Evaluation and Treatment of Neurosurgical Disorders

Last updated: June 13, 2026
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Disorders

Epilepsy

Neurologic Disorders

Treatment

Laboratory tests

Radiological exams

Clinical Study ID

NCT00060541
030164
03-N-0164
  • Ages 4-99
  • All Genders

Study Summary

Objective: This protocol is designed to allow evaluation of participants neurosurgical disorders that receive care within the Surgical Neurology Branch. 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 a part of this study.

Study Population: Participants 4 years of age and older with neurosurgical-related conditions 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 thesethis 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.

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:

  1. Participants must be age 4 and older.

  2. Participants must seek care from, or be referred to the Surgical NeurologyBranch for evaluation and management of neurosurgical conditions (such ascentral nervous system tumors, peripheral nerve tumors, epilepsy, Parkinson sdisease, movement disorders, Chiari syndrome, central nervous systemmalformations, and pain disorders)

  3. For adults: able to provide informed consent or having a legally-authorizedrepresentative 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 mechanismunderlying their neurological disorder (for genetic testing only).

Exclusion

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 forevaluation and management of neurosurgical conditions (such as central nervoussystem tumors, peripheral nerve tumors, epilepsy, Parkinson s disease, movementdisorders, Chiari syndrome, central nervous system malformations, and paindisorders)

  3. For adults: able to provide informed consent or having a legally-authorizedrepresentative 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 theircryopreservation

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 neurosurgicaldisorder

  2. At the time of enrollment, subjects without an established diagnosis of awellcharacterized disease entity with validated treatment algorithms. In such cases,proposed resource investment, in the opinion of the investigators, would notcontribute to further advancement of knowledge

Study Design

Total Participants: 5000
Treatment Group(s): 2
Primary Treatment: Laboratory tests
Phase:
Study Start date:
June 04, 2003
Estimated Completion Date:

Study Description

Objective: This protocol is designed to allow evaluation of participants neurosurgical disorders that receive care within the Surgical Neurology Branch. 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 a part of this study.

Study Population: Participants 4 years of age and older with neurosurgical-related conditions 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 thesethis 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.

Connect with a study center

  • National Institutes of Health Clinical Center

    Bethesda, Maryland 20892
    United States

    Active - Recruiting

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