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Tumor Related Epilepsy

This study is currently recruiting participants.
Verified October 18, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02639325
First Posted: December 24, 2015
Last Update Posted: October 26, 2017
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.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
  Purpose

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.


Condition
Epilepsy Cancer Brain Neoplasm

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tumor Related Epilepsy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):

Primary Outcome Measures:
  • Change in seizure frequency, as measured by the Engel scale [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: December 23, 2015
Estimated Study Completion Date: September 1, 2020
Estimated Primary Completion Date: September 1, 2020 (Final data collection date for primary outcome measure)
Detailed Description:

Objective

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.

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 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.

Outcome Measures

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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.
  • Agree to undergo brain surgery.
  • Willing and able to appoint a durable power of attorney.

EXCLUSION CRITERIA:

Candidates will be excluded if they:

  • Have a bleeding disorder that cannot be corrected before invasive testing or surgery, or other medical conditions that would make surgery unsafe, such as lung or cardiac disease that would render them unable to tolerate the risk of general anesthesia, or severe immunodeficiency or systemic cancer not related to a brain lesion.
  • Cannot have an MRI scan.
  • Have multiple brain tumors, evidence of carcinomatous meningitis, gliomatosis cerebri, or primary CNS lymphoma. Patients with multiple metastatic lesions that for which surgery is not indicated will be exluded. Patients with peripheral neurological or systemic metabolic disorders that cause seizures will be excluded.
  • Have an underlying seizure disorder that is unrelated to the brain tumor, or underlying neurological disorder that is unrelated to the brain tumor and that may contribute to seizure activity.
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Gretchen C Scott, R.N. (301) 496-2921 gretchen.scott@nih.gov

Locations
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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Kareem A Zaghloul, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT02639325     History of Changes
Other Study ID Numbers: 160041
16-N-0041
First Submitted: December 23, 2015
First Posted: December 24, 2015
Last Update Posted: October 26, 2017
Last Verified: October 18, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Brain Tumor
Brain Cancer
Seizure Disorder
Seizures

Additional relevant MeSH terms:
Epilepsy
Brain Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms