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

Neuronal Intranuclear Inclusion Disease Clinical Trial

Official title:

Structural and Functional Changes in Neuronal Intranuclear Inclusion Disease: A Pioneer Multi-modal 7T MRI Observational Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04055857
• Other study ID #: 7TMRINIID
• Status: Recruiting
• Start date: July 31, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2019
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Hui Liang, Doctor
• Phone: 18757139736
• Email: pushup[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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 The informed consent is withdrawn by the subject;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.

Related Conditions & MeSH terms

• Neurodegenerative Diseases
• Neuronal Intranuclear Inclusion Disease

Locations

Country	Name	City	State
China	Siemens 7T MR	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University	Zhejiang University Interdisciplinary Institute of Neuroscience and Technology

Country where clinical trial is conducted

China, 

Outcome

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