NCT06388707

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

A Prospective, Open-label, Single-arm, Multi-center, Pilot Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Unilateral or Bilateral Temporal Lobe Epilepsy

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: NaviFUS Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The study aims to demonstrate the safety and preliminary efficacy of LIFU neuromodulation in DR-TLE patients, showing its ability to decrease targeted neuronal activity and alleviate epileptic seizures. Patients diagnosed with epilepsy who meet all eligibility criteria may participate in this study by providing informed consent, either in person or through their legal representative. Eligible patients will undergo a 2-month baseline observation screening period and will be asked to keep a 8-week seizure diary. This diary will serve as a baseline prior to treatment and will continue to be recorded throughout the treatment and follow-up period. This study will enroll a maximum of 8 eligible patients through competitive enrollment. Patients will receive a total of 6 FUS treatments over 3 consecutive weeks using assigned ultrasound exposure doses generated by the NaviFUS System. Following treatment, there will be a 12-week follow-up period. Patients will be allowed concomitant use of anti-seizure medications (ASMs) throughout the whole study period.

Conditions

• Drug Resistant Epilepsy
• Epilepsy
• Seizures, Focal
• Seizure
• Seizure Disorder

Interventions

Type	Name	Description
DEVICE	NaviFUS System	FUS treatment will be conducted with following exposure parameters: intracranial spatial-peak temporal-average intensity (ISPTA) ceiling level: 2.8 W/cm2, burst length: 3 ms, duration: max. three consecutive 10-minute FUS exposures with two 5-minute intermission intervals.

Timeline

• Start date: 2024-09-13
• Primary completion: 2026-12-31
• Completion: 2027-05-31
• First posted: 2024-04-29
• Last updated: 2026-04-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study