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.|
|ClinicalTrials.gov Identifier: NCT00060541|
Recruitment Status : Recruiting
First Posted : May 7, 2003
Last Update Posted : February 24, 2020
|First Submitted Date||May 7, 2003|
|First Posted Date||May 7, 2003|
|Last Update Posted Date||February 24, 2020|
|Actual Study Start Date||June 4, 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||standard clinical evaluation and treatment [ Time Frame: ongoing ]
standard clinical evaluation and treatment
|Original Primary Outcome Measures||Not Provided|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Evaluation and Treatment of Neurosurgical Disorders|
|Official Title||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 participants neurosurgical disorders that receive care within the Surgical Neurology Branch. The participants will receive standard-of-clinical-care evaluation and treatment. The clinical data and samples generated during standard of care treatment will be collected as a part of this study.
Study Population: Participants 4 years of age and older with neurosurgical-related conditions seeking care from, or referred to the Surgical Neurology Branch for evaluation are eligible for this protocol.
Study Design: This is an observational study. Participants will receive standard-of- clinical-care evaluation and treatment for their neurosurgical condition. 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. Clinical data, tissue samples or body fluids obtained during standard of care treatment, may be used for research. Additional 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, as this study is collecting data for potential future use. All outcomes will be those of standard clinical evaluation and treatment. A clinical and research database will be kept of patient s diagnosis, progression, and treatment. Clinical database information may be reported or be used in other studies.
|Study Design||Observational Model: Case-Only
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||Subjects with a variety of neurosurgical disorders who require standard neurosurgical treatment; immediate blood relatives of those subjects in whom genetic testing is performed|
participants with a variety of neurosurgical disorders
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
1.Medically unstable or severe organ failure based on clinical evaluation.
|Ages||4 Years and older (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||030164
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )|
|Study Sponsor||National Institute of Neurological Disorders and Stroke (NINDS)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 20, 2020|