Evaluation and Treatment of Neurosurgical Disorders

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

4 years - 99 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

5000 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

• 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

Study population

Subjects with a variety of neurosurgical disorders who require standard neurosurgical treatment; immediate blood relatives of those subjects in whom genetic testing is performed

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Study start

Jun 4, 2003 Actual

Primary completion

Not reported

Study completion

Not reported

First posted

May 7, 2003 Estimated

Last updated

Nov 10, 2026 Actual

Official study contacts