Low-intensity Focused Ultrasound Pulsation (LIFUP) for Treatment of Temporal Lobe Epilepsy
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epilepsy, Temporal Lobe | Device: LIFUP | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: LIFUP |
Device: LIFUP |
- Absence of histological changes [ Time Frame: 7 days ]
- 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 ]
- Change in BOLD signal [ Time Frame: Same day ]
- Change in epileptiform discharges [ Time Frame: Same day ]
- Change in epileptiform discharge % [ Time Frame: Same day ]

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

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
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 |
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 |
Epilepsy Epilepsy, Temporal Lobe Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Epilepsies, Partial Epileptic Syndromes |