Low-intensity Focused Ultrasound Pulsation (LIFUP) for Treatment of Temporal Lobe Epilepsy

Launched by BRAINSONIX INC. · May 28, 2014

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects with clinical evidence from their diagnostic evaluations of unilateral hippocampal dysfunction and epileptogenicity.
• • Subjects with seizures that have been refractory to treatment with at least three currently marketed antiepileptic drugs.
• • Subjects with epilepsy who would clearly benefit from surgical intervention.
• • Subjects who have been offered a non-dominant anterior-mesial temporal lobe resection as treatment for medication refractory epilepsy.
• Exclusion Criteria:
• • Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with the testing.
• • Subjects with dementia, delirium and psychotic symptoms. - Subjects with ferromagnetic materials in the head.
• • Subjects with severe cardiac disease, increased intracranial pressure, or a TENS unit.
• • Subjects who exhibit primary generalized seizures or pseudoseizures.
• • Subjects who have seizures secondary to drugs, alcohol, metabolic illness or progressive degenerative disease.
• • Subjects who have experienced status epilepticus during the 3-week baseline period prior to the operation.
• • Subjects (females) who are pregnant.