Recruiting

Observational Study

Sponsor:

National Institute of Neurological Disorders and Stroke (NINDS)

Code:

NCT02639325

Conditions

Epilepsy

Cancer

Brain Neoplasm

Eligibility Criteria

Sex: All

Age: 8 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Epilepsy

Cancer

Brain Neoplasm

Study ID

NCT02639325

Start date

Jan 26, 2016

Status verified date

Jan 6, 2026

Completion date

Jul 1, 2032

Anticipated

Primary completion date

Jul 1, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients

Patients who have solitary primary or recurrent brain tumor with associated seizures.

Primary outcome measure

  • change in seizure frequency, as measured by the Engel scale [ Time Frame: 3-6 months after surgery ]

Central Contacts and Locations

Central contacts

Gretchen C Scott, R.N.

(301) 496-2921SNBrecruiting@nih.gov

Kareem A Zaghloul, M.D.

(301) 594-8114zaghloulka@mail.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Last update posted

Aug 28, 2026

Last verified

Jan 6, 2026

Keywords

  • Brain Tumor
  • Brain Cancer
  • Seizure Disorder
  • Seizures
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Neurological Disorders and Stroke (NINDS) on 2026-08-28.