An observational study in Epilepsy, Cancer and Brain Neoplasm, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Recruiting at 1 site in United States. Open to participants aged 8 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Observational
Background:
Some people with brain tumors have seizures related to the tumor. This is called tumor-related epilepsy. Usually brain tumors are treated by removing as much of the brain tumor as possible without causing problems. Researchers think this may improve the outcome for people with brain tumors. It may completely relieve or greatly reduce the number of seizures they have.
Objectives:
To evaluate people with brain tumors that are associated with seizures and to offer surgical treatment. Also, to study how surgery affects seizures.
Eligibility:
People age 8 and older who have a brain tumor with associated seizures. They must be willing to have brain surgery to treat their epilepsy.
Design:
Participants will be screened with a review of their medical records.
Participants will have a medical history and physical exam.
Participants will be admitted to the hospital at NIH. They will have
Medical history
Physical exam
Neurological exam
Tests of memory, attention, and thinking
Questions about their symptoms and quality of life
Blood drawn
They may also have:
MRI or CT scan. They will lie on a table that slides in and out of a machine that takes pictures. For part of the MRI, they will get a dye through an intravenous (IV) catheter.
Video electroencephalography monitoring. Electrodes will be placed on the scalp. The participant s brain waves will be recorded while doing normal activities. Participants will be videotaped.
Participants will keep a seizure diary before and after surgery.
Participants will have surgery to remove their brain tumor and the brain area where their seizures start.
They will stay in the hospital up to a week after surgery.
Participants have for follow-up visits at NIH.
Objective
This protocol is being performed to 1) study the natural history and disease pathogenesis in patients with tumor related epilepsy, 2) collect prospective data on seizure outcomes following standard surgical treatment of brain tumors with associated seizures2, 3) follow the clinical course of patients after surgical resection of brain tumors with associated seizures, such as outcomes in seizure activity as they relate to type of tumor and extent of resection, 4) investigate neuropsychological and cognitive outcomes as they relate to surgical and seizure outcomes, 5) evaluate patient reported outcomes such as symptom burden changes as a result of surgical resection in patients with tumor-related epilepsy, 6) examine changes in structural and, when available, functional imaging in the context of tumor related epilepsy before and after surgical resection, 8) investigate molecular markers of tumor-related seizures in tumor and peritumoral specimens and, when available, to compare them to electrophysiological markers of tumor-related seizure activity.
Study Population
Patients 8 years and older with brain tumors and associated seizures may participate in this study.
Study Design
Patients will be screened by study neurosurgeon or neuro-oncologists to verify their confirmed or likely diagnosis of brain tumor and associated seizures. Patients confirmed to have a brain tumor with associated seizures will be offered standard diagnostic and surgical procedures. Non-invasive diagnostic procedures include structural MRI and neuropsychological, cognitive, and outcome assessments which may be performed under other NIH protocols. Some patients may receive functional MRI when clinically indicated, which will be performed under separate NIH protocols. Prior to tumor resection, diagnostic invasive monitoring with intracranial electrodes for further localization of seizure focus and identification of eloquent cortex may be clinically required. In these cases, invasive monitoring will be performed under a separate protocol, 11-N-0051 Epilepsy Surgery. Patients will be followed for three-six months after the surgical procedure to collect prospective data on seizure outcomes following standard surgical treatment of brain
tumors with associated seizures. Patients may also be seen at one year following surgery if medically stable and healthy. Participants in this protocol will not forego other standard treatments for their brain tumor, including chemotherapy and radiation treatment. Participation in this protocol will not preclude eligibility or participation in other NIH clinical trials.
Outcome Measures
The primary outcome measure is the change in seizure frequency, as measured by the Engel scale before and 3-6 months after treatment. Secondary outcome measures include 1) mean Engel Class and absolute and relative change in seizure frequency three-six months after surgery stratified by the type of brain tumor and location and Engel scale, seizure frequency, and mean Engel Class and absolute and relative change in seizure frequency one year after surgery stratified by the type of brain tumor and location; 2) extent of tumor and peri-tumoral resection as seen on MRI imaging and correlation with seizure outcome; 3) changes in neuropsychological and cognitive assessment following surgical resection stratified by location and type of tumor and extent of resection; 4) longitudinal changes in symptom burden and interference scores using established instruments in brain tumor patients; 5) changes in structural imaging following surgical resection; 6) change in the use of anti-epileptic medication; and 7) percentage of patients with permanent neurological side-effects from surgical treatment.
One hundred patients, male and female, age 8 or older, with tumor related epilepsy will be enrolled. Patients who withdraw from the protocol will be replaced. The target number of patients completing this study is 100.
To be eligible for entry into the study, a candidate must meet all the following criteria:
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.
Patients who have solitary primary or recurrent brain tumor with associated seizures.
change in seizure frequency, as measured by the Engel scale
The primary outcome measure is the Engel scale of patients 3-6 months after treatment. Engel s classification: Class I: patients who were completely seizure free, had auras only, or had convulsions with drug withdrawal only; Class II: rare disabling seizures or nocturnal seizures only; Class III: worthwhile improvement (frequent seizures but fewer than previously); Class IV: no improvement (frequent seizures with unchanged frequency compared to before surgery). Seizure frequency before and after surgical resection will be documented to determine Engel classification.
Time frame: 3-6 months after surgery
Mean Engel Class stratified by the type of brain tumor and location
Mean Engel Class three to six months after surgery stratified by the type of brain tumor and location and Engel scale, seizure frequency, and mean Engel Class one year after surgery stratified by the type of brain tumor and location
Time frame: 3-6 months after surgery
Extent of tumor and peri-tumoral resection as seen on MRI imaging and correlation with seizure outcome
Extent of tumor resection as seen on MRI imaging and correlation with seizure outcome
Time frame: 3-6 months after surgery
Changes in neuropsychological and cognitive assessment following surgical resection stratified by location and type of tumor and extent of resection
Changes in neuropsychological and cognitive assessment following surgical resection stratified by location and type of tumor and extent of resection
Time frame: 3-6 months after surgery
Longitudinal changes in symptom burden and interference scores using established instruments in brain tumor patients
Changes in symptom burden and interference with daily activities and quality of life
Time frame: 3-6 months after surgery
Changes in structural imaging following surgical resection
Changes in structural imaging following surgical resection
Time frame: 3-6 months after surgery
Change in the use of anti-epileptic medication
Percentage of patients who are able to be completely withdrawn from anti-epileptic medication
Time frame: 3-6 months after surgery
Percentage of patients with permanent neurological side-effects from surgical treatment
Percentage of patients with permanent neurological side-effects from surgical treatment.
Time frame: 3-6 months after surgery
Plan to share: Undecided — We do plan to share IPD. We will share all IPD that results in a publication on a public repository, as required by most journals. The data will be de-identified and anonymized.
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National Institute of Neurological Disorders and Stroke (NINDS)