Evaluation and Treatment of Neurosurgical Disorders

This study is currently recruiting participants.
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00060541
First received: May 7, 2003
Last updated: March 14, 2014
Last verified: December 2013

May 7, 2003
March 14, 2014
May 2003
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Complete list of historical versions of study NCT00060541 on ClinicalTrials.gov Archive Site
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Evaluation and Treatment of Neurosurgical Disorders
Evaluation and Treatment of Neurosurgical Disorders

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.

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

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

Study Design: This is an observational study for training. Patients 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 patient s condition or to facilitate treatment. The evaluations may take place in the outpatient clinic areas or in the inpatient units. Some patients 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 patient, may be used for research.

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

Observational
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Neurologic Disorders
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1600
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  • INCLUSION CRITERIA:

    1. Age 4 and older.
    2. Neurosurgical-related conditions such as brain tumors, pituitary 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.

For minors: a parent or legal guardian who is able to provide consent.

EXCLUSION CRITERIA:

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

Both
4 Years and older
No
Contact: Gretchen C Scott, R.N. Not Listed SNBrecruiting@nih.gov
United States
 
NCT00060541
030164, 03-N-0164
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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)
National Institutes of Health Clinical Center (CC)
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP