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: Completed
• Conditions: Healthy Volunteer; Nervous System Disease

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 (Actual): 3813

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

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	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

• 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): 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): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: November 7, 2025

More Information

Terms related to this study

• Keywords: Natural History; Healthy Volunteer; Nervous System Disease
• Additional Relevant MeSH Terms: Nervous System Diseases
• 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