS Trust (catchment area of ICHT neurosurgery). ELIGIBILITY: Over 18 years old, with full capacity to consent. TREATMENT: Cervical myelopathy diagnosis and/or conservative and/or surgical management of disease DURATION: 18 months

Conditions

Cervical Myelopathy

Outcome Measures

Primary Outcomes (5)

• JOACMEQ questionnaire

  For prospective arm.

  31 October 2021 till 31 October 2022

• mJOA questionnaire

  For prospective arm.

  31 October 2021 till 31 October 2022

• "Cervical myelopathy treatment outcome questionnaire"

  For prospective arm. The will be measured using physical examination, taking a medical history, questionnaire results and data extraction from medical records. There will be no invasive interventions added by this study.

  31 October 2021 till 31 October 2022

• "CSM early diagnosis questionnaire"

  For retrospective arm. See attached questionnaire.

  31 October 2021 - 31 October 2019 (retrospective)

• Nurick score

  For retrospective arm. Using the patients radiological imaging data, diagnosis yielded using the Nurick Score.

  31 October 2021 - 31 October 2019 (retrospective)

Secondary Outcomes (1)

• DOR (diagnostic odds ratio)

  31 October 2022 till 31 December 2022

Study Arms (2)

Prospective cohort study arm

The questionnaire "Cervical myelopathy treatment outcome questionnaire" attached records information relating to co-morbidities and symptomology. The examination will be a thorough neurological examination in addition to a focused cardiovascular examination. Biochemical blood markers from existing blood markers or from GP records, which have been or would have been performed regardless of this trial. Radiological findings will be taken from routine MRI and cervical spine X-rays performed as part of the CSM diagnostic work-up. The mJOA score and JOACMEQ score are the outcome measures for the prospective arm of the study. Good response to surgery is a 1-point improvement in mJOA score at 3 and 6 months.

Other: The questionnaire "Cervical myelopathy treatment outcome questionnaire"; Other: JOACMEQ questionnaire and mJOA

Retrospective cohort study arm

The retrospective questionnaire "CSM early diagnosis questionnaire" contains all the questions which will be collected retrospectively via telephone. Furthermore patients from the community MSK team, those diagnosed with CM eventually and those examined for CM query, their clinical, biochemical and radiological data from the local SystemOne Databases will be collected for analysis and comparison. Radiological confirmation of cervical myelopathy is the outcome measure for the retrospective arm.

Other: The retrospective questionnaire "CSM early diagnosis questionnaire"

Interventions

The questionnaire "Cervical myelopathy treatment outcome questionnaire" OTHER

Information gathered through clinical examination and questionnaires performed retrospectively over the phone, pre-operation and at 3- and 6-months post-operation. The questionnaire "Cervical myelopathy treatment outcome questionnaire" attached records information relating to co-morbidities and symptomology. The examination will be a thorough neurological examination in addition to a focused cardiovascular examination. Biochemical blood markers from existing blood markers or from GP records, which have been or would have been performed regardless of this trial. Radiological findings will be taken from routine MRI and cervical spine X-rays performed as part of the CSM diagnostic work-up

Prospective cohort study arm

The retrospective questionnaire "CSM early diagnosis questionnaire" OTHER

To identify early clinical predictors of cervical myelopathy diagnosis based on individual patient-reported symptoms by using a questionnaire and patient characteristics as well as co-morbities, as well as clinical examination findings provided by community musculoskeletal teams.

Retrospective cohort study arm

JOACMEQ questionnaire and mJOA OTHER

Used for prospective cohort via telephone at 3, 6 and 12-months post-operatively to assess treatment outcomes.

Prospective cohort study arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Over 18 years old. Patients with cervical myelopathy over 18 years old (19 years and above included), treated at Imperial College NHS Healthcare Trust for CM with full capacity to consent and assessed for cervical myelopathy symptoms at Community MSK Hounslow and Richmond Community Healthcare NHS Trust (catchment area of ICHT neurosurgery).Full capacity to consent.

You may qualify if:

• Over 18 years old. Treated at Imperial College NHS Healthcare Trust and/or Community MSK Hounslow and Richmond Community Healthcare NHS Trust for cervical myelopathy.
• Full capacity to consent.

You may not qualify if:

• Children and adolescents. Patients with HIV, CJD and Hepatitis.

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Related Publications (4)

• Baron EM, Young WF. Cervical spondylotic myelopathy: a brief review of its pathophysiology, clinical course, and diagnosis. Neurosurgery. 2007 Jan;60(1 Supp1 1):S35-41. doi: 10.1227/01.NEU.0000215383.64386.82.

  PMID: 17204884 RESULT

• Hopkins BS, Weber KA 2nd, Kesavabhotla K, Paliwal M, Cantrell DR, Smith ZA. Machine Learning for the Prediction of Cervical Spondylotic Myelopathy: A Post Hoc Pilot Study of 28 Participants. World Neurosurg. 2019 Jul;127:e436-e442. doi: 10.1016/j.wneu.2019.03.165. Epub 2019 Mar 25.

  PMID: 30922901 RESULT

• Merali ZG, Witiw CD, Badhiwala JH, Wilson JR, Fehlings MG. Using a machine learning approach to predict outcome after surgery for degenerative cervical myelopathy. PLoS One. 2019 Apr 4;14(4):e0215133. doi: 10.1371/journal.pone.0215133. eCollection 2019.

  PMID: 30947300 RESULT

• Merali Z, Wang JZ, Badhiwala JH, Witiw CD, Wilson JR, Fehlings MG. A deep learning model for detection of cervical spinal cord compression in MRI scans. Sci Rep. 2021 May 18;11(1):10473. doi: 10.1038/s41598-021-89848-3.

  PMID: 34006910 RESULT

Study Officials

• Santhosh G. Thavarajasingam, BSc

  Imperial College London

  STUDY DIRECTOR

• Mahmoud El-Khatib, BSc

  Imperial College London

  STUDY CHAIR

• Mark Rea, BSc

  Imperial College London

  STUDY CHAIR

• Diana Keeling, BSc Msc

  Community MSK Hounslow and Richmond Community Healthcare NHS Trust

  STUDY CHAIR

Central Study Contacts

Salvatore Russo, FRCS

CONTACT

+44 7883088997; salvatore.russo@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 29, 2021
• Study Start: October 31, 2021
• Primary Completion: May 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share