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NCT06388707 · ClinicalTrials.gov record · last posted 2026-04-09

A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy

StatusRecruiting
PhasePhase 1/2
Started2024-09-13
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from the ClinicalTrials.gov record
This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE).

Amendment record 2 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 2 times since 2024-04-24; most recent amendment 2026-04-06. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2025-05-07
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT06388707
Lead Sponsor NaviFUS Corporation
Collaborators: NaviFUS US LLC
Conditions Drug Resistant Epilepsy, Epilepsy, Seizures, Focal, Seizure, Seizure Disorder
Enrollment 8 participants
Start Date 2024-09-13
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-09