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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
Must not have
Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with the testing
Subjects (females) who are pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am able to understand and agree to the study's requirements.
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I am currently pregnant.
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I do not have severe heart issues, high brain pressure, or use a TENS unit.
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I experience widespread seizures or non-epileptic seizures.
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My seizures are caused by drugs, alcohol, a metabolic illness, or a progressive disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Gerald J. & Dorothy R. Friedman Center for Lymphedema Research & TreatmentOTHER
University of California, Los AngelesOTHER
1,567 Previous Clinical Trials
10,266,988 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
~2 spots leftby Nov 2026
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