Natural History Protocol for Movement Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson's Disease; Tremor; Movement Disorder

Detailed 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 Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Debra J Ehrlich, M.D.; Phone Number: (301) 443-7888; Email: debra.ehrlich@nih.gov
• Study Contact Backup: Name: Vivian S Koo; Phone Number: (301) 435-8518; Email: vivian.koo@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY dial 711 800-411-1222; Email: ccopr@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The following population groups may participate: - Subjects with neurological disorders who are 2 years old or older, - Family members who are 2 years old or older of people with a neurological disorder

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
family members; family members who are 2 years old or older of people with movement disorders
patients; subjects with movement disorders who are 2 years old or older

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Debra J Ehrlich, M.D., National Institute of Neurological Disorders and Stroke (NINDS)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 7, 2024

More Information

Terms related to this study

• Keywords: Natural History; Parkinson's Disease; Tremor; Movement Disorder
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Parkinson Disease; Movement Disorders; Tremor
• Other Study ID Numbers: 10000865; 000865-N

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No