Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:36 AM
Study NCT ID:
NCT07353918
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-21
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-Intensity Focused Ultrasound Neuromodulation for Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will not know which visit is real and which is sham. Both appear identical to the participant. The sham is performed by blocking the energy applied to the skull during LIFU. Analysis will be done prior to unblinding researchers. Only researchers interacting with the participant will know visit order.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-16', 'studyFirstSubmitDate': '2025-12-22', 'studyFirstSubmitQcDate': '2026-01-16', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seizure Frequency', 'timeFrame': '6 months past their final research study visit', 'description': 'Utilizing the implanted RNS system patient seizure frequency will be monitored over time following both real and sham intervention.'}], 'secondaryOutcomes': [{'measure': 'Report of Symptoms Questionnaires', 'timeFrame': 'Within session, approximately over a 3 hour period.', 'description': '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'}, {'measure': 'Memory Encoding', 'timeFrame': 'Within session, over approximately 3 hours.', 'description': '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.'}, {'measure': 'Working Memory Task', 'timeFrame': 'Within session, over approximately 3 hours.', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['LIFU', 'Neuromodulation', 'Seizure'], 'conditions': ['Epilepsy (Treatment Refractory)', 'Epilepsy Comorbidities']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of medically refractory focal epilepsy of mesial temporal onset\n* RNS system implantation in the hippocampus\n* Prior MRI and CT of the head\n* Able to consent for themselves\n* Internet access\n\nExclusion Criteria:\n\n* TBI (ongoing, or in the prior 6 months)\n* Currently pregnant or breastfeeding\n* Progressive diseases - such as autoimmune epilepsies or diagnosis of a progressive neurological disorder\n* Status epilepticus within one year of study start\n* History of suicidal ideation or attempts in the last 6 months'}, 'identificationModule': {'nctId': 'NCT07353918', 'briefTitle': 'Low-Intensity Focused Ultrasound Neuromodulation for Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Carilion Clinic'}, 'officialTitle': 'Neuromodulation Using Low-intensity Focused Ultrasound for Potential Treatment for Medically Refractory Temporal Lobe Epilepsy', 'orgStudyIdInfo': {'id': 'IRB-24-2194'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LIFU- real', 'description': 'Low-intensity focused ultrasound will be applied to the entorhinal cortex in a pre/post design.', 'interventionNames': ['Device: Low-intensity Focused Ultrasound']}, {'type': 'SHAM_COMPARATOR', 'label': 'LIFU - Sham', 'description': 'Sham Low-intensity focused ultrasound will be applied to the entorhinal cortex in a pre/post design.', 'interventionNames': ['Device: Sham']}], 'interventions': [{'name': 'Low-intensity Focused Ultrasound', 'type': 'DEVICE', 'description': 'focused ultrasound transducer.', 'armGroupLabels': ['LIFU- real']}, {'name': 'Sham', 'type': 'DEVICE', 'description': 'Sham application of LIFU - energy blocked. Targeted to the same target as intervention.', 'armGroupLabels': ['LIFU - Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24016', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Fralin Biomedical Research Institute at VTC', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}], 'overallOfficials': [{'name': 'Aashit Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carilion Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carilion Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}