Tumor Related Epilepsy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02639325|
Recruitment Status : Recruiting
First Posted : December 24, 2015
Last Update Posted : July 10, 2018
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|
This protocol is being performed to 1) study the natural history and disease pathogenesis in patients with tumor related epilepsy, 2) provide standard surgical treatment of brain tumors with associated seizures, 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 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.
Patients 8 years and older with brain tumors and associated seizures may participate in this study.
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 and outcome assessments. Some patients may receive functional MRI when clinically indicated, which will be performed under a separate protocol, 14-N-0061, Non-invasive pre-surgical evaluation of patients with focal epilepsy. Invasive procedures include surgical resection of the brain tumor and associated epileptogenic region. The ultimate goal of surgical resection is to safely remove tumor tissue and to remove or modify the associated epileptic focus. 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 separte protocol, 11-N-0051 Epilepsy Surgery. Patients will be followed for three months after the surgical procedure and will receive standard neurological examinations and MRI evaluation of the brain as dictated by their care indicated for the brain tumor. 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 NINDS or NCI clinical trials.
The primary outcome measure is the change in seizure frequency, as measured by the Engel scale before and 3 months after treatment. Secondary outcome measures include 1) mean Engel Class three 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; 2) extent of tumor and peri-tumoral resection as seen on MRI imaging and correlation with seizure outcome; 3) changes in neuropsychological 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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Tumor Related Epilepsy|
|Study Start Date :||December 23, 2015|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||September 1, 2020|
- Change in seizure frequency, as measured by the Engel scale [ Time Frame: 3 months ]
- Mean Engel Class stratified by the type of brain tumor and location [ Time Frame: 3 and 12 monhts ]
- Extent of tumor and peri-tumoral resection as seen on MRI imaging and correlation with seizure outcome [ Time Frame: 3 and 12 months ]
- Changes in neuropsychological assessment following surgical resection stratified by location and type of tumor and extent of resection [ Time Frame: 3 and 12 months ]
- Longitudinal changes in symptom burden and interference scores using established instruments in brain tumor patients [ Time Frame: 3 and 12 months ]
- Changes in structural imaging following surgical resection [ Time Frame: 3 and 12 months ]
- Change in the use of anti-epileptic medication [ Time Frame: 3 and 12 months ]
- Percentage of patients with permanent neurological side-effects from surgical treatment [ Time Frame: 3 and 12 months ]
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)|