NCT07249190

A Study to Evaluate the Safety and Effectiveness of Magnetic Resonance-Guided Ultrasound Ablation of the Anterior Nucleus of Thalamus for the Treatment of Drug-resistant Epilepsy.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The study "Safety and Efficacy Evaluation of MR-Guided Focused Ultrasound Anterior Thalamic Nucleus Ablation for Drug-Resistant Epilepsy" from Chinese PLA General Hospital, is a single-center, prospective, single-arm study. It uses a MR-guided Focused Ultrasound Therapy System and plans to recruit 20 patients with drug-resistant epilepsy who are ≥20 years old, have a WAIS score ≥70, an average of ≥3 monthly epileptic seizures in the 3 months before enrollment, and are refractory to at least 2 antiepileptic drugs (including 1 first-line drug), excluding those with unstable cardiac function, brain tumors, previous brain surgery history, etc. Anterior thalamic nucleus ablation is performed via MRgFUS, with multiple follow-ups from 48 hours to 2 years postoperatively. Safety is evaluated by the incidence of adverse events within 2 years, efficacy by seizure frequency recorded in epilepsy diaries and the QOLIE-31 scale. Statistical analysis is conducted using toolkits, while risks such as MRI-induced claustrophobia and CT radiation are controlled. It adheres to GCP and the Declaration of Helsinki to ensure data authenticity and subjects' rights. The technology provider is responsible for the normal operation of the device and providing 20 sets of treatment consumables.

Conditions

• Epilepsy (Treatment Refractory)

Interventions

Type	Name	Description
PROCEDURE	MR-guided Focused Ultrasound Therapy	MR-guided Focused Ultrasound Therapy focusing Anterior Nucleus of the thalamus

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-11-30
• Completion: 2027-12-30
• First posted: 2025-11-25
• Last updated: 2025-11-25