Neurologic DisordersNCT00060541
Evaluation and Treatment of Neurosurgical Disorders
An observational study of Neurologic Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 99 years
- Conditions the study is for
- Neurologic Disorders
- What is being tested?
- Laboratory tests and Radiological exams
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2003to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with a variety of neurosurgical disorders who require standard neurosurgical treatment; immediate blood relatives of those subjects in whom genetic testing is performed
Who may be able to join
- 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).
Who cannot join
- 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)
- 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.
Show all 10Show fewer
- 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)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Neurologic Disorders
- Being tested
- Laboratory tests, Radiological exams
- Keywords
- Brain Tumor, Epilepsy, Pituitary Adenoma, Parkinson's Disease, Spinal Cord Tumor, Natural History
- Medical subject headings
- Nervous System Diseases, Brain Neoplasms, Epilepsy, Pituitary Neoplasms, Parkinson Disease, Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory testsProcedure or surgery
Radiological examsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients age 4 or older who are seeking care from or being referred to the Surgical Neurology Branch for evaluation, and management of neurosurgical conditions Receives: Procedure: Laboratory tests; Procedure: Radiological exams |
What is being measured
The primary outcome is the main question the study is designed to answer.
standard clinical evaluation and treatment
standard clinical evaluation and treatment
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2003 (estimated)
- Study start4 Jun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Neurologic DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- John D Heiss, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060541
- Sponsor's protocol ID
- 030164
- Other IDs
- 03-N-0164
- Status last verified
- 17 Sep 2026
- First submitted
- 7 May 2003
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is not a clinical trial. This study design is not compatible with clinical data sharing.
Publications
Walker RL 3rd, Laws MT, Kim HJ, Zalewski C, Asthagiri A, Ranganathan S, Hayes C, Heiss JD, Butman JA, Chittiboina P. Intralabyrinthine MRI FLAIR as a predictive marker for hearing loss in vestibular schwannomas in Neurofibromatosis Type 2. J Neurooncol. 2026 Jan 26;176(3):182. doi: 10.1007/s11060-026-05422-9.
PubMed 41586863Curry 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.
PubMed 35007270Boyle 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.
PubMed 31062234Saldarriaga 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.
PubMed 29395172Chatain 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.
PubMed 29027863Lu 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.
PubMed 28505327Yong 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.
PubMed 25061868
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Treatment of Neurosurgical Disorders
- ClinicalTrials.gov ID
- NCT00060541
- Acronym / sponsor ID
- 030164
- Conditions
- Neurologic Disorders
- Keywords
- Brain Tumor, Epilepsy, Pituitary Adenoma, Parkinson's Disease, Spinal Cord Tumor, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 4 Jun 2003 (actual)
- First posted
- 7 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Laboratory tests, Procedure: Radiological examsPatients age 4 or older who are seeking care from or being referred to the Surgical Neurology Branch for evaluation, and management of neurosurgical conditions |
Who may qualify
- Ages
- 4 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with a variety of neurosurgical disorders who require standard neurosurgical treatment; immediate blood relatives of those subjects in whom genetic testing is performed
Key inclusion criteria (6 listed)
Key exclusion criteria (10 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory tests | Procedure or surgery | Patients |
| Radiological exams | Procedure or surgery | Patients |
Primary outcome
standard clinical evaluation and treatment
Time frame: ongoing
standard clinical evaluation and treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Derived from this study: PubMed 41586863Walker RL 3rd, Laws MT, Kim HJ, Zalewski C, Asthagiri A, Ranganathan S, Hayes C, Heiss JD, Butman JA, Chittiboina P. Intralabyrinthine MRI FLAIR as a predictive marker for hearing loss in vestibular schwannomas in Neurofibromatosis Type 2. J Neurooncol. 2026 Jan 26;176(3):182. doi: 10.1007/s11060-026-05422-9.
- Derived from this study: PubMed 35007270Curry 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.
- Derived from this study: PubMed 31062234Boyle 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.
- Derived from this study: PubMed 29395172Saldarriaga 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.
- Derived from this study: PubMed 29027863Chatain 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.
- Derived from this study: PubMed 28505327Lu 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.
- Derived from this study: PubMed 25061868Yong 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. This study is not a clinical trial. This study design is not compatible with clinical data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John D Heiss, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurologic Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Surgical Neurology Branch ((301) 496-2921, nindsdir-snbrecruiti@ninds.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
standard clinical evaluation and treatment (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00060541, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.