Evaluating seizures in patients with brain tumors
Tumor Related Epilepsy
This study looks at how brain tumors that cause seizures affect people aged 8 and older, and whether surgery can help reduce those seizures and improve thinking skills.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 8 Years to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT02639325 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on individuals aged 8 and older who have brain tumors associated with seizures, known as tumor-related epilepsy. The research aims to evaluate the natural history of this condition and the impact of surgical treatment on seizure outcomes. Participants will undergo a thorough medical evaluation, including neurological exams and cognitive assessments, to gather data on their condition before and after surgery. The study also seeks to explore the relationship between tumor characteristics, surgical resection, and changes in seizure activity and cognitive function.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 8 and older with a confirmed diagnosis of a brain tumor and associated seizures.
Not a fit: Patients who do not have a brain tumor or those whose seizures are not related to a brain tumor may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced seizure frequency for patients with brain tumors.
How similar studies have performed: Other studies have shown promising results in surgical interventions for tumor-related epilepsy, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: To be eligible for entry into the study, a candidate must meet all the following criteria: * Be 8 years of age or older. * Have solitary primary or recurrent brain tumor with associated seizures. Brain tumor may be diagnosed radiologically. Associated seizures are defined as those with activity starting within three months of radiologic diagnosis of the primary or recurrent tumor. In cases when the timing of seizure activity is unclear with respect to the timing of diagnosis, seizures will be considered associated with the tumor if seizure semiology is consistent with that location. Ongoing seizures are not required. Patients can be included if they have had a single previous seizure. Patients who have not experienced seizures after institution of anti-convulsant therapy are not excluded. EXCLUSION CRITERIA: Candidates will be excluded if they: -At the time of enrollment, lack consent capacity due to cognitive impairment that would make them incapable of understanding the explanation of the procedures in this study. Cognitive capacity to consent will be determined at the time of enrollment. Patients with mental disorders or those patients who are cognitively impaired yet still retain consent capacity will not be excluded. Children may be enrolled if there is a parent or guardian able to consent on their behalf.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Kareem A Zaghloul, M.D. — National Institute of Neurological Disorders and Stroke (NINDS)
- Study coordinator: Gretchen C Scott, R.N.
- 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.