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

LIFUP for Treatment of Temporal Lobe Epilepsy

Status

Enrolling by invitation

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02151175

Enrollment

Registered

2014-05-30

Start date

2014-05-31

Completion date

2027-05-31

Last updated

2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Temporal Lobe

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.

Interventions

DEVICELIFUP

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame
Absence of histological changes	7 days

Secondary

Measure	Time frame
Beck Depression Inventory changes	1 day
Neuropsychiatric changes	1 day
Neurological changes	1 day
Seizure frequency changes	6 days
Brief Symptom Inventory changes	1 day

Other

Measure	Time frame
Change in epileptiform discharge %	Same day
Change in epileptiform discharges	Same day
Change in BOLD signal	Same day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026