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New treatment option for Drug Resistant Epilepsy
Official title Low Intensity Focused Ultrasound Epilepsy: A Pilot Trial
ClinicalTrials.gov ID: NCT03868293
What this study is testing
- What it's testing
- 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.
- Time commitment: about 3 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people at least eighteen (18) years of age
- people with drug-resistant temporal lobe epilepsy whose seizures involve altered awareness (ie failed at least two trials of antiepileptic drugs for...
- people 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...
- people who have the cognitive ability to read and understand the consent form, describe any potential symptoms experienced during or after treatments.
You likely can't join if
- people with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with testing
- people with dementia or other progressive degenerative disease, delirium or active psychosis
- people with ferromagnetic materials in the head
- people with severe cardiac disease, increased intracranial pressure, or a Transcutaneous Electrical Nerve Stimulation (TENS) unit
- people who have primary generalized epilepsy or non-epileptic seizures
- people who have experienced status epilepticus in the 3 months leading up to enrollment in the study
See the full eligibility criteria
- people at least eighteen (18) years of age
- people 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...
- people 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
- people who have the cognitive ability to read and understand the consent form, describe any potential symptoms experienced during or after treatments.
- people with a cognitive or psychiatric disorder that limits the ability to give informed consent or are unable to cooperate with testing
- people with dementia or other progressive degenerative disease, delirium or active psychosis
- people with ferromagnetic materials in the head
- people with severe cardiac disease, increased intracranial pressure, or a Transcutaneous Electrical Nerve Stimulation (TENS) unit
- people who have primary generalized epilepsy or non-epileptic seizures
- people who have experienced status epilepticus in the 3 months leading up to enrollment in the study
- people (females) who are pregnant, or are of childbearing potential and not willing to use reliable birth control during the treatment period.
- people who are unable to get a brain MRI for any reason (implanted metal in body, inability to lie still)
- people with current brain tumors or an intracranial vascular lesion
- people with severe, uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject...
- people with holes in the treatment area of the skull from trauma or prior surgery
- people with pacemakers, medication pumps, and other implanted electronic hardware. If a subject has a working Vagal Nerve Stimulator in place, the device will be turned off prior to each treatment session and then...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.