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Diagnosis and History Study of Patients With Different Neurological Conditions

This study is currently recruiting participants.
Verified November 2, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001367
First Posted: November 4, 1999
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
  Purpose

The goal of this study is to diagnose and follow patients with disorders of movement control. Patients participating in this study will undergo routine laboratory tests and examinations in order to monitor their condition.

Doctors at the NIH will work in cooperation with each patient's primary care physician. There will be no use of investigational treatments in this study.<TAB>


Condition
Nervous System Disease

Study Type: Observational
Official Title: Diagnosis and Natural History Protocol for Patients With Different Neurological Conditions

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):

Estimated Enrollment: 4100
Study Start Date: September 1, 1993
Detailed Description:

Objective:

This protocol is a screening protocol, which allows for evaluation of patients and families where neurological conditions are present for enrollment into other studies. It is also a teaching and training instrument for the MNB fellows, allowing them to gain expertise in the evaluation and treatment of patients. Finally, it will be used to screen healthy volunteers to create a pool of potential future HV matches for HMCS protocols.

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
  • Healthy volunteers who are 18 years old or older.
  • National Institutes of Health (NIH) employees (other than those employed by HMCS in NINDS) may participate.

Design:

The goal is to screen patients with neurological conditions and family members of patients with neurological conditions 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.

We will also screen healthy volunteers to create a pool of potential future HV matches for other HMCS protocols.

Outcome measures:

This is a natural history screening protocol to evaluate patients with neurological disorders and their family members, and to screen healthy volunteers for to create a pool of potential future HV matches other HMCS protocols. Therefore, there is no outcome measure.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • Patients with neurological disorders and subjects with a family history of neurological conditions OR
  • Healthy volunteers: People age 18 or older who are generally in good health.

EXCLUSION CRITERIA:

  • Patients <2 years old.
  • Employees of HMCS in NINDS.

EXCLUSION CRITERIA FOR MRI (patients and family members only):

We will follow the Clinical Radiology/NMR Center guidelines for MR safety. Some of the exclusions are:

  • Have non-MRI compatible metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or metal fragments in the eye as these make having an MRI unsafe.
  • Have metallic dental fillings which are likely to cause MRI artifacts
  • Unable to lie flat on the back for the expected length of the experiment, up to 30 mins.
  • Uncomfortable being in a small space for the expected length of the experiment, up to 30 mins.
  • Pregnancy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001367


Contacts
Contact: Elaine P Considine, R.N. (301) 435-8518 considinee@ninds.nih.gov
Contact: Mark Hallett, M.D. (301) 496-9526 hallettm@ninds.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Mark Hallett, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00001367     History of Changes
Other Study ID Numbers: 930202
93-N-0202
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: November 7, 2017
Last Verified: November 2, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Human
Movement
Non-Investigational to Diagnostic Puzzle
Parkinson's
Dystonia
Cerebellar
Puzzles
Neurological Disorders
Movement Disorders

Additional relevant MeSH terms:
Nervous System Diseases