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Evaluation and Treatment of Neurosurgical Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00060541
Recruitment Status : Recruiting
First Posted : May 7, 2003
Last Update Posted : September 25, 2019
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief Summary:

This study offers evaluation and treatment of patients with a variety of neurological disorders that may require surgery. The protocol is not designed to test new treatments; rather, patients will receive standard care. The study is designed to: 1) allow NINDS s Surgical Neurology Branch staff to learn more about changes that cause nervous system disorders, 2) train physicians in the evaluation and treatment of these disorders; and 3) establish a pool of patients who may be eligible for other NINDS protocols. (Participants in this protocol will not be required to join another study; the decision will be voluntary.)

Patients of all ages with a disorder of the central nervous system (brain and spinal cord) or pituitary gland that may require surgery for diagnosis or treatment may be eligible for this study. In some cases surgery will not be needed. Candidates will be screened with a medical history and physical examination.

Participants may undergo tests, medial treatment, or surgical treatment to help diagnose or treat their condition. In most cases, care provided at the NIH will be limited to evaluation and surgery. Procedures may include laboratory tests, imaging tests, such as magnetic resonance imaging (MRI), computed tomography (CT) scans, angiograms, and other procedures to confirm the patient s diagnosis or help guide treatment. Patients who require surgery will be offered standard surgical care at NIH. Those whose procedure includes removal of tissues or fluids for diagnostic studies will be asked to allow a portion of the tissue to be used for research purposes, including analysis for gene and protein abnormalities that may be involved in causing the disorder or in influencing the patient s response to treatment. Blood samples will also be drawn for research.

Condition or disease
Neurologic Disorders

Detailed Description:

Objective: This protocol is designed to allow evaluation of participants with a variety of neurosurgical disorders for purposes of providing standard expert care and physician training.

Study Population: Participants 4 years of age and older with neurosurgical-related conditions are eligible for this protocol. The investigators will select participants based on the most appropriate needs for purposes of SNB and NINDS training.

Study Design: This is an observational study for training. Participants will receive standard evaluation and treatment for their condition. A physician, physician assistant, or nurse practitioner will obtain a medical history and perform a physical and neurological examination. 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. Tissue or blood samples removed during standard treatment, if not needed for care of the participant, may be used for research. Genetic testing may be performed on subjects and their blood relatives if a genetic mechanism underlying the neurological disorder is suspected.

Outcome Measures: No additional research outcome measures will be tracked in this study. All outcomes will be those of standard clinical evaluation and treatment.

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Study Type : Observational
Estimated Enrollment : 2500 participants
Official Title: Evaluation and Treatment of Neurosurgical Disorders
Study Start Date : May 6, 2003

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

    1. Age 4 and older.
    2. Neurosurgical-related conditions such as brain tumors, pituitary tumors, peripheral nerve tumors, epilepsy, Parkinson s disease, other abnormal movement disorders, arteriovenous malformations, and pain disorders, based on Surgical Neurology Branch training and teaching needs.
    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).


1.Medically unstable or severe organ failure based on clinical evaluation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00060541

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Contact: Gretchen C Scott, R.N. Not Listed

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: John D Heiss, M.D. National Institute of Neurological Disorders and Stroke (NINDS)

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS) Identifier: NCT00060541     History of Changes
Other Study ID Numbers: 030164
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: June 25, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Brain Tumor
Pituitary Adenoma
Parkinson's Disease
Vascular Malformation
Spinal Arteriovenous Malformation
Additional relevant MeSH terms:
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Nervous System Diseases
Pathologic Processes