- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04055857
Structural and Functional Changes in Neuronal Intranuclear Inclusion Disease(NIID)
August 11, 2019 updated by: First Affiliated Hospital of Zhejiang University
Structural and Functional Changes in Neuronal Intranuclear Inclusion Disease: A Pioneer Multi-modal 7T MRI Observational Study.
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.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hui Liang, Doctor
- Phone Number: +86 18757139736
- Email: pushup@zju.edu.cn
Study Contact Backup
- Name: Daqiang Ke, Bachelor
- Phone Number: +86 15658173819
- Email: zhemuzhi@163.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310003
- Recruiting
- Siemens 7T MR
-
Contact:
- Ming Xiong
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects enrolled in the study shall be selected from NIID patients who are diagnosed with skin biopsy and gene detection.
The Investigator is responsible for screening potential subjects and selecting those who meet the eligibility criteria for the study as described.
Description
Inclusion Criteria:
- Patients diagnosed with NIID
- Older than 18 years;
- Sign the informed consent form.
Exclusion Criteria:
- The informed consent is withdrawn by the subject;
- Contraindications or intolerance to MRI: metallic foreign bodies, instability of vital signs, epilepsy, claustrophobia, etc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
NIID
NIID patients
|
HC
healthy control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fractional anisotropy (FA)
Time Frame: baseline
|
Parameters to describe integrity of white matter in diffusion MR Imaging
|
baseline
|
mean diffusivity (MD)
Time Frame: baseline
|
Parameters to describe integrity of white matter in diffusion MR Imaging
|
baseline
|
Intracellular volume fraction(icvf)
Time Frame: baseline
|
Parameters to describe integrity of white matter in diffusion MR Imaging
|
baseline
|
orientation dispersion index (ODI)
Time Frame: baseline
|
Parameters to describe integrity of white matter in diffusion MR Imaging
|
baseline
|
fiber number(fiber pass through the lesions)
Time Frame: baseline
|
Parameters to describe integrity of white matter in diffusion MR Imaging
|
baseline
|
fractional anisotropy (FA)
Time Frame: 6 months
|
Parameters to describe integrity of white matter in diffusion MR Imaging
|
6 months
|
mean diffusivity (MD)
Time Frame: 6 months
|
Parameters to describe integrity of white matter in diffusion MR Imaging
|
6 months
|
Intracellular volume fraction(icvf)
Time Frame: 6 months
|
Parameters to describe integrity of white matter in diffusion MR Imaging
|
6 months
|
orientation dispersion index (ODI)
Time Frame: 6 months
|
Parameters to describe integrity of white matter in diffusion MR Imaging
|
6 months
|
fiber number(fiber pass through the lesions)
Time Frame: 6 months
|
Parameters to describe integrity of white matter in diffusion MR Imaging
|
6 months
|
short-range and long-range functional connectivity around the lesions at rest
Time Frame: baseline
|
Functional network connectivity impairments in patients
|
baseline
|
short-range and long-range functional connectivity around the lesions at rest
Time Frame: 6 months
|
Functional network connectivity impairments in patients
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ruiliang Bai, Doctor, Zhejiang University Interdisciplinary Institute of Neuroscience and Technology (ZIINT)
- Principal Investigator: Hui Liang, Doctor, Zhejiang University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2018
Primary Completion (Anticipated)
December 31, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
July 31, 2019
First Submitted That Met QC Criteria
August 11, 2019
First Posted (Actual)
August 14, 2019
Study Record Updates
Last Update Posted (Actual)
August 14, 2019
Last Update Submitted That Met QC Criteria
August 11, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7TMRINIID
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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