What this study is
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.
...
Study details
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Conditions
- Epilepsy · Cancer · Brain Neoplasm
- Enrolling
- 100 people
- Starts
- 2016-01-26
- Est. completion
- 2032-07-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 8 Years – 99 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openNational Institutes of Health Clinical Center
Bethesda, Maryland, United States
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contact800-411-1222 ext. TTY dial 711ccopr@nih.gov
Recruiting
Study team
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Study ID 160041
Principal investigator
Kareem A Zaghloul, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.