Evaluation and Treatment of Neurosurgical Disorders
2 other identifiers
observational
5,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2003
CompletedFirst Posted
Study publicly available on registry
May 7, 2003
CompletedStudy Start
First participant enrolled
June 4, 2003
CompletedApril 20, 2026
March 6, 2026
May 7, 2003
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
standard clinical evaluation and treatment
standard clinical evaluation and treatment
ongoing
Study Arms (1)
Patients
Patients age 4 or older seeking care from, or being referred to the Surgical Neurology Branch for evaluation and management of neurosurgical conditions
Interventions
Eligibility Criteria
Subjects with a variety of neurosurgical disorders who require standard neurosurgical treatment; immediate blood relatives of those subjects in whom genetic testing is performed
You may qualify if:
- Participants must be age 4 and older.
- 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)
- For adults: able to provide informed consent or having a legally-authorized representative to provide consent, if incapacitated
- For minors: a parent or legal guardian who is able to provide consent.
- For immediate blood relatives of subjects having genetic testing only:
- Blood relative of a subject who is suspected to have a genetic mechanism underlying their neurological disorder (for genetic testing only).
You may not qualify if:
- \. Patients who are unable to undergo evaluation and treatment for a neurosurgical disorder
- Participants must be age 4 and older.
- 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)
- For adults: able to provide informed consent or having a legally-authorized representative to provide consent, if incapacitated
- For minors: a parent or legal guardian who is able to provide consent.
- Be willing to consent for collection of clinical data or biological samples or their cryopreservation
- Patients who are unable to undergo evaluation and treatment for a neurosurgical disorder
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (6)
Curry BP, Alvarez R, Widemann BC, Johnson M, Agarwal PK, Lehky T, Valera V, Chittiboina P. Robotic Nerve Sheath Tumor Resection With Intraoperative Neuromonitoring: Case Series and Systematic Review. Oper Neurosurg. 2022 Feb 1;22(2):44-50. doi: 10.1227/ONS.0000000000000051.
PMID: 35007270DERIVEDBoyle J, Patronas NJ, Smirniotopoulos J, Herscovitch P, Dieckman W, Millo C, Maric D, Chatain GP, Hayes CP, Benzo S, Scott G, Edwards N, Ray Chaudhury A, Lodish MB, Sharma S, Nieman LK, Stratakis CA, Lonser RR, Chittiboina P. CRH stimulation improves 18F-FDG-PET detection of pituitary adenomas in Cushing's disease. Endocrine. 2019 Jul;65(1):155-165. doi: 10.1007/s12020-019-01944-7. Epub 2019 May 6.
PMID: 31062234DERIVEDSaldarriaga C, Lyssikatos C, Belyavskaya E, Keil M, Chittiboina P, Sinaii N, Stratakis CA, Lodish M. Postoperative Diabetes Insipidus and Hyponatremia in Children after Transsphenoidal Surgery for Adrenocorticotropin Hormone and Growth Hormone Secreting Adenomas. J Pediatr. 2018 Apr;195:169-174.e1. doi: 10.1016/j.jpeds.2017.11.042. Epub 2018 Feb 1.
PMID: 29395172DERIVEDChatain GP, Patronas N, Smirniotopoulos JG, Piazza M, Benzo S, Ray-Chaudhury A, Sharma S, Lodish M, Nieman L, Stratakis CA, Chittiboina P. Potential utility of FLAIR in MRI-negative Cushing's disease. J Neurosurg. 2018 Sep;129(3):620-628. doi: 10.3171/2017.4.JNS17234. Epub 2017 Oct 13.
PMID: 29027863DERIVEDLu J, Chatain GP, Bugarini A, Wang X, Maric D, Walbridge S, Zhuang Z, Chittiboina P. Histone Deacetylase Inhibitor SAHA Is a Promising Treatment of Cushing Disease. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2825-2835. doi: 10.1210/jc.2017-00464.
PMID: 28505327DERIVEDYong RL, Wu T, Mihatov N, Shen MJ, Brown MA, Zaghloul KA, Park GE, Park JK. Residual tumor volume and patient survival following reoperation for recurrent glioblastoma. J Neurosurg. 2014 Oct;121(4):802-9. doi: 10.3171/2014.6.JNS132038. Epub 2014 Jul 25.
PMID: 25061868DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John D Heiss, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2003
First Posted
May 7, 2003
Study Start
June 4, 2003
Last Updated
April 20, 2026
Record last verified: 2026-03-06
Data Sharing
- IPD Sharing
- Will not share
This study is not a clinical trial. This study design is not compatible with clinical data sharing.