Low Intensity Focused Ultrasound Treatment for Drug-Resistant Epilepsy: An Efficacy Trial (LIFUS)
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|ClinicalTrials.gov Identifier: NCT03868293|
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : January 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Drug Resistant Epilepsy||Device: Focused ultrasound||Not Applicable|
The aim of the proposed pilot study is to investigate patient tolerability and efficacy of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy. We hypothesize that the treatments will be well-tolerated, subjects' EEGs will show improvement (fewer epileptiform discharges), and that subjects will experience a reduction in seizure frequency as a result of the treatment without adverse events.
Due to the lack of options for patients with drug-resistant epilepsy, investigations into alternative noninvasive treatments are warranted. PLIFUS has been shown to safely modulate neuronal tissue, and is non-invasive and painless. Several human studies have shown that the use of PLIFUS can suppress somatosensory evoked potentials and induce functional magnetic resonance imaging (MRI) responses.
Once the subject is enrolled in the study, the subject will be scheduled for a standard brain MRI scan at BWH if they have not had one in the last 3 months. The subject will be asked to keep track of their seizure events in the Daily Seizure Log Diary from the screening visit until 2 months after the last treatment session.
The treatment period will include 8 treatment sessions total. These will occur 2 days per week for 4 weeks, each lasting approximately 1-2 hours, starting 1 month after seizure logging begins.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Low Intensity Focused Ultrasound Treatment for Drug-Resistant Epilepsy: An Efficacy Trial|
|Actual Study Start Date :||February 7, 2019|
|Estimated Primary Completion Date :||February 7, 2022|
|Estimated Study Completion Date :||February 7, 2022|
Experimental: Drug-Resistant Epilepsy (temporal lobe)
Pulsed low intensity focused ultrasound
Device: Focused ultrasound
Pulsed low intensity focused ultrasound
- Patient tolerability of moderate term, repeated exposure toPulsed Low-Intensity Focused Ultrasound (PLIFUS) (Adverse Events assessment) [ Time Frame: 3 months ]The aim of the proposed pilot study is to investigate patient tolerability of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy. We hypothesize that the treatments will be well-tolerated, without adverse events.
- Efficacy of PLIFUS in reducing seizure frequency [ Time Frame: 3 months ]
The aim of the proposed pilot study is to investigate patient efficacy of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy .We hypothesize that PLIFUS stimulation will result in mechanical disruption of the target tissue (here, the epileptogenic focus), preserving the integrity of the tissue but rendering it unable (or less able) to mount seizure activity for a period of time.
We, therefore, will assess improvement in subjects' seizure frequency by evaluating seizure frequency during and 30 days after the treatment period relative to a 30 day pre-treatment baseline period.
- Effect of PLIFUS on patient EEG (evaluate number of attenuated epileptiform discharges) [ Time Frame: 3 months ]We hypothesize that subjects' EEGs will show improvement (fewer and/or attenuated epileptiform discharges). Study Epileptologists (either the PI or Co-I) will interpret EEG results during the first and last treatment session.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868293
|Contact: Ellen J Bubrick, MDemail@example.com|
|Contact: Patrick S Trouten, BAfirstname.lastname@example.org|
|Principal Investigator:||Ellen J Bubrick, MD||Brigham and Women's Hospital|