Epilepsy (Treatment Refractory)NCT07353918
Low-Intensity Focused Ultrasound Neuromodulation for Epilepsy
A study testing Low-intensity Focused Ultrasound in people with Epilepsy (Treatment Refractory) and Epilepsy Comorbidities, run by Carilion Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Epilepsy (Treatment Refractory), Epilepsy Comorbidities
- What is being tested?
- Low-intensity Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2025to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016
About this study
Official title: Neuromodulation Using Low-intensity Focused Ultrasound for Potential Treatment for Medically Refractory Temporal Lobe Epilepsy
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.
Read the 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.
- Being tested
- Low-intensity Focused Ultrasound, Sham
- Keywords
- LIFU, Neuromodulation, Seizure
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity Focused UltrasoundDevice
focused ultrasound transducer.
ShamDevice
Sham application of LIFU - energy blocked. Targeted to the same target as intervention.
| Study group | Role | What they receive |
|---|---|---|
| LIFU- real | Experimental | Low-intensity focused ultrasound will be applied to the entorhinal cortex in a pre/post design. Receives: Device: Low-intensity Focused Ultrasound |
| LIFU - Sham | Sham comparator | Sham Low-intensity focused ultrasound will be applied to the entorhinal cortex in a pre/post design. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure Frequency
Utilizing the implanted RNS system patient seizure frequency will be monitored over time following both real and sham intervention.
Measured: 6 months past their final research study visit
Secondary outcomes (3)
Report of Symptoms Questionnaires
To evaluate the safety profile and tolerability of LIFU delivery, measured by a series questionnaires pre and post LIFU application evaluating symptoms and side-effects. Participants are asked to report any existing (pre) \& new (post) symptoms
Measured: Within session, approximately over a 3 hour period.
Memory Encoding
To evaluate the cognitive effects of LIFU delivery on memory, participants will be assessed for correct vs incorrect encoding (face/name pair shown, \& then queried after a distractor task). % correct will be assessed.
Measured: Within session, over approximately 3 hours.
Working Memory Task
To evaluate the cognitive effects of LIFU delivery on working memory, participants will be assessed for correct vs incorrect encoding (given a list of objects, asked to recall in smallest to largest order). % correct will be assessed.
Measured: Within session, over approximately 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start13 Oct 2025
- Primary completionDec 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy (Treatment Refractory)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a within subject cross-over design with 1 visit with a real LIFU application, and 1 visit with a sham LIFU application. Order will be randomized.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aashit Shah, MD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353918
- Sponsor's protocol ID
- IRB-24-2194
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation Using Low-intensity Focused Ultrasound for Potential Treatment for Medically Refractory Temporal Lobe Epilepsy
- ClinicalTrials.gov ID
- NCT07353918
- Acronym / sponsor ID
- IRB-24-2194
- Keywords
- LIFU, Neuromodulation, Seizure
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a within subject cross-over design with 1 visit with a real LIFU application, and 1 visit with a sham LIFU application. Order will be randomized.
| Arm | Type | Receives |
|---|---|---|
| LIFU- real | Experimental | Device: Low-intensity Focused UltrasoundLow-intensity focused ultrasound will be applied to the entorhinal cortex in a pre/post design. |
| LIFU - Sham | Sham comparator | Device: ShamSham Low-intensity focused ultrasound will be applied to the entorhinal cortex in a pre/post design. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-intensity Focused Ultrasoundfocused ultrasound transducer. | Device | LIFU- real |
| ShamSham application of LIFU - energy blocked. Targeted to the same target as intervention. | Device | LIFU - Sham |
Primary outcome
Seizure Frequency
Time frame: 6 months past their final research study visit
Utilizing the implanted RNS system patient seizure frequency will be monitored over time following both real and sham intervention.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aashit Shah, MD principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity Focused Ultrasound in people with Epilepsy (Treatment Refractory) and Epilepsy Comorbidities, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure Frequency (time frame: 6 months past their final research study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.