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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.

Not yet recruiting Phase 1 Last updated 25 November 2025
What this trial tests

Phase 1 trial testing MR-guided Focused Ultrasound Therapy in Epilepsy (Treatment Refractory) in 20 participants. Not yet recruiting.

Timeline
1 December 2025
Primary endpoint
30 November 2027
30 December 2027

Quick facts

Lead sponsorChinese PLA General Hospital
PhasePhase 1
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date1 December 2025
Primary completion30 November 2027
Estimated completion30 December 2027

Drugs / interventions tested

Conditions studied

Sponsor

Chinese PLA General Hospital

Who can join

20 and older, any sex, with Epilepsy (Treatment Refractory). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Epilepsy (Treatment Refractory)

Currently open trials in the same condition.

Other Chinese PLA General Hospital trials

Trials by the same sponsor.

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Data sources for this page

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