Evaluation and Treatment of Neurosurgical Disorders
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 4 - Any |
| Updated: | 3/31/2019 |
| Start Date: | May 6, 2003 |
| Contact: | Gretchen C Scott, R.N. |
| Email: | SNBrecruiting@nih.gov |
| Phone: | Not Listed |
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.
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 with a variety of
neurosurgical disorders for purposes of providing standard expert care and physician
training.
Study Population: Participants 4 years of age and older with neurosurgical-related conditions
are eligible for this protocol. The investigators will select participants based on the most
appropriate needs for purposes of SNB and NINDS training.
Study Design: This is an observational study for training. Participants 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 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. Tissue or blood samples removed during standard treatment, if not needed for
care of the participant, 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.
neurosurgical disorders for purposes of providing standard expert care and physician
training.
Study Population: Participants 4 years of age and older with neurosurgical-related conditions
are eligible for this protocol. The investigators will select participants based on the most
appropriate needs for purposes of SNB and NINDS training.
Study Design: This is an observational study for training. Participants 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 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. Tissue or blood samples removed during standard treatment, if not needed for
care of the participant, 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.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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