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OpenTrials
Completed

NCT Number: NCT03914599

Protective Genetic Factors Against Neurological Diseases

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.

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Key information

Conditions

Neurological Disorder Healthy Control Nervous System Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wayne State University

Detroit, Michigan, 48201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of a neurological disorder - Inherited Peripheral Neuropathy, Charcot Marie Tooth, Multiple Sclerosis, or Parkinson's Disease
  • Healthy volunteers with no history of medical conditions known to afflict the nervous system will be recruited as normal controls.
  • Age 18-100 (Inclusive)
  • Able to undergo MRI
  • Medically Stable

Exclusion criteria

  • Any subject unwilling to undergo genetic testing (DNA sampling)
  • 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.

Treatment and study plan

Primary outcomes

  1. Association of human genetic variants with the fastest conduction speed in normal controls

    Time frame: 5 years

    nerve conduction velocity as measured by electromyogram machine

  2. 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

    Time frame: 5 years

    nerve conduction velocity and neurological disability scores as assessed by Visser Neuropathy Score ranging from 0-68 with higher score indicating more severe disabilities.

  3. To test if the genetic variants associated with the fastest CV in the PNS protect some patients with CMT1A from developing severe disabilities

    Time frame: 5 years

    neurological disability scores as assessed by Visser Neuropathy Score ranging from 0-68 with higher score indicating more severe disabilities.

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 16, 2019
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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