Evaluation and Treatment of Neurosurgical Disorders
|First Received Date ICMJE||May 7, 2003|
|Last Updated Date||July 31, 2014|
|Start Date ICMJE||May 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00060541 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Evaluation and Treatment of Neurosurgical Disorders|
|Official Title ICMJE||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.
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. 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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Neurologic Disorders|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||1600|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
1.Medically unstable or severe organ failure based on clinical evaluation.
|Ages||4 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00060541|
|Other Study ID Numbers ICMJE||030164, 03-N-0164|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP