Low-Intensity Focused Ultrasound Neuromodulation for Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low-intensity Focused Ultrasound, Sham.
- Who it may be relevant to
- Registry conditions: Epilepsy (Treatment Refractory), Epilepsy Comorbidities. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Neuromodulation Using Low-intensity Focused Ultrasound for Potential Treatment for Medically Refractory Temporal Lobe Epilepsy
Overview
This study is an invite only study looking at the effects of Low-Intensity Focused Ultrasound (LIFU) on epilepsy patients with implanted electrodes under the care of Dr. Shah.
Detailed description
This project will explore the use of Low-Intensity Focused Ultrasound (LIFU) as a non-invasive method to reduce seizures and potentially enhance cognitive functions in epilepsy patients. LIFU can target specific deep brain areas without surgery, offering an alternative to invasive procedures. The study focuses on patients who have an implanted Responsive Neurostimulation System (RNS). LIFU will be used to stimulate the entorhinal cortex, a brain region involved in both seizure activity and memory formation. Investigators are targeting the perforant pathway from EC to hippocampus, which primarily relies of layers II and III of EC. Therefore, this targeting will ensure that layers II and III of EC are within the beam profile of LIFU. During study visits, participant will receive non-invasive ultrasound stimulation in their brains. Investigators will measure seizure frequency and epileptic activity using the implanted RNS system to assess LIFU's effects for epilepsy. Neuropsychological and memory tests will be conducted before and after LIFU application to detect changes in cognitive functions. Investigators will compare results before and after stimulation to determine LIFU's effectiveness in reducing seizures and potentially improving memory or other cognitive functions.
Interventions
- Device Low-intensity Focused Ultrasound
focused ultrasound transducer. - Device Sham
Sham application of LIFU - energy blocked. Targeted to the same target as intervention.
Primary outcome measures
- Seizure Frequency [Time frame: 6 months past their final research study visit]
Secondary outcome measures (3)
- Report of Symptoms Questionnaires [Time frame: Within session, approximately over a 3 hour period.]
- Memory Encoding [Time frame: Within session, over approximately 3 hours.]
- Working Memory Task [Time frame: Within session, over approximately 3 hours.]
Eligibility criteria
Inclusion criteria
- Diagnosis of medically refractory focal epilepsy of mesial temporal onset
- RNS system implantation in the hippocampus
- Prior MRI and CT of the head
- Able to consent for themselves
- Internet access
Exclusion criteria
- TBI (ongoing, or in the prior 6 months)
- Currently pregnant or breastfeeding
- Progressive diseases - such as autoimmune epilepsies or diagnosis of a progressive neurological disorder
- Status epilepticus within one year of study start
- History of suicidal ideation or attempts in the last 6 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Fralin Biomedical Research Institute at VTC — Roanoke
Identifiers
NCT: NCT07353918 · IRB-24-2194