Protective Genetic Factors Against Neurological Diseases

Neurological Disorder Clinical Trial

Official title:

Protective Genetic Factors Against Neurological Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03914599
• Other study ID #: 08675309
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Healthy Control
• Nervous System Diseases
• Neurological Disorder

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