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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Focused ultrasound

    Device

    Pulsed low intensity focused ultrasound

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Drug-Resistant Epilepsy (temporal lobe)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patient tolerability of moderate term, repeated exposure toPulsed Low-Intensity Focused Ultrasound (PLIFUS) (Adverse Events assessment)

The aim of the proposed pilot study is to investigate patient tolerability of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy. We hypothesize that the treatments will be well-tolerated, without adverse events.

Time frame
3 months
2

Efficacy of PLIFUS in reducing seizure frequency

The aim of the proposed pilot study is to investigate patient efficacy of moderate term, repeated exposure of Pulsed Low-Intensity Focused Ultrasound (PLIFUS) in patients with drug-resistant temporal lobe epilepsy .We hypothesize that PLIFUS stimulation will result in mechanical disruption of the target tissue (here, the epileptogenic focus), preserving the integrity of the tissue but rendering it unable (or less able) to mount seizure activity for a period of time. We, therefore, will assess improvement in subjects' seizure frequency by evaluating seizure frequency during and 30 days after the treatment period relative to a 30 day pre-treatment baseline period.

Time frame
3 months
3

Effect of PLIFUS on patient EEG (evaluate number of attenuated epileptiform discharges)

We hypothesize that subjects' EEGs will show improvement (fewer and/or attenuated epileptiform discharges). Study Epileptologists (either the PI or Co-I) will interpret EEG results during the first and last treatment session.

Time frame
3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Source ClinicalTrials.gov
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