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

BrainSonix

Status

Invitation-only

Conditions

Epilepsy, Temporal Lobe

Treatments

Device: LIFUP

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02151175

BX001

Details and patient eligibility

About

We intend to use focused ultrasound to stimulate or suppress brain activity in patients with epilepsy. We hypothesize that focused ultrasound is capable of brain stimulation or suppression visible with functional MRI, and will not cause tissue damage.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.