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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 : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Tracking Information
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
 (submitted: November 27, 2019)
standard clinical evaluation and treatment [ Time Frame: ongoing ]
standard clinical evaluation and treatment
Original Primary Outcome Measures Not Provided
Change History
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
 
Descriptive Information
Brief Title Evaluation and Treatment of Neurosurgical Disorders
Official Title Evaluation and Treatment of Neurosurgical Disorders
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.

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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen 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
Condition Neurologic Disorders
Intervention Not Provided
Study Groups/Cohorts 1
participants with a variety of neurosurgical disorders
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 11, 2020)
5000
Original Enrollment
 (submitted: June 23, 2005)
600
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Gretchen C Scott, R.N. Not Listed SNBrecruiting@nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00060541
Other Study ID Numbers 030164
03-N-0164
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)
Collaborators Not Provided
Investigators
Principal Investigator: John D Heiss, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date February 20, 2020