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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 : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief Summary:

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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Condition or disease
Neurologic Disorders

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation and Treatment of Neurosurgical Disorders
Actual Study Start Date : June 4, 2003

Resource links provided by the National Library of Medicine


Group/Cohort
1
participants with a variety of neurosurgical disorders



Primary Outcome Measures :
  1. standard clinical evaluation and treatment [ Time Frame: ongoing ]
    standard clinical evaluation and treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria
  • INCLUSION CRITERIA:

    1. Age 4 and older.
    2. Neurosurgical-related conditions such as brain tumors, pituitary tumors, peripheral nerve 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.
    4. For minors: a parent or legal guardian who is able to provide consent.

      For immediate blood relatives of subjects having genetic testing only:

    5. Blood relative of a subject who is suspected to have a genetic mechanism underlying their neurological disorder (for genetic testing only).

EXCLUSION CRITERIA:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060541


Contacts
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Contact: Gretchen C Scott, R.N. Not Listed SNBrecruiting@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: John D Heiss, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00060541    
Other Study ID Numbers: 030164
03-N-0164
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: April 21, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Brain Tumor
Epilepsy
Pituitary Adenoma
Parkinson's Disease
Spinal Cord Tumor
Additional relevant MeSH terms:
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Nervous System Diseases