Enrolling by invitation NCT02151175
Low-intensity Focused Ultrasound Pulsation (LIFUP) for Treatment of Temporal Lobe Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LIFUP.
- Who it may be relevant to
- Registry conditions: Epilepsy, Temporal Lobe. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
LIFUP for Treatment of Temporal Lobe Epilepsy
Overview
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.
Interventions
- Device LIFUP
Primary outcome measures
- Absence of histological changes [Time frame: 7 days]
Secondary outcome measures (5)
- Brief Symptom Inventory changes [Time frame: 1 day]
- Beck Depression Inventory changes [Time frame: 1 day]
- Neuropsychiatric changes [Time frame: 1 day]
- Neurological changes [Time frame: 1 day]
- Seizure frequency changes [Time frame: 6 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- UCLA — Los Angeles
Publications
- 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. PMID 34198105
Identifiers
NCT: NCT02151175 · BX001