Clinical trial NCT02151175: Low-intensity Focused Ultrasound Pulsation (LIFUP) for Treatment of Temporal Lobe Epilepsy
Official title: LIFUP for Treatment of Temporal Lobe Epilepsy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Epilepsy, Temporal Lobe
Lead sponsor: BrainSonix Inc.
Sponsor class: INDUSTRY
Collaborators: name: Gerald J. & Dorothy R. Friedman Center for Lymphedema Research & Treatment
name: University of California, Los Angeles
First posted: 2014-05-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


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.

Primary outcomes:
measure: Absence of histological changes
timeFrame: 7 days
Secondary outcomes:
measure: Brief Symptom Inventory changes
timeFrame: 1 day
measure: Beck Depression Inventory changes
timeFrame: 1 day
measure: Neuropsychiatric changes
timeFrame: 1 day
measure: Neurological changes
timeFrame: 1 day
measure: Seizure frequency changes
timeFrame: 6 days
Other outcomes:
measure: Change in BOLD signal
timeFrame: Same day
measure: Change in epileptiform discharges
timeFrame: Same day
measure: Change in epileptiform discharge %
timeFrame: Same day
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
References:
citation: Stern JM, Spivak NM, Becerra SA, Kuhn TP, Korb AS, Kronemyer D, Khanlou N, Reyes SD, Monti MM, Schnakers C, Walshaw P, Keselman I, Cohen MS, Yong W, Fried I, Jordan SE, Schafer ME, Engel J Jr, Bystritsky A. Safety of focused ultrasound neuromodulation in humans with temporal lobe epilepsy. Brain Stimul. 2021 Jul-Aug;14(4):1022-1031. doi: 10.1016/j.brs.2021.06.003. Epub 2021 Jun 23.