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|NCT03417297 : A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy|
|Ages||Min: 18 Years Max: 65 Years|
- Disabling, medically refractory epilepsy (=2 anti-epileptic drug failures)
- Focal onset seizures with secondary generalization; with or without primary
- = 3 seizures/month on average within 3 months of enrollment.
- Stable medication dosage for 3 months before enrollment.
- Anterior Nucleus (AN) identifiable on MRI (structural T1 and T2 images).
- Willing to maintain seizure diary (3 months before & 3 months after).
- Involved care provider.
- Written informed consent to participate.
- 18-65 years of age, inclusive.
- Previous seizure work-up within 12 months of enrollment date to include:
- Home EEG or EMU video EEG or intracranial EEG.
- Baseline neuropsychological assessment, which includes the Wechsler Advanced
Clinical Solutions - Test of Premorbid Functioning (TOPF). Subjects obtaining an
IQ score of =70 on the TOPF will be included.
- High definition MRI imaging/PET imaging.
- Low seizure frequency (<3 seizures/month).
- Previous vagal nerve stimulator.
- Severe untreated neuropsychiatric disorders (untreated depression or behavioral
- Recent history of drugs or alcohol abuse.
- Generalized epilepsy (Lennox Gastaut, drop attacks).
- Post infectious epilepsy (post herpetic).
- Previous corpus callosotomy.
- Significant structural brain abnormalities.
- Unable or unwilling to maintain drug dosage for 3 months post treatment.
- Pregnant or not practicing birth control method acceptable to the principal
- History of claustrophobia.
- Known allergic reaction and/or hypersensitivity to IV dye and/or IV contrasting
- Skull Density Ratio (SDR) <0.4.
- IQ score of <70 on the Wechsler Advanced Clinical Solutions - Test of Premorbid
Functioning (TOPF), a measure conducted as part of baseline neuropsychological
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03417297
| Link to official Clinicaltrials.gov listing