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|NCT02639325 : Tumor Related Epilepsy|
|Ages||Min: 8 Years Max: N/A|
- 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
- Agree to undergo brain surgery.
- Willing and able to appoint a durable power of attorney.
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.
|Links||Permanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02639325
| Link to official Clinicaltrials.gov listing
Facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
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