💬In plain words
What the trial is, and whether it could suit you
Objective: This protocol is designed to allow the Surgical Neurology Branch to evaluate and treat the neurosurgical disorders of protocol participants. 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 part of this study.
Study Population: Participants 4 years of age and older with neurosurgical-related conditions, who are 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 treatm
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📋 Eligibility rules (as published)
* INCLUSION CRITERIA:
1. Participants must be age 4 and older.
2. Participants must seek care from, or be referred to the Surgical Neurology Branch for evaluation and management of neurosurgical conditions (such as central nervous system tumors, peripheral nerve tumors, epilepsy, Parkinson s disease, movement disorders, Chiari syndrome, central nervous system malformations, and pain disorders)
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\. Patients who are unable to undergo evaluation and treatment for a neurosurgical disorder
3.c. Participant Inclusion Criteria for the cohort with processing of biological samples only (for those subjects who are only having skin biopsies and/or saliva samples)
1. Participants must be age 4 and older.
2. Participants must seek care from or be referred to the Surgical Neurology Branch for evaluation and management of neurosurgical conditions (such as central nervous system tumors, peripheral nerve tumors, epilepsy, Parkinson s disease, movement disorders, Chiari syndrome, central nervous system malformations, and pain disorders)
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.
5. Be willing to consent for collection of clinical data or biological samples or their cryopreservation
3.D. Participant Exclusion Criteria for the cohort with processing of biological samples only (for those subjects who are only having skin biopsies and/or saliva samples)
1. Patients who are unable to undergo evaluation and treatment for a neurosurgical disorder
2. At the time of enrollment, subjects without an established diagnosis of a wellcharacterized disease entity with validated treatment algorithms. In such cases, proposed resource investment, in the opinion of the investigators, would not contribute to further advancement of knowledge
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