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Trial record 1 of 1 for:    18958151 [PUBMED-IDS]
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Focused Ultrasound Neuromodulation for Treatment of Temporal Lobe Epilepsy (LIFUP)

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ClinicalTrials.gov Identifier: NCT03657056
Recruitment Status : Not yet recruiting
First Posted : September 3, 2018
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Darin Dougherty, Massachusetts General Hospital

Brief Summary:
The aim of the proposed study is to assess the feasibility of using the BrainSonix BX Pulsar 1002 low-frequency and Low-Intensity Focused Ultrasound Pulsations (LIFUP) in human subjects suffering from intractable temporal lobe epilepsy. The patients selected will already be scheduled to undergo surgery for resection of the temporal lobe, and the investigational therapy will be applied to the temporal lobe at least one day prior to its scheduled removal. The study is intended to provide preliminary evidence of safety, and establish the feasibility of LIFUP treatment as evidenced by a modulation of the Blood-oxygenation level dependent (BOLD) signal in functional MRI (fMRI), and normal findings from histological examination of the resected brain tissue.

Condition or disease Intervention/treatment Phase
Low Intensity Ultrasound Pulsarions Device: BX Pulsar 1002 Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

Participants will be recruited from the normal population of patients being treated for temporal lobe epilepsy Massachusetts General Hospital.

Patients identified as candidates for temporal lobe surgery by the clinical team will be notified via a letter that has been signed by a physician representative of the practice of their eligibility for the study. An administrator will follow-up on the letter with a phone call. The physician of potential participants will be notified of their eligibility for the study, and be provided with a copy of the consent form. A total of 3 participants will be enrolled in the project.

Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Focused Ultrasound Neuromodulation for Treatment of Temporal Lobe Epilepsy
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Ultrasound

Arm Intervention/treatment
Experimental: BX Pulsar 1002
Low-Intensity Focused Ultrasound Pulsation (LIFUP) sonications will be conducted using the LIFUP experimental device BX Pulsar 1002 produced by the Brainsonix Corporation. For the purposes of safety LIFUP sonications will be initiated at the FDA limit for diagnostic ultrasound. However, the minimally effective dose in humans applications, according to (Lee et al., 2015), when derated is approximately 1125mW/cm2.
Device: BX Pulsar 1002

LIFUP will be administered to the temporal region on the side to undergo surgery, within the focus producing seizures. The ultrasound will be focused on the highest activity area within the temporal lobe. Functional MRI of the brain will be obtained throughout the LIFUP session.

After the participant is fitted with the transducer they will be placed in the MRI machine and undergo a series of scans. After placing the transducer over the anterior tip of the temporal lobe the participant will undergo fMRI BOLD scans with LIFUP excitation (from (Lee et al., 2015): Tone Burst Duration = 2ms and Pulse Repetition Frequency = 250Hz) at four levels of intensity (720mW/cm2, 1440mW/cm2, 2880mW/cm2 and 5760mW/cm2). Before increasing the intensity, the transducer will be moved approximately 5mm posterior. After the last excitation scan the LIFUP parameters will be changed to inhibitory parameters (from (Yoo et al., 2011): Tone Burst Duration = 0.5ms and Pulse Repetition Frequency = 100Hz).

Other Name: LIFUP




Primary Outcome Measures :
  1. FMRI - (Change in BOLD signal) [ Time Frame: 6 Months ]
    Change in BOLD signal during or after LIFUP sonication



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects, 18 to 60 years old.
  • Subjects with clinical evidence from their diagnostic evaluations of unilateral hippocampal - dysfunction and epileptogenicity, confirmed via intracarotid amobarbital procedure (IAP) and neuropsychological testing.
  • Subjects with seizures that have been refractory to treatment with at least three currently marketed antiepileptic drugs.
  • Subjects currently taking antiepileptic medications.
  • Subjects with at least 3 seizures/month based on seizure diary.
  • Subjects with epilepsy who would clearly benefit from surgical intervention.
  • Subjects who have been offered an anterior-mesial temporal lobe resection, performed en-bloc, as treatment for medication refractory epilepsy. This includes both dominant or non-dominant mesial temporal lobe focal epilepsy.

Exclusion Criteria:

  • Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with the testing.
  • Subjects with dementia, delirium and psychotic symptoms.
  • 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 exhibit primary generalized seizures or pseudoseizures.
  • Subjects who have seizures secondary to drugs, alcohol, metabolic illness or progressive degenerative disease.
  • Subjects who have experienced status epilepticus during the 3-week period prior to the LIFUP procedure.
  • Subjects (females) who are pregnant.
  • Patients who have had electrodes implanted in the brain that were not explanted at least 6 weeks prior to the LIFUP procedure.
  • Patients who have had electrodes implanted into the focal point of the temporal lobe that is proposed for the ultrasonic stimulation using LIFUP.

Publications:

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Responsible Party: Darin Dougherty, Director, Division of Neurotherapeutics, Department of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03657056     History of Changes
Other Study ID Numbers: 2018P001352
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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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
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Darin Dougherty, Massachusetts General Hospital:
Epilepsy
Ultrasound
Additional relevant MeSH terms:
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Epilepsy
Epilepsy, Temporal Lobe
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial
Epileptic Syndromes