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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03914599
Other study ID # 08675309
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2019
Est. completion date July 11, 2022

Study information

Verified date July 2022
Source Wayne State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

NIH Precision Medicine Initiative, started in May 2018, will enroll one million people through an online portal. It hopes to identify genetic variants affecting a variety of human phenotypic outcomes. A giant set of data like this may enable an association of genetic variants with a certain phenotype. However, the association is often compromised due to the collection of phenotypic data that is not well controlled or standardized creating "noisy" data. These phenotypic "noises" can be largely eliminated in clinical studies with stringent criteria and standardization of outcome measurements. In this study, by looking mainly at genetic information and nerve conduction speed, we hope to eliminate the extra "noises" in the data set. Eliminating the extra "noises" should allow us to be able to determine if there are genetic differences between neurological disorders and healthy controls, and if these genetic differences can be attributed to the speed of the nerve conduction.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date July 11, 2022
Est. primary completion date July 11, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: 1. Diagnosis of a neurological disorder - Inherited Peripheral Neuropathy, Charcot Marie Tooth, Multiple Sclerosis, or Parkinson's Disease 2. Healthy volunteers with no history of medical conditions known to afflict the nervous system will be recruited as normal controls. 3. Age 18-100 (Inclusive) 4. Able to undergo MRI 5. Medically Stable Exclusion Criteria: 1. Any subject unwilling to undergo genetic testing (DNA sampling) 2. Any subjects with history of peripheral nerve diseases or conditions known to affect the CNS, such as diabetes, stroke, thyroid disease, chemotherapy, renal failure, etc. Note: This study holds no additional risk for pregnant women and they will not be excluded.

Study Design


Locations

Country Name City State
United States Wayne State University Detroit Michigan

Sponsors (1)

Lead Sponsor Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Association of human genetic variants with the fastest conduction speed in normal controls nerve conduction velocity as measured by electromyogram machine 5 years
Primary The cluster of genetic variants associated with the fastest conduction velocity in normal controls versus those altered in patients with neurological diseases will be characterized nerve conduction velocity and neurological disability scores as assessed by Visser Neuropathy Score ranging from 0-68 with higher score indicating more severe disabilities. 5 years
Primary To test if the genetic variants associated with the fastest CV in the PNS protect some patients with CMT1A from developing severe disabilities neurological disability scores as assessed by Visser Neuropathy Score ranging from 0-68 with higher score indicating more severe disabilities. 5 years
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