Tumor Related Epilepsy

NCT02639325 | Recruiting

• 2 other identifiers: 16004116-N-0041
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Cancer; Brain Neoplasm; Epilepsy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3-6 months after surgery

Secondary Outcomes (7)

• Mean Engel Class stratified by the type of brain tumor and location

  3-6 months after surgery

• Extent of tumor and peri-tumoral resection as seen on MRI imaging and correlation with seizure outcome

  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

  3-6 months after surgery

• Longitudinal changes in symptom burden and interference scores using established instruments in brain tumor patients

  3-6 months after surgery

• Changes in structural imaging following surgical resection

  3-6 months after surgery

Study Arms (1)

Patients

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

Eligibility Criteria

• Age: 8 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Epilepsy; Neoplasms; Brain Neoplasms; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kareem A Zaghloul, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gretchen C Scott, R.N.

CONTACT

(301) 496-2921; SNBrecruiting@nih.gov

Kareem A Zaghloul, M.D.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: December 24, 2015
• Study Start: January 26, 2016
• Primary Completion (Estimated): July 1, 2032
• Study Completion (Estimated): July 1, 2032
• Last Updated: May 1, 2026

Record last verified: 2026-01-06

Locations

US (1)