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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE May 28, 2014
First Posted Date  ICMJE May 30, 2014
Last Update Posted Date February 18, 2019
Actual Study Start Date  ICMJE May 2014
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
Absence of histological changes [ Time Frame: 7 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02151175 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
  • Brief Symptom Inventory changes [ Time Frame: 1 day ]
  • Beck Depression Inventory changes [ Time Frame: 1 day ]
  • Neuropsychiatric changes [ Time Frame: 1 day ]
  • Neurological changes [ Time Frame: 1 day ]
  • Seizure frequency changes [ Time Frame: 6 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 28, 2014)
  • Change in BOLD signal [ Time Frame: Same day ]
  • Change in epileptiform discharges [ Time Frame: Same day ]
  • Change in epileptiform discharge % [ Time Frame: Same day ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Low-intensity Focused Ultrasound Pulsation (LIFUP) for Treatment of Temporal Lobe Epilepsy
Official Title  ICMJE LIFUP for Treatment of Temporal Lobe Epilepsy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Epilepsy, Temporal Lobe
Intervention  ICMJE Device: LIFUP
Study Arms  ICMJE Experimental: LIFUP
Intervention: Device: LIFUP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2014)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02151175
Other Study ID Numbers  ICMJE BX001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BrainSonix Inc.
Study Sponsor  ICMJE BrainSonix Inc.
Collaborators  ICMJE
  • Gerald J. & Dorothy R. Friedman Center for Lymphedema Research & Treatment
  • University of California, Los Angeles
Investigators  ICMJE Not Provided
PRS Account BrainSonix Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP