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Evaluation and Treatment of Neurosurgical Disorders

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
4 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 this research procedure."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects health information and samples during usual care for brain, spine, and nerve conditions that may need surgery. It is for people age 4 and older seeking care from or referred to the Surgical Neurology Branch. It does not test a new treatment; the information and samples may be used for future research.

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 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 this 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. ...

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 4 or older.
  • Seek care from or be referred to the Surgical Neurology Branch for a brain, spine, or nerve condition, such as tumors, epilepsy, movement problems, or pain.
  • Adults must be able to agree to join after learning about the study. If they cannot, a legally authorized person may agree for them.
  • Children must have a parent or legal guardian who can agree to their joining.
  • For genetic testing only: be a close blood relative of a participant whose nerve or brain condition may have an inherited cause.
  • For the group giving only skin or saliva samples: agree to collection of health information or body samples, or to freezing samples for storage.

Who can't join

  • Cannot undergo exams and treatment for a brain, spine, or nerve condition that may need surgery.
  • For the group giving only skin or saliva samples: at enrollment, do not have a clear diagnosis of a well-understood disease with proven treatment guidelines, and the study team believes using study resources would not help advance knowledge.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* 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

Study sites (1)

MD