Tumor Related Epilepsy
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|ClinicalTrials.gov Identifier: NCT02639325|
Recruitment Status : Recruiting
First Posted : December 24, 2015
Last Update Posted : September 22, 2020
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.
To evaluate people with brain tumors that are associated with seizures and to offer surgical treatment. Also, to study how surgery affects seizures.
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.
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
Tests of memory, attention, and thinking
Questions about their symptoms and quality of life
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.
|Condition or disease|
|Epilepsy Cancer Brain Neoplasm|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Tumor Related Epilepsy|
|Actual Study Start Date :||January 26, 2016|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2025|
Patients who have solitary primary or recurrent brain tumor with associated seizures.
- Change in seizure frequency, as measured by the Engel scale [ Time Frame: 3-6 months after surgery ]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.
- Mean Engel Class stratified by the type of brain tumor and location [ Time Frame: 3-6 months after surgery ]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
- Extent of tumor and peri-tumoral resection as seen on MRI imaging and correlation with seizure outcome [ Time Frame: 3-6 months after surgery ]Extent of tumor resection as seen on MRI imaging and correlation with seizure outcome
- 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 ]Changes in neuropsychological and cognitive assessment following surgical resection stratified by location and type of tumor and extent of resection
- Longitudinal changes in symptom burden and interference scores using established instruments in brain tumor patients [ Time Frame: 3-6 months after surgery ]Changes in symptom burden and interference with daily activities and quality of life
- Changes in structural imaging following surgical resection [ Time Frame: 3-6 months after surgery ]Changes in structural imaging following surgical resection
- Change in the use of anti-epileptic medication [ Time Frame: 3-6 months after surgery ]Percentage of patients who are able to be completely withdrawn from anti-epileptic medication
- Percentage of patients with permanent neurological side-effects from surgical treatment [ Time Frame: 3-6 months after surgery ]Percentage of patients with permanent neurological side-effects from surgical treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639325
|Contact: Gretchen C Scott, R.N.||(301) 496-2921||SNBrecruiting@nih.gov|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Kareem A Zaghloul, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|