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Evaluation and Treatment of Neurosurgical Disorders
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), February 2009
First Received: May 7, 2003   Last Updated: August 24, 2009   History of Changes
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00060541
  Purpose

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
Neurologic Disorders

Study Type: Observational
Official Title: Evaluation and Treatment of Neurosurgical Disorders

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1200
Study Start Date: May 2003
Estimated Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:

This protocol is designed to allow inpatient and outpatient evaluation of patients with a variety of neurosurgical disorders for purposes of providing standard expert care and physician training. In some cases, laboratory or radiological studies will be performed to confirm the diagnosis or to aid in the management of the patient, as would be done in current clinical practice. Some patients will receive medical or surgical treatment for their disorder. The purpose of performing these evaluations or treatments at the NIH is to support our clinical training mission. In patients in whom surgery is indicated as standard care for their condition, tissue samples may be collected at surgery and a portion of the specimen may be preserved for research. Blood samples may also be collected. These research samples will be stored in the tissue bank of the Surgical Neurology Branch.

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Subjects will be selected based on the teaching needs of the NINDS and the clinical and research interests of the investigators of the Surgical Neurology Branch.
    2. Patients 4 years of age and older with neurosurgical-related conditions will be eligible for this protocol. The investigators will make the selection of the patients based on the most appropriate needs for research or teaching purposes. Such studies may include but not be limited to brain tumors, pituitary tumors, epilepsy, Parkinson's disease, other abnormal movement disorders, arteriovenous malformations, and pain disorders.
    3. Informed consent from the patient, the patient's legal representative or the parent or legal guardian of a child under the age of 18 years.
    4. No racial or ethnic group or gender is excluded.

EXCLUSION CRITERIA:

  1. Medically unstable patients and patients with severe organ failure which may affect/limit the evaluation or therapy or exhaust Clinical Center and/or NINDS resources.
  2. For surgical candidates, medical conditions that cannot be corrected before surgery and which are standard contraindications to neurosurgery.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060541

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Additional Information:
No publications provided

Study ID Numbers: 030164, 03-N-0164
Study First Received: May 7, 2003
Last Updated: August 24, 2009
ClinicalTrials.gov Identifier: NCT00060541     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Brain Tumor
Epilepsy
Pituitary Adenoma
Parkinson's Disease
Vascular Malformation
Neurosurgery
Glioblastoma
Astrocytoma
Oligodendroglioma
Spinal Arteriovenous Malformation
Oncogenes
Proteomics
Neurological Disorder
Neurosurgical Condition

Additional relevant MeSH terms:
Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on November 25, 2009