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Ultrasound Therapy

Focused Ultrasound for Temporal Lobe Epilepsy

N/A

Waitlist Available

Research Sponsored by BrainSonix Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with seizures that have been refractory to treatment with at least three currently marketed antiepileptic drugs

Subjects who have been offered a non-dominant anterior-mesial temporal lobe resection as treatment for medication refractory epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

Study Summary

This trial will use focused ultrasound to stimulate or suppress brain activity in patients with epilepsy to see if it is effective and does not cause tissue damage.

Who is the study for?

This trial is for people with severe epilepsy that hasn't improved after trying at least three antiepileptic drugs. They should be candidates for a specific type of brain surgery and have evidence of dysfunction in one area of the hippocampus. People can't join if they can't consent, cooperate, or have metal in their head, serious heart issues, certain neurological conditions, or are pregnant.Check my eligibility

What is being tested?

The study tests Low-intensity Focused Ultrasound Pulsation (LIFUP) to see if it can stimulate or suppress brain activity without causing damage. This non-invasive technique's effects will be monitored using functional MRI in patients who could benefit from surgical intervention.See study design

What are the potential side effects?

While not explicitly stated, potential side effects may include discomfort at the site of ultrasound application, headache or mild irritation. Since LIFUP is non-invasive and doesn’t involve radiation or surgery directly, risks might be lower compared to other treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My seizures haven't improved despite trying three different epilepsy medications.

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I have epilepsy not controlled by medication and have been recommended a specific brain surgery.

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My tests show I have a problem with one side of my brain causing seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absence of histological changes

Secondary outcome measures

Beck Depression Inventory changes

Brief Symptom Inventory changes

Neurological changes

+2 more

Other outcome measures

Change in BOLD signal

Change in epileptiform discharge %

Change in epileptiform discharges

Trial Design

1Treatment groups

Experimental Treatment

Group I: LIFUPExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LIFUP

2019

N/A

~30

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gerald J. & Dorothy R. Friedman Center for Lymphedema Research & TreatmentOTHER

University of California, Los AngelesOTHER

1,529 Previous Clinical Trials

10,277,790 Total Patients Enrolled

BrainSonix Inc.Lead Sponsor

Media Library

Low-intensity Focused Ultrasound Pulsation (LIFUP) (Ultrasound Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02151175 — N/A

Temporal Lobe Epilepsy Research Study Groups: LIFUP

Temporal Lobe Epilepsy Clinical Trial 2023: Low-intensity Focused Ultrasound Pulsation (LIFUP) Highlights & Side Effects. Trial Name: NCT02151175 — N/A

Low-intensity Focused Ultrasound Pulsation (LIFUP) (Ultrasound Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02151175 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the criteria to take part in this medical experiment?

"The prerequisites for this experiment are that participants must have epilepsy, uncinate and fall between 18 to 60 years of age. The trial is seeking a contingent of 12 individuals."

Answered by AI

Are there still available slots for participants in this investigation?

"Clinicaltrials.gov indicates that this study, which was initially posted on May 1st 2014 and revised lastly on June 2nd 2021, is no longer enrolling patients. Notwithstanding, there are 240 other trials currently in search of volunteers."

Answered by AI