Tremor Clinical Trial - Natural History Protocol for Movement Disorders

Status Recruiting

Clinical Trial Summary

Background: A movement disorder is a condition that causes a person s body to move in ways that are not normal. There are different types. Some disorders cause movements people can t control, such as tics or shaking. Some cause reduced or slow movements. Movement disorders can cause disability in people. Sometimes members of the same family will have the same disorder. Researchers want to learn more about how people develop these disorders. This research could lead to better treatments. Objective: This natural history study will collect data on people with different types of movement disorders. It will also collect data on their family members. The data will support further research. Eligibility: Children and adults aged 2 years and older who have a movement disorder. Family members of people with movement disorders are also needed. Design: Participants will undergo screening. They will have a physical exam. Researchers will look at their existing medical images. Any photographs or videos of their movements will also be reviewed. Most participants will come to the NIH clinic for only 1 visit. They will answer questions about their condition. They will have normal tests used to diagnose their condition. They may have blood tests and different types of imaging scans. They may have tests to see how well their nerves function. The tests used will depend on the type of disorder they have. Family members will have some of the same tests as people with disorders. Participants will not receive any new treatments. Some participants may be asked to return for a follow-up visit. Up to 4000 people may participate.

Clinical Trial Description

Study Description: This is a Natural History and Screening protocol for movement disorders, no research procedures will be done but the resulting data will be used for research. Objectives: Primary Objective: To collect data as part of standard of care evaluation of patients who have or are suspected to have a movement disorder and their family members for use in future secondary research. Endpoints: Collection of data from clinical/routine care that will contribute to/be used for future research. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05413291
Study type	Observational
Source	National Institutes of Health Clinical Center (CC)
Contact	Vivian S Koo
Phone	(301) 435-8518
Email	vivian.koo@nih.gov
Status	Recruiting
Phase
Start date	October 17, 2022
Completion date	December 31, 2030

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.