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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2027-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy, Temporal Lobe

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LIFUP

Group Type EXPERIMENTAL

LIFUP

Intervention Type DEVICE

Interventions

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LIFUP

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No