Clinical Trial Finder

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  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.

EXCLUSION CRITERIA:

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.

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.

Arms

: Patients

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

Interventions