NCT00060541From ClinicalTrials.govRecruiting

Evaluation and Treatment of Neurosurgical Disorders

Neurologic Disorders

At a glance

Phase: Phase not stated
Study type: Observational
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Enrolment target: 5,000
Started: 4 June 2003
Main results due: Not stated
Study sites: 1
Registry updated: 29 September 2026

Can you take part?

Ages 4 years to 99 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

* INCLUSION CRITERIA:

1. Participants must be age 4 and older.
2. Participants must seek care from, or be referred to the Surgical Neurology Branch for evaluation and management of neurosurgical conditions (such as central nervous system tumors, peripheral nerve tumors, epilepsy, Parkinson s disease, movement disorders, Chiari syndrome, central nervous system malformations, and pain disorders)
3. For adults: able to provide informed consent or having a legally-authorized representative to provide consent, if incapacitated
4. For minors: a parent or legal guardian who is able to provide consent.

For immediate blood relatives of subjects having genetic testing only:
5. Blood relative of a subject who is suspected to have a genetic mechanism underlying their neurological disorder (for genetic testing only).

EXCLUSION CRITERIA:

1\. Patients who are unable to undergo evaluation and treatment for a neurosurgical disorder

3.c. Participant Inclusion Criteria for the cohort with processing of biological samples only (for those subjects who are only having skin biopsies and/or saliva samples)

1. Participants must be age 4 and older.
2. Participants must seek care from or be referred to the Surgical Neurology Branch for evaluation and management of neurosurgical conditions (such as central nervous system tumors, peripheral nerve tumors, epilepsy, Parkinson s disease, movement disorders, Chiari syndrome, central nervous system malformations, and pain disorders)
3. For adults: able to provide informed consent or having a legally-authorized representative to provide consent, if incapacitated
4. For minors: a parent or legal guardian who is able to provide consent.
5. Be willing to consent for collection of clinical data or biological samples or their cryopreservation

3.D. Participant Exclusion Criteria for the cohort with processing of biological samples only (for those subjects who are only having skin biopsies and/or saliva samples)

1. Patients who are unable to undergo evaluation and treatment for a neurosurgical disorder
2. At the time of enrollment, subjects without an established diagnosis of a wellcharacterized disease entity with validated treatment algorithms. In such cases, proposed resource investment, in the opinion of the investigators, would not contribute to further advancement of knowledge

What this study is about

In the sponsor’s own words, from the registry.

Objective: This protocol is designed to allow the Surgical Neurology Branch to evaluate and treat the neurosurgical disorders of protocol participants. The participants will receive standard-of-clinical-care evaluation and treatment. The clinical data and samples generated during standard of care treatment will be collected as part of this study.

Study Population: Participants 4 years of age and older with neurosurgical-related conditions, who are seeking care from or referred to the Surgical Neurology Branch for evaluation, are eligible for this protocol.

Study Design: This is an observational study. Participants will receive standard-of-clinical-care evaluation and treatment for their neurosurgical condition. Clinical evaluation may include laboratory and radiological studies designed to aid in diagnosis or differential diagnosis of the participant s condition or to facilitate treatment. The evaluations may take place in the outpatient clinic areas or in the inpatient units. Some participants will receive standard-of-care medical or surgical treatment for their disorder. Clinical data, tissue samples or body fluids obtained during standard of care treatment, may be used for research. Additional genetic testing may be performed on subjects and their blood relatives if a genetic mechanism underlying the neurological disorder is suspected. Patients in this study may choose to consent to skin biopsies for research purposes, in which case they will sign an additional consent document for this research procedure.

Outcome Measures: No additional research outcome measures will be tracked in this study, as this study is collecting data for potential future use. All outcomes will be those of standard clinical evaluation and treatment. A clinical and research database will be kept of patient s diagnosis, progression, and treatment. Clinical database information may be reported or be used in other studies.

Study sites(1)

National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT00060541. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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