NCT04055857

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 31, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 14, 2019

Status Verified

June 1, 2019

Enrollment Period

2.4 years

First QC Date

July 31, 2019

Last Update Submit

August 11, 2019

Conditions

Neuronal Intranuclear Inclusion Disease

Outcome Measures

Primary Outcomes (12)

  • fractional anisotropy (FA)

    Parameters to describe integrity of white matter in diffusion MR Imaging

    baseline

  • mean diffusivity (MD)

    Parameters to describe integrity of white matter in diffusion MR Imaging

    baseline

  • Intracellular volume fraction(icvf)

    Parameters to describe integrity of white matter in diffusion MR Imaging

    baseline

  • orientation dispersion index (ODI)

    Parameters to describe integrity of white matter in diffusion MR Imaging

    baseline

  • fiber number(fiber pass through the lesions)

    Parameters to describe integrity of white matter in diffusion MR Imaging

    baseline

  • fractional anisotropy (FA)

    Parameters to describe integrity of white matter in diffusion MR Imaging

    6 months

  • mean diffusivity (MD)

    Parameters to describe integrity of white matter in diffusion MR Imaging

    6 months

  • Intracellular volume fraction(icvf)

    Parameters to describe integrity of white matter in diffusion MR Imaging

    6 months

  • orientation dispersion index (ODI)

    Parameters to describe integrity of white matter in diffusion MR Imaging

    6 months

  • fiber number(fiber pass through the lesions)

    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

    Functional network connectivity impairments in patients

    baseline

  • short-range and long-range functional connectivity around the lesions at rest

    Functional network connectivity impairments in patients

    6 months

Study Arms (2)

NIID

NIID patients

HC

healthy control

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients diagnosed with NIID
  • Older than 18 years;
  • Sign the informed consent form.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siemens 7T MR

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Neuronal intranuclear inclusion disease

Study Officials

  • Ruiliang Bai, Doctor

    Zhejiang University Interdisciplinary Institute of Neuroscience and Technology (ZIINT)

    PRINCIPAL INVESTIGATOR

  • Hui Liang, Doctor

    Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Liang, Doctor

CONTACT

18757139736pushup@zju.edu.cn

Daqiang Ke, Bachelor

CONTACT

15658173819zhemuzhi@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 14, 2019

Study Start

July 31, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 14, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)