Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03417297 : A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
PhaseN/A
AgesMin: 18 Years Max: 65 Years
Eligibility
Inclusion Criteria:

- Disabling, medically refractory epilepsy (=2 anti-epileptic drug failures)

- Focal onset seizures with secondary generalization; with or without primary
generalized seizures.

- = 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.

Exclusion Criteria:

- Low seizure frequency (<3 seizures/month).

- Previous vagal nerve stimulator.

- Severe untreated neuropsychiatric disorders (untreated depression or behavioral
problems).

- 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
investigator.

- History of claustrophobia.

- Known allergic reaction and/or hypersensitivity to IV dye and/or IV contrasting
agent(s).

- 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
assessment.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03417297      |      Link to official Clinicaltrials.gov listing
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