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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 : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

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.

...


Condition or disease
Epilepsy Cancer Brain Neoplasm

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Changes in structural imaging following surgical resection [ Time Frame: 3-6 months after surgery ]
    Changes in structural imaging following surgical resection

  6. 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

  7. 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.



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.


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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

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

Locations
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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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Kareem A Zaghloul, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
Additional Information:
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT02639325    
Other Study ID Numbers: 160041
16-N-0041
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 3, 2020
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:
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Brain Neoplasms
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms