Evaluation and Treatment of Neurosurgical Disorders

This study is currently recruiting participants. (see Contacts and Locations)
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: July 31, 2014
Last verified: December 2013
  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
Neurologic Disorders

Study Type: Observational
Official Title: Evaluation and Treatment of Neurosurgical Disorders

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1600
Study Start Date: May 2003
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.
    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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060541

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

Locations
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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: John D Heiss, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00060541     History of Changes
Other Study ID Numbers: 030164, 03-N-0164
Study First Received: May 7, 2003
Last Updated: July 31, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Parkinson's Disease
Brain Tumor
Epilepsy
Pituitary Adenoma
Vascular Malformation
Neurosurgery
Glioblastoma
Astrocytoma
Oligodendroglioma
Spinal Arteriovenous Malformation
Oncogenes
Proteomics

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on August 27, 2014