Low Intensity Focused Ultrasound Epilepsy: A Pilot Trial
ConditionDrug Resistant Epilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About this trial
The aim of the proposed pilot study is to investigate patient tolerability and efficacy of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy.
Eligibility criteria
Qualifiers
Subjects at least eighteen (18) years of age
Subjects with drug-resistant temporal lobe epilepsy whose seizures involve altered awareness (ie failed at least two trials of antiepileptic drugs for seizures), as determined by one of the BWH epilepsy neurologists based on clinical seizure semiology and/or EEG findings.
Subjects who experience at least 1-2 seizures per month on average, are aware of or have reliable caregivers who are aware of when seizures occur and can reliably log seizure frequency
Subjects who have the cognitive ability to read and understand the consent form, describe any potential symptoms experienced during or after treatments.
Disqualifiers
Subjects with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with testing
Subjects with dementia or other progressive degenerative disease, delirium or active psychosis
Subjects with ferromagnetic materials in the head
Subjects with severe cardiac disease, increased intracranial pressure, or a Transcutaneous Electrical Nerve Stimulation (TENS) unit
Trial design
Treatments tested in this trial
- Focused ultrasound
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov