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Focused Ultrasound

Focused Ultrasound for Epilepsy (LIFUS Trial)

N/A

Recruiting

Led By Ellen J Bubrick, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

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

Must have

Subjects with drug-resistant temporal lobe epilepsy whose seizures involve altered awareness (ie failed at least two trials of antiepileptic drugs for seizures), as determined by one of the BWH epilepsy neurologists based on clinical seizure semiology and/or EEG findings.

Subjects who experience at least 1-2 seizures per month on average, are aware of or have reliable caregivers who are aware of when seizures occur and can reliably log seizure frequency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a new ultrasound treatment can help epilepsy patients who haven't been helped by drugs.

Who is the study for?

This trial is for adults with drug-resistant temporal lobe epilepsy, experiencing 1-2 seizures monthly. Participants must be able to log seizure frequency and understand the consent form. They should have failed at least two antiepileptic drug trials.

What is being tested?

The study tests the tolerability and effectiveness of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) on patients with drug-resistant temporal lobe epilepsy through moderate term, repeated exposure.

What are the potential side effects?

Potential side effects are not explicitly listed in the provided information but may include discomfort or other symptoms related to ultrasound exposure which participants will report during or after treatments.

Eligibility Criteria

Inclusion Criteria

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

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I have temporal lobe epilepsy that hasn't improved with at least two different seizure medications.

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I have 1-2 seizures monthly and can track them myself or with help.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effect of PLIFUS on patient EEG (evaluate number of attenuated epileptiform discharges)

Efficacy of PLIFUS in reducing seizure frequency

Patient tolerability of moderate term, repeated exposure toPulsed Low-Intensity Focused Ultrasound (PLIFUS) (Adverse Events assessment)

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: Drug-Resistant Epilepsy (temporal lobe)Experimental Treatment1 Intervention

Pulsed low intensity focused ultrasound

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,666 Previous Clinical Trials

11,841,614 Total Patients Enrolled

11 Trials studying Epilepsy

54,303 Patients Enrolled for Epilepsy

Ellen J Bubrick, MD3.76 ReviewsPrincipal Investigator - Brigham and Women's Hospital

Brigham and Women's Hospital

1Patient Review

Dr. Bubrick put me in danger by threatening to have me hospitalized on Friday, August 30th, 2014, after my operation. This caused me to have a seizure on my 90 year old neighbor's floor. She said, "Shelley, you are alright, you do not need to be here in the emergency room, or readmitted to the hospital! I have two choices for you, and I hope you choose the right one! The first choice is to go home, and I hope that you do, because the next choice is a psychiatric hospitalization"!!!!! Dr. Bubrick never attended the meeting with my former PC