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

NCT02151175 | Enrolling By Invitation

• 1 other identifier: BX001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy, Temporal Lobe

Outcome Measures

Primary Outcomes (1)

• Absence of histological changes

  7 days

Secondary Outcomes (5)

• Brief Symptom Inventory changes

  1 day

• Beck Depression Inventory changes

  1 day

• Neuropsychiatric changes

  1 day

• Neurological changes

  1 day

• Seizure frequency changes

  6 days

Other Outcomes (3)

• Change in BOLD signal

  Same day

• Change in epileptiform discharges

  Same day

• Change in epileptiform discharge %

  Same day

Study Arms (1)

LIFUP

EXPERIMENTAL

Device: LIFUP

Interventions

LIFUP DEVICE

LIFUP

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BrainSonix Inc.: lead
• Gerald J. & Dorothy R. Friedman Center for Lymphedema Research & Treatment: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Related 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 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.

  PMID: 34198105 RESULT

MeSH Terms

Conditions

Epilepsy, Temporal Lobe

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: May 30, 2014
• Study Start: May 1, 2014
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

US (1)