Clinical Value of DWI-ADC Matching in the Short-term Prognosis of Wilson's Disease

Not yet recruiting

• Conditions: Hepatolenticular Degeneration; Wilson

• Registration Number: NCT06196931
• Lead Sponsor: Hospital Affiliated to the Institute of Neurology, Anhui University of Chinese Medicine

Brief Summary

In earlier studies, it was found that patients of Wilson disease with new diagnosed who only has neurological symptoms often had DWI hyper-intensity in brain MRI, which was more common in putamen and midbrain, indicating that the disease was in the acute stage. However, many patients had ADC hyper-intensity or hypo-intensity at the same time, and the two different signals represented different disease processes from an imaging perspective. The former indicating T2 penetration effect, and the latter represents diffusion limitation, which indicating the presence of local inflammation, edema, etc. Whether the signal changes of these two different matching modes have guiding significance for the early de-copper treatment for WD, one is the core point of our study. We hope to exploring the predictive value about DWI-ACD signal matching for symptoms changes in the earlier time of de-copper treatment through this study.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-25
• Study First Submitted QC: 2023-12-25
• Last Update Submitted: 2023-12-25
• Study Start: 2024-01-01
• Study First Posted: 2024-01-09
• Last Update Posted: 2024-01-09
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients had been previously diagnosed with WD who both had DWI hyper-intensity and ADC hyper-intensity or hypo-intensity at the same time；
2. Patients who accept de-copper treatment in hospitalization for 4 weeks or more.

Exclusion Criteria

1. Patients who only with liver injury; 2. Severe complications;
2. Combined with other diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
UWDRS scales	Before and 4 weeks after treatment	It is used to evaluate the changes of patients' nervous system symptoms
24h urine copper	Before and 4 weeks after treatment	used to evaluate the changes of patients' nervous system symptoms

Secondary Outcome Measures

Name	Time	Method
ALT, AST and other liver function test	Before and 4 weeks after treatment	used to evaluate the changes of patients' nervous system symptoms
Semi-quantitative brain MRI score	Before de-copper treatment	It is used to evaluate the changes of patients' nervous system symptoms

Trial Locations

Locations (1)

The affiliated hospital of Institute of Neurology in Anhui University of Chinese Medicine; 🇨🇳 Hefei, Anhui, China