Radiosurgery vs Lobectomy for Temporal Lobe Epilepsy (ROSE)
- Adults (18 years and older), male or female, who would otherwise be eligible for temporal lobe resection.
- Patients must have simple and/or complex partial seizures with or without secondary generalization.
- Patients must have at least 3 complex partial seizures during the 3 month (12 week) baseline seizure diary period with at
least 1 of 3 seizures occurring within the last 2 months (8 weeks).
- Patients with electrographic evidence of seizures arising from one temporal lobe, with radiographic evidence of mesial temporal
sclerosis in the same temporal lobe.
- Patients on stable doses of antiepileptic medications for at least 3 months prior to treatment.
- All female patients of childbearing age will have documented that they are using a safe and effective means of birth control
and will have a negative urine pregnancy test completed within 1 week prior to their treatment.
- Patients should be able to understand the potential benefits and risks of this therapy and be able to understand the protocol
and sign their own consent forms.
- Patients should not have significant psychiatric conditions that would make accurate assessment of seizure frequency difficult,
as judged by the principal investigator. Such conditions include a history of non-epileptic seizures, psychosis (other than
post-ictal psychosis) and severe mood disorders including suicide attempt within past 12 months or noncompliance with psychotropic
- Native English speakers from the U.S. or other English speaking countries or patients who learned English before age 5 and
were educated in English. Spanish speaking patients can be included as long as the study site can provide an officially translated
(IRB approved) consent form in Spanish. Non-Spanish speaking patients with English as a second language (ESL) and/or non-English
and non-Spanish speaking patients can be included only under the following conditions: 1) the study site must be able to have
the consent form translated into the patient's native language using an official translator, and 2) the study site's neuropsychologist
must be willing and able to assess the patient at baseline and post-treatment at 12, 24, and 36 months in that patient's native
language to ensure the patient's safety.
- Patients with normal MRIs, bilateral hippocampal damage, or cortical lesion.
- Patients with any focal neurologic deficit that would make it difficult to detect a new radiation-associated injury. All patients
will receive formal visual field testing (Humphrey) and patients with visual field deficits will be excluded.
- Patients with radiographic evidence of other pathologies such as vascular malformations or tumors.
- Patients with diabetes mellitus (because radiation injury to the brain is more common in patients with this condition).
- Patients with a history of significant past or present medical disorders determined severe enough to prevent participation
in a surgical trial by the principal investigator.
- Patients with any progressive neurological disorder (such as multiple sclerosis or systemic lupus erythematosis).
- Patients with a history of poor compliance with past antiepileptic drug therapy as judged by the principal investigator.
- Patients with a recent history of abusing drugs or alcohol with significance as judged by the principal investigator.
- Patients who are receiving any investigational drugs at the time of enrollment.
- Patients with current use of vigabatrin. Past use does not exclude a patient pending a normal formal visual field test.
- Patients who cannot be anticipated to participate for the full 36 months of the trial.
Last updated July 3, 2012