Natural History Protocol for Movement Disorders

Parkinson's Disease Clinical Trial

Official title:

Natural History Protocol for Movement Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05413291
• Other study ID #: 10000865
• Secondary ID: 000865-N
• Status: Recruiting
• Start date: October 17, 2022
• Est. completion date: December 31, 2030

Study information

• Verified date: May 23, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Vivian S Koo
• Phone: (301) 435-8518
• Email: vivian.koo[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 100 Years

Eligibility

• INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Male or female, aged 2 and above

• Either one of these:

• Have or suspected to have a diagnosis of a movement disorder.

• Family member of someone who has or is suspected of having a diagnosis of a movement disorder.

• Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

An individual who meets the following criteria will be excluded from participation in this study:

-Being < 2 years old.

Related Conditions & MeSH terms

• Movement Disorder
• Movement Disorders
• Parkinson Disease
• Parkinson's Disease
• Tremor

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to screen patients with movement disorders and family members of patients with movement disorders for enrollment in additional research protocols	The goal is to screen patients with movement disorders and family members of patients with movement disorders for enrollment in additional research protocols. No investigational treatments will be administered on this protocol and the NIH physicians will be playing a consultative role to the patient s primary physician.	throughout protocol

External Links

•   NIH Clinical Center Detailed Web Page