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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 : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Ellen J Bubrick, Brigham and Women's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Drug Resistant Epilepsy Device: Focused ultrasound Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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, 2020
Estimated Study Completion Date : February 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Ultrasound

Arm Intervention/treatment
Experimental: Drug-Resistant Epilepsy (temporal lobe)
Pulsed low intensity focused ultrasound
Device: Focused ultrasound
Pulsed low intensity focused ultrasound




Primary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects at least eighteen (18) years of age
  • 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
  • Subjects who have the cognitive ability to read and understand the consent form, describe any potential symptoms experienced during or after treatments.

Exclusion Criteria:

  • Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with testing
  • Subjects with dementia or other progressive degenerative disease, delirium or active psychosis
  • Subjects with ferromagnetic materials in the head
  • Subjects with severe cardiac disease, increased intracranial pressure, or a Transcutaneous Electrical Nerve Stimulation (TENS) unit
  • Subjects who have primary generalized epilepsy or non-epileptic seizures
  • Subjects who have experienced status epilepticus in the 3 months leading up to enrollment in the study
  • Subjects (females) who are pregnant, or are of childbearing potential and not willing to use reliable birth control during the treatment period.
  • Subjects who are unable to get a brain MRI for any reason (implanted metal in body, inability to lie still)
  • Subjects with current brain tumors or an intracranial vascular lesion
  • Subjects with severe, uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation.
  • Subjects with holes in the treatment area of the skull from trauma or prior surgery
  • Subjects with pacemakers, medication pumps, and other implanted electronic hardware. If a subject has a working Vagal Nerve Stimulator in place, the device will be turned off prior to each treatment session and then turned back on after each session.

Information from the National Library of Medicine

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


Contacts
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Contact: Ellen J Bubrick, MD 617-732-7432 ebubrick@bwh.harvard.edu
Contact: Patrick S Trouten, BA 857-307-2383 ptrouten@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Ellen J Bubrick, MD    617-732-7432    ebubrick@bwh.harvard.edu   
Contact: Patrick S Trouten, BA    857-307-2383    ptrouten@bwh.harvard.edu   
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Ellen J Bubrick, MD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Ellen J Bubrick, Brigham and Women's Hospital:

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Responsible Party: Ellen J Bubrick, Associate Professor of Neurology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03868293     History of Changes
Other Study ID Numbers: 2018P000125
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases