Diagnosis and History Study of Patients With Different Neurological Conditions

Diagnosis and Natural History Protocol for Patients With Different Neurological Conditions

This protocol is a screening and natural history protocol, which allows for evaluation of

patients and families where neurological conditions are present for enrollment into other

studies and will also be used to screen healthy volunteers to create a pool of potential future HV matches for HMCS protocols. Through diagnostic evaluations, data will be collected for research use in this study.

Study Overview

Status

Recruiting

Detailed Description

This protocol is a screening and natural history protocol, which allows for evaluation of

patients and families where neurological conditions are present for enrollment into other

studies and will also be used to screen healthy volunteers to create a pool of potential future HV matches for HMCS protocols. Through diagnostic evaluations, data will be collected for research use in this study.

Study Type

Observational

Enrollment (Estimated)

4100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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, - Healthy volunteers who are 18 years old or older.

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
family members
Family Members who are 2 years old or older of people with a neurological disorder
healthy volunteers
healthy volunteers age 18 and older
patients
subjects with neurological 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 neurological conditions and family members of patients with neurological conditions for enrollment in additional research protocols
Time Frame: ongoing
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.
ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 1993

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (Estimated)

November 4, 1999

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

February 7, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 930202
  • 93-N-0202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

.This protocol was written before creating sharing plans was required. We do share data with other protocols done by our group to avoid having to repeat procedures, but there is no official "research" done in this protocol, so it is unlikely that we will need to share any IPD elsewhere. If there is, we will consider it on a case-by-case basis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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