EpilepsyNCT02639325
Tumor Related Epilepsy
An observational study of Epilepsy and Cancer, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 99 years
- Conditions the study is for
- Epilepsy, Cancer, Brain Neoplasm
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2016to 1 Jul 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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.
Read more
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.
Read the detailed description
Objective
This protocol is being performed to 1) study the natural history and disease pathogenesis in patients with tumor related epilepsy, 2) collect prospective data on seizure outcomes following standard surgical treatment of brain tumors with associated seizures2, 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 and cognitive 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, cognitive, and outcome assessments which may be performed under other NIH protocols. Some patients may receive functional MRI when clinically indicated, which will be performed under separate NIH protocols. 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 separate protocol, 11-N-0051 Epilepsy Surgery. Patients will be followed for three-six months after the surgical procedure to collect prospective data on seizure outcomes following standard surgical treatment of brain
tumors with associated seizures. 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 NIH clinical trials.
Outcome Measures
The primary outcome measure is the change in seizure frequency, as measured by the Engel scale before and 3-6 months after treatment. Secondary outcome measures include 1) mean Engel Class and absolute and relative change in seizure frequency three-six months after surgery stratified by the type of brain tumor and location and Engel scale, seizure frequency, and mean Engel Class and absolute and relative change in seizure frequency 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 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; 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.
- Conditions
- Epilepsy, Cancer, Brain Neoplasm
- Keywords
- Brain Tumor, Brain Cancer, Seizure Disorder, Seizures, Natural History
- Medical subject headings
- Epilepsy, Neoplasms, Brain Neoplasms, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients who have solitary primary or recurrent brain tumor with associated seizures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-6 months after surgery
Secondary outcomes (7)
Mean Engel Class stratified by the type of brain tumor and location
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
Measured: 3-6 months after surgery
Extent of tumor and peri-tumoral resection as seen on MRI imaging and correlation with seizure outcome
Extent of tumor resection as seen on MRI imaging and correlation with seizure outcome
Measured: 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
Changes in neuropsychological and cognitive assessment following surgical resection stratified by location and type of tumor and extent of resection
Measured: 3-6 months after surgery
Longitudinal changes in symptom burden and interference scores using established instruments in brain tumor patients
Changes in symptom burden and interference with daily activities and quality of life
Measured: 3-6 months after surgery
Changes in structural imaging following surgical resection
Changes in structural imaging following surgical resection
Measured: 3-6 months after surgery
Change in the use of anti-epileptic medication
Percentage of patients who are able to be completely withdrawn from anti-epileptic medication
Measured: 3-6 months after surgery
Percentage of patients with permanent neurological side-effects from surgical treatment
Percentage of patients with permanent neurological side-effects from surgical treatment.
Measured: 3-6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study start26 Jan 2016
- Primary completion1 Jul 2032 (estimated)
- Study completion1 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kareem A Zaghloul, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639325
- Sponsor's protocol ID
- 160041
- Other IDs
- 16-N-0041
- Status last verified
- 6 Jan 2026
- First submitted
- 23 Dec 2015
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We do plan to share IPD. We will share all IPD that results in a publication on a public repository, as required by most journals. The data will be de-identified and anonymized.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Related Epilepsy
- ClinicalTrials.gov ID
- NCT02639325
- Acronym / sponsor ID
- 160041
- Conditions
- Epilepsy, Cancer, Brain Neoplasm
- Keywords
- Brain Tumor, Brain Cancer, Seizure Disorder, Seizures, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 26 Jan 2016 (actual)
- Primary completion
- 1 Jul 2032 (estimated)
- Study completion
- 1 Jul 2032 (estimated)
- First posted
- 24 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective
This protocol is being performed to 1) study the natural history and disease pathogenesis in patients with tumor related epilepsy, 2) collect prospective data on seizure outcomes following standard surgical treatment of brain tumors with associated seizures2, 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 and cognitive 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, cognitive, and outcome assessments which may be performed under other NIH protocols. Some patients may receive functional MRI when clinically indicated, which will be performed under separate NIH protocols. 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 separate protocol, 11-N-0051 Epilepsy Surgery. Patients will be followed for three-six months after the surgical procedure to collect prospective data on seizure outcomes following standard surgical treatment of brain
tumors with associated seizures. 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 NIH clinical trials.
Outcome Measures
The primary outcome measure is the change in seizure frequency, as measured by the Engel scale before and 3-6 months after treatment. Secondary outcome measures include 1) mean Engel Class and absolute and relative change in seizure frequency three-six months after surgery stratified by the type of brain tumor and location and Engel scale, seizure frequency, and mean Engel Class and absolute and relative change in seizure frequency 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 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; 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients who have solitary primary or recurrent brain tumor with associated seizures. |
Who may qualify
- Ages
- 8 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Mean Engel Class stratified by the type of brain tumor and location
Time frame: 3-6 months after surgery
Extent of tumor and peri-tumoral resection as seen on MRI imaging and correlation with seizure outcome
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
Time frame: 3-6 months after surgery
Longitudinal changes in symptom burden and interference scores using established instruments in brain tumor patients
Time frame: 3-6 months after surgery
Changes in structural imaging following surgical resection
Time frame: 3-6 months after surgery
Change in the use of anti-epileptic medication
Time frame: 3-6 months after surgery
Percentage of patients with permanent neurological side-effects from surgical treatment
Time frame: 3-6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We do plan to share IPD. We will share all IPD that results in a publication on a public repository, as required by most journals. The data will be de-identified and anonymized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kareem A Zaghloul, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Cancer, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gretchen C Scott, R.N. ((301) 496-2921, SNBrecruiting@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in seizure frequency, as measured by the Engel scale (time frame: 3-6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.