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OpenTrials
Enrolling by Invitation

NCT Number: NCT02151175

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

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.

Enrolling by Invitation

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LIFUP

Device

Primary outcomes

  1. Absence of histological changes

    Time frame: 7 days

Secondary outcomes

  1. Brief Symptom Inventory changes

    Time frame: 1 day

  2. Beck Depression Inventory changes

    Time frame: 1 day

  3. Neuropsychiatric changes

    Time frame: 1 day

  4. Neurological changes

    Time frame: 1 day

  5. Seizure frequency changes

    Time frame: 6 days

Other outcomes

  1. Change in BOLD signal

    Time frame: Same day

  2. Change in epileptiform discharges

    Time frame: Same day

  3. Change in epileptiform discharge %

    Time frame: Same day

Sponsors and collaborators

Lead sponsor

BrainSonix Inc.

Industry

Collaborators

  • Gerald J. & Dorothy R. Friedman Center for Lymphedema Research & Treatment
  • University of California, Los Angeles

Registry information

Official study title

LIFUP for Treatment of Temporal Lobe Epilepsy

Important dates

Study start
2014
Primary completion
2026
Study completion
2027
First posted
May 30, 2014
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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