CTRI/2011/07/001918
Completed
Phase 3
Radio surgery or Open surgery for Epilepsy (ROSE) Trial - ROSE
ational Institute of Health0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ational Institute of Health
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults (18 years and older) of either gender who would otherwise be eligible for temporal lobe resection will be offered enrollment for randomization to RS or ATL.
- •1\.Seizure type: Patients must have simple and/or complex partial seizures with or without secondary generalization.
- •2\.Seizure Frequency: 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).
- •3\.Patients with electrographic evidence of seizures arising from one temporal lobe, with radiographic evidence of mesial temporal sclerosis in the same temporal lobe will be included. Patients with normal MRIs, bilateral hippocampal damage, or cortical lesion will be excluded.
- •4\.Subjects should be on stable doses of antiepileptic medications for at least 3 months prior to treatment.
- •5\.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.
- •6\.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. For these reasons, only patients 18 years and older and with I.Q. greater than or equal to 70 will be included.
Exclusion Criteria
- •7\.Patients with any focal neurologic deficit that would make it difficult to detect a new radiation\-associated injury will be excluded. All patients will receive formal visual field testing (Humphrey) and patients with visual field deficits will be excluded.
- •8\.Patients with radiographic evidence of other pathologies such as vascular malformations or tumors will be excluded
- •9\.Patients with diabetes mellitus or hypertension will be excluded from this study because radiation injury to the brain is more common in these patients
- •10\.Subjects 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 medications.
- •11\.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 are excluded.
- •12\.Patients with any progressive neurological disorder (such as multiple sclerosis or systemic lupus erythematosis) are excluded.
- •13\.Patients with a history of poor compliance with past antiepileptic drug therapy as judged by the principal investigator are excluded.
- •14\.Patients with a recent history of abusing drugs or alcohol with significance as judged by the principal investigator are excluded.
- •15\.Patients who are receiving any investigational drugs at the time of enrollment are excluded.
- •16\.Patients with current use of vigabatrin are excluded. Past use does not exclude a patient pending a normal formal visual field test.
Outcomes
Primary Outcomes
Not specified
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