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

Last updated: August 5, 2024
Sponsor: BrainSonix Inc.
Overall Status: Active - Enrolling

Phase

N/A

Condition

Seizure Disorders

Epilepsy

Treatment

LIFUP

Clinical Study ID

NCT02151175
BX001
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects with clinical evidence from their diagnostic evaluations of unilateralhippocampal dysfunction and epileptogenicity.

  • Subjects with seizures that have been refractory to treatment with at least threecurrently marketed antiepileptic drugs.

  • Subjects with epilepsy who would clearly benefit from surgical intervention.

  • Subjects who have been offered a non-dominant anterior-mesial temporal loberesection as treatment for medication refractory epilepsy.

Exclusion

Exclusion Criteria:

  • Subjects with a cognitive or psychiatric disorder that limits the ability to giveinformed consent or are unable to cooperate with the testing.

  • Subjects with dementia, delirium and psychotic symptoms. - Subjects withferromagnetic materials in the head.

  • Subjects with severe cardiac disease, increased intracranial pressure, or a TENSunit.

  • Subjects who exhibit primary generalized seizures or pseudoseizures.

  • Subjects who have seizures secondary to drugs, alcohol, metabolic illness orprogressive degenerative disease.

  • Subjects who have experienced status epilepticus during the 3-week baseline periodprior to the operation.

  • Subjects (females) who are pregnant.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: LIFUP
Phase:
Study Start date:
May 01, 2014
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

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