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Observational Study of Tumor-Related Epilepsy

This study is for people aged 8 and older who have a brain tumor and seizures related to it (tumor-related epilepsy). Researchers want to understand more about this condition and how surgery to remove the brain tumor affects seizures. They will look at how often seizures happen after surgery, using a tool called the Engel scale, measured 3-6 months after the operation. The goal is to see if removing the tumor can reduce or stop seizures. This is an observational study, meaning researchers will follow participants and collect information without providing a specific experimental treatment.

Study design
This is an observational study with a planned enrollment of 100 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will have their medical records reviewed. They must be willing to have brain surgery to treat their epilepsy.
Compensation
Not stated in the trial record.
Follow-up
Seizure frequency will be measured at 3-6 months after surgery.

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NCT02639325

Tumor Related Epilepsy

Recruiting
Not specifiedAges 8–99Observational
National Institute of Neurological Disorders and Stroke (NINDS)
~100 participants
Updated 2026-08-28 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
change in seizure frequency, as measured by the Engel scale
Measured over 3-6 months after surgery

Conditions

Epilepsy
Cancer
Brain Neoplasm

Explore related trials

Brain NeoplasmSeizure Disorder

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Kareem A Zaghloul, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Neurological Disorders and Stroke (NINDS)

Who to contact

Gretchen C Scott, R.N.
[email protected]
(301) 496-2921
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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • change in seizure frequency, as measured by the Engel scale3-6 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.