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Evaluation and Treatment of Neurosurgical Disorders - Article


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Developmental Disabilities & Disorders

Developmental Disabilities




Clinical Trial: Evaluation and Treatment of Neurosurgical Disorders

This study is currently recruiting patients.

Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: Warren G Magnuson Clinical Center (CC)

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 Treatment or Intervention
Neurologic Disorders
 Procedure: Laboratory tests
 Procedure: Radiological exams

MedlinePlus related topics:  Neurologic Diseases

Study Type: Interventional
Study Design: Training

Further Study Details: 

Expected Total Enrollment:  600

Study start: May 5, 2003

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

Genders Eligible for Study:  Both

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 of all ages 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.

Location and Contact Information


Maryland
      National Institute of Neurological Disorders and Stroke (NINDS), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting
Patient Recruitment and Public Liaison Office  1-800-411-1222    prpl@mail.cc.nih.gov 
TTY  1-866-411-1010 

More Information

Detailed Web Page

Study ID Numbers:  030164; 03-N-0164
Record last reviewed:  February 24, 2004
Last Updated:  January 28, 2005
Record first received:  May 7, 2003
ClinicalTrials.gov Identifier:  NCT00060541
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 4, 2008



Page Updated: September 6, 2005
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