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

Epilepsy, Temporal Lobe Clinical Trial

Official title:

LIFUP for Treatment of Temporal Lobe Epilepsy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02151175
• Other study ID #: BX001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 2014
• Est. completion date: May 2025

Study information

• Verified date: April 2023
• Source: BrainSonix Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: May 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Temporal Lobe

Intervention

Device:
• LIFUP

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
BrainSonix Inc.	Gerald J. & Dorothy R. Friedman Center for Lymphedema Research & Treatment, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in BOLD signal		Same day
Other	Change in epileptiform discharges		Same day
Other	Change in epileptiform discharge %		Same day
Primary	Absence of histological changes		7 days
Secondary	Brief Symptom Inventory changes		1 day
Secondary	Beck Depression Inventory changes		1 day
Secondary	Neuropsychiatric changes		1 day
Secondary	Neurological changes		1 day
Secondary	Seizure frequency changes		6 days