Evaluation and treatment of neurosurgical disorders
National Institutes of Health Clinical Center (CC) · NCT00060541
This study is testing how well standard evaluations and treatments work for people aged 4 and older with neurosurgical disorders like brain tumors, epilepsy, and Parkinson's disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 4 Years to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00060541 on ClinicalTrials.gov |
What this trial studies
This observational protocol aims to evaluate participants with neurosurgical disorders receiving care at the Surgical Neurology Branch. Participants aged 4 years and older will undergo standard clinical evaluations and treatments, which may include laboratory and radiological studies. Clinical data and samples collected during these evaluations will be utilized for research purposes, including potential genetic testing for those with suspected hereditary conditions. The study focuses on a range of neurologic disorders, including brain tumors, epilepsy, and Parkinson's disease.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 4 and older with neurosurgical-related conditions seeking care from the Surgical Neurology Branch.
Not a fit: Patients unable to undergo evaluation and treatment for a neurosurgical disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding and treatment of various neurosurgical disorders.
How similar studies have performed: Other studies focusing on similar neurosurgical evaluations have shown promise, indicating that this approach is grounded in established methodologies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: John D Heiss, M.D. — National Institute of Neurological Disorders and Stroke (NINDS)
- Study coordinator: Surgical Neurology Branch
- Email: snbrecruiting@nih.gov
- Phone: (301) 496-2921
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neurologic Disorders, Brain Tumor, Epilepsy, Pituitary Adenoma, Parkinson's Disease, Spinal Cord Tumor, Natural History