- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04955509
A Scar Recognition Software for Chronic Spinal Cord Injury (SCI)
In Vivo Optimization and Clinical Application of a Scar Recognition Software for Chronic Spinal Cord Injury (SCI)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Spinal cord injury (SCI) is a kind of serious neurologic damage caused by violence to the spinal cord, resulting in various functions of the body below the injury level, including motor, sensory, sphincter, and reflex dysfunction in varying degrees, usually resulting in permanent and irreversible functional loss or paralysis of patients. The treatment of SCI is an essential problem in the world. In the past decades, experimental research on SCI involves genes, proteins, cells, and tissues, and has made great progress. However, these studies mainly focus on the SCI at the early stage, rather than the later stage. The reason is that in the later stage, scar formed by glial cells and fibroblasts in the injured area is a physical and chemical barrier, which inhibits the regeneration and myelination of nerve axons and results in inhibiting spinal cord repairment. Therefore, before the treatment of chronic SCI, the key problem is to distinguish glial scar tissue from normal tissue and eliminate its influence.
As glial scar inhibits axon regeneration, eliminating glial scar is necessary for the repair of the injured spinal cord. In recent years, a large number of experimental studies have been carried out to destroy the process of glial scar formation after SCI by enzyme digestion and antibody. Though these methods reduced glial scar, residual glial scars were reported in animal experiments. Compared to biochemical methods, surgical resection of glial scar tissue is a relatively simple and effective method to eliminate glial scars. Due to the limited regeneration ability of nerves after SCI, it is important to identify scar tissue accurately before operations to avoid surgical injury to normal tissue, which is also the premise of further research and clinical application of various interventional treatment methods.
Magnetic resonance imaging (MRI) is one of the most commonly used non-invasive imaging techniques to evaluate the degree of injury and therapeutic effect of SCI. Nemours MRI studies on SCI show the impact of SCI on the central nervous system from the structural and functional level and prove the potential application value of MRI in assisting doctors in the diagnosis of SCI. A small number of previous studies have used magnetization transfer imaging, and diffusion tensor imaging to detect glial scar tissue, showing the potential application value of these images in differentiation between glial scar and surrounding normal spinal cord. However, because glial cells, which constitute glial scar, are also important components of normal spinal cord tissue, previous studies only identified glial scar from a single aspect, such as tissue type, macromolecular component, or water molecular diffusion strength. Therefore, their specificities were unsatisfactory. Relative methods were unable to identify glial scar accurately and finally resulted in difficulty in treatment arrangement and evaluation of prognosis, which hinders the development of SCI treatment research.
Combing multimodal MRI, including conventional MRI and diffusion MRI, with supervised machine learning makes accurate glial identification in chronic SCI possible. multimodal MRI can depict the differences between scar tissue and non-scar tissue from the aspects of cell composition, water molecular dispersion, structural complexity, etc. Comparing to MRI with a single model, multimodal MRI provides more specific features. Machine learning, a way to construct robust and accurate models, can mine the quantitative relationship between imaging features and clinical diagnosis results, reveal MRI feature markers of the glial scar, to improve the accuracy of identification. The research work, combined with medicine, imaging, and artificial intelligence technology, is expected to solve the problem of accurate and non-invasive identification of glial scar in chronic SCI, which has potential application value for laboratory research and clinical treatment of chronic SCI.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienkontakt
- Name: Mengze Zhang
- Telefonnummer: 18600393607
- E-Mail: zmzforever@pku.edu.cn
Studieren Sie die Kontaktsicherung
- Name: Ouyang Hanqiang
- E-Mail: ouyanghanqiang@bjmu.edu.cn
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- (Prospective part) compliance to MRI scan
- (Prospective part) no MRI contraindication
- (Retrospective part) available conventional MRI data
- clinical diagnosis of SCI (the course of disease≥1 year)
Exclusion Criteria:
- prior head or neck surgery or accompanying diseases with neurologic deficits and/or symptoms including multiple sclerosis, motor neuron disease, or spinal cord tumor
- images with motion artifact
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Sonstiges
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
Training
random splitting based on random sequences generated by engineers to train and optimize a machine learning model
|
conventional MRI and diffusion MRI
|
Testing
random splitting based on random sequences generated by engineers to evaluate the performance of the model
|
conventional MRI and diffusion MRI
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Performance of the fitted model
Zeitfenster: through study completion, an average of 2 year
|
positive predictive value (PPV)
|
through study completion, an average of 2 year
|
Performance of the fitted model
Zeitfenster: through study completion, an average of 2 year
|
sensitivity (SE)
|
through study completion, an average of 2 year
|
Performance of the fitted model
Zeitfenster: through study completion, an average of 2 year
|
Dice coefficient score (DSC)
|
through study completion, an average of 2 year
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Huishu Yuan, Peking University Third Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Voraussichtlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- M2020400,M2020356
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Rückenmarksverletzung
-
University of VersaillesBeendetZentrales Rückenmarksyndrom | Zentrales Cord Injury-SyndromFrankreich
-
Seoul National University HospitalAbgeschlossenUrologische Verschlechterung beim sekundären Tethered-Cord-Syndrom und Hinweise auf dessen ErkennungNeurogene Blasen | Tethered-Spinal-Cord-Syndrom
-
Guangzhou General Hospital of Guangzhou Military...UnbekanntKombinierte Spinal-EpiduralanästhesieChina
-
Adiyaman UniversityAbgeschlossenAuswirkungen der Spinal- und Epiduralanästhesie in der SchwangerschaftTruthahn
-
Instituto de Investigación Hospital Universitario...AbgeschlossenAuswirkungen der Spinal- und Epiduralanästhesie in der Schwangerschaft
-
Lawson Health Research InstituteAbgeschlossenEffekte von; Anästhesie, Spinal- und Epiduralanästhesie, in der Schwangerschaft
-
Region SkaneAbgeschlossenEffekte von; Anästhesie, Spinal- und Epiduralanästhesie, in der SchwangerschaftSchweden
-
University of MalayaUnbekanntEffekte von; Anästhesie, Spinal- und Epiduralanästhesie, in der SchwangerschaftMalaysia
-
Tel-Aviv Sourasky Medical CenterUnbekanntAspiration | Effekte von; Anästhesie, Spinal- und Epiduralanästhesie, in der SchwangerschaftIsrael
-
Beijing Chao Yang HospitalAbgeschlossenKombinierte Spinal-EpiduralanästhesieChina
Klinische Studien zur MRI
-
Assiut UniversityUnbekanntMultiple Sklerose
-
Vanderbilt UniversityNational Institutes of Health (NIH)ZurückgezogenHypoxische ischämische EnzephalopathieVereinigte Staaten
-
Fondation Ophtalmologique Adolphe de RothschildRekrutierungOptimierte MRT-SequenzenFrankreich
-
Institut National de la Santé Et de la Recherche...Abgeschlossen
-
University of MilanAbgeschlossenKnie-KnochenmarksläsionenItalien
-
Abbott Medical DevicesBeendet
-
London Health Sciences CentreAbgeschlossen
-
Fresenius Medical Care Deutschland GmbHAbgeschlossenHerz-Kreislauf-Erkrankungen | Nierenversagen | Angeborene StörungenVereinigtes Königreich
-
Central Hospital Saint QuentinUnbekanntAlzheimer ErkrankungFrankreich
-
Fondation LenvalAbgeschlossen