Back to resultsLow-intensity Focused Ultrasound Pulsation (LIFUP) for Treatment of Temporal Lobe Epilepsy
Primary Purpose
Epilepsy, Temporal Lobe
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LIFUP
Sponsored by
About this trial
This is an interventional basic science trial for Epilepsy, Temporal Lobe
Eligibility 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.
Sites / Locations
- UCLA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LIFUP
Arm Description
Outcomes
Primary Outcome Measures
Absence of histological changes
Secondary Outcome Measures
Brief Symptom Inventory changes
Beck Depression Inventory changes
Neuropsychiatric changes
Neurological changes
Seizure frequency changes
Full Information
NCT ID
NCT02151175
First Posted
May 28, 2014
Last Updated
April 12, 2023
Sponsor
BrainSonix Inc.
Collaborators
Gerald J. & Dorothy R. Friedman Center for Lymphedema Research & Treatment, University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT02151175
Brief Title
Low-intensity Focused Ultrasound Pulsation (LIFUP) for Treatment of Temporal Lobe Epilepsy
Official Title
LIFUP for Treatment of Temporal Lobe Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 2014 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BrainSonix Inc.
Collaborators
Gerald J. & Dorothy R. Friedman Center for Lymphedema Research & Treatment, University of California, Los Angeles
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Temporal Lobe
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LIFUP
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
LIFUP
Primary Outcome Measure Information:
Title
Absence of histological changes
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Brief Symptom Inventory changes
Time Frame
1 day
Title
Beck Depression Inventory changes
Time Frame
1 day
Title
Neuropsychiatric changes
Time Frame
1 day
Title
Neurological changes
Time Frame
1 day
Title
Seizure frequency changes
Time Frame
6 days
Other Pre-specified Outcome Measures:
Title
Change in BOLD signal
Time Frame
Same day
Title
Change in epileptiform discharges
Time Frame
Same day
Title
Change in epileptiform discharge %
Time Frame
Same day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34198105
Citation
Stern JM, Spivak NM, Becerra SA, Kuhn TP, Korb AS, Kronemyer D, Khanlou N, Reyes SD, Monti MM, Schnakers C, Walshaw P, Keselman I, Cohen MS, Yong W, Fried I, Jordan SE, Schafer ME, Engel J Jr, Bystritsky A. Safety of focused ultrasound neuromodulation in humans with temporal lobe epilepsy. Brain Stimul. 2021 Jul-Aug;14(4):1022-1031. doi: 10.1016/j.brs.2021.06.003. Epub 2021 Jun 23.
Results Reference
result
Learn more about this trial
Low-intensity Focused Ultrasound Pulsation (LIFUP) for Treatment of Temporal Lobe Epilepsy
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