Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060541
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2003-05-07
Brief Title:
Evaluation and Treatment of Neurosurgical Disorders
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation and Treatment of Neurosurgical Disorders
Status:
RECRUITING
Status Verified Date:
2024-09-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Patients in this study may choose to consent to skin biopsies for research purposes in which case they will sign an additional consent document for thesethis research procedure
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 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 Patients in this study may choose to consent to skin biopsies for research purposes in which case they will sign an additional consent document for thesethis research procedure
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
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 Patients in this study may choose to consent to skin biopsies for research purposes in which case they will sign an additional consent document for thesethis research procedure
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 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 Patients in this study may choose to consent to skin biopsies for research purposes in which case they will sign an additional consent document for thesethis research procedure
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-N-0164 | None | None | None |