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Low-intensity Focused Ultrasound Pulsation (LIFUP) for Treatment of Temporal Lobe Epilepsy

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ClinicalTrials.gov Identifier: NCT02151175
Recruitment Status : Recruiting
First Posted : May 30, 2014
Last Update Posted : February 18, 2019
Sponsor:
Collaborators:
Gerald J. & Dorothy R. Friedman Center for Lymphedema Research & Treatment
University of California, Los Angeles
Information provided by (Responsible Party):
BrainSonix Inc.

Study Description
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Brief Summary:
We intend to use focused ultrasound to stimulate or suppress brain activity in patients with epilepsy. We hypothesize that focused ultrasound is capable of brain stimulation or suppression visible with functional MRI, and will not cause tissue damage.

Condition or disease Intervention/treatment Phase
Epilepsy, Temporal Lobe Device: LIFUP Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: LIFUP for Treatment of Temporal Lobe Epilepsy
Actual Study Start Date : May 2014
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: LIFUP Device: LIFUP


Outcome Measures
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Primary Outcome Measures :
  1. Absence of histological changes [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Brief Symptom Inventory changes [ Time Frame: 1 day ]
  2. Beck Depression Inventory changes [ Time Frame: 1 day ]
  3. Neuropsychiatric changes [ Time Frame: 1 day ]
  4. Neurological changes [ Time Frame: 1 day ]
  5. Seizure frequency changes [ Time Frame: 6 days ]

Other Outcome Measures:
  1. Change in BOLD signal [ Time Frame: Same day ]
  2. Change in epileptiform discharges [ Time Frame: Same day ]
  3. Change in epileptiform discharge % [ Time Frame: Same day ]

Eligibility Criteria
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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:

  • Subjects with clinical evidence from their diagnostic evaluations of unilateral hippocampal dysfunction and epileptogenicity.
  • Subjects with seizures that have been refractory to treatment with at least three currently marketed antiepileptic drugs.
  • Subjects with epilepsy who would clearly benefit from surgical intervention.
  • Subjects who have been offered a non-dominant anterior-mesial temporal lobe resection as treatment for medication refractory 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 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 baseline period prior to the operation.
  • Subjects (females) who are pregnant.
Contacts and Locations
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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): NCT02151175


Locations
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United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Alex Korb, PhD    323-510-7532    alexkorb@ucla.edu   
Principal Investigator: John Stern, MD         
Sponsors and Collaborators
BrainSonix Inc.
Gerald J. & Dorothy R. Friedman Center for Lymphedema Research & Treatment
University of California, Los Angeles
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: BrainSonix Inc.
ClinicalTrials.gov Identifier: NCT02151175    
Other Study ID Numbers: BX001
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
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