Structural and Functional Changes in Neuronal Intranuclear Inclusion Disease(NIID)

• Conditions: Neuronal Intranuclear Inclusion Disease

• Registration Number: NCT04055857
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

To discover the microstructure, macrostructure and functional changes with 7T multi-modal magnetic resonance imaging of Neuronal Intranuclear Inclusion Disease, and to explore new biomarkers for evaluating the severity and the progression of Neuronal Intranuclear Inclusion Disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-31
• Status Verified: 2019-06
• Study First Submitted: 2019-07-31
• Study First Submitted QC: 2019-08-11
• Last Update Submitted: 2019-08-11
• Study First Posted: 2019-08-14
• Last Update Posted: 2019-08-14
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients diagnosed with NIID
2. Older than 18 years;
3. Sign the informed consent form.

Exclusion Criteria

1. The informed consent is withdrawn by the subject;
2. Contraindications or intolerance to MRI: metallic foreign bodies, instability of vital signs, epilepsy, claustrophobia, etc.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fractional anisotropy (FA)	6 months	Parameters to describe integrity of white matter in diffusion MR Imaging
fiber number(fiber pass through the lesions)	6 months	Parameters to describe integrity of white matter in diffusion MR Imaging
Intracellular volume fraction(icvf)	6 months	Parameters to describe integrity of white matter in diffusion MR Imaging
mean diffusivity (MD)	6 months	Parameters to describe integrity of white matter in diffusion MR Imaging
orientation dispersion index (ODI)	6 months	Parameters to describe integrity of white matter in diffusion MR Imaging
short-range and long-range functional connectivity around the lesions at rest	6 months	Functional network connectivity impairments in patients

Trial Locations

Locations (1)

Siemens 7T MR; 🇨🇳 Hangzhou, Zhejiang, China