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

April 12, 2023 updated by: BrainSonix Inc.

LIFUP for Treatment of Temporal Lobe Epilepsy

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LIFUP
Device: LIFUP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absence of histological changes
Time Frame: 7 days
7 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Change in BOLD signal
Time Frame: Same day
Same day
Change in epileptiform discharges
Time Frame: Same day
Same day
Change in epileptiform discharge %
Time Frame: Same day
Same day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BrainSonix Inc.

Collaborators

University of California, Los Angeles
Gerald J. & Dorothy R. Friedman Center for Lymphedema Research & Treatment

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimate)

May 30, 2014

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BX001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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