A Study to Evaluate the Safety and Effectiveness of Magnetic Resonance-Guided Ultrasound Ablation… (NCT07249190) | Clinical Trial Compass
Not Yet RecruitingPhase 1
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.
20 participantsStarted 2025-12-01
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Unstable angina pectoris under medication;
. Medical records of myocardial infarction within 6 months before entering the study;
. Congestive heart failure that is not effectively controlled or is deteriorating;
. History of arrhythmia with hemodynamic disturbance;
. Patients with implanted cardiac pacemakers;
. Severe hypertension (diastolic blood pressure still \> 100 mmHg after drug control); The subject exhibits behaviors consistent with alcohol addiction or substance abuse; History of abnormal systemic or intracranial hemorrhage; History of coagulation dysfunction: PLT \< 100,000/μl, PT \> 14 sec or PTT \> 36 sec, and INR \> 1.3; Use of anticoagulants (such as warfarin) or antiplatelet drugs (such as aspirin) within one week before surgery, or use of drugs that can increase the risk of bleeding (such as bevacizumab) within one month before focused ultrasound surgery; The subject has cerebrovascular diseases, including but not limited to: intracranial aneurysm, dural arteriovenous malformation (AVM), stroke, intracranial atherosclerotic disease, dural arteriovenous fistula (AVF), etc.; The subject has a brain tumor; The subject has severe abnormal brain structure; Previous corpus callosotomy, VNS, DBS, or stereotactic ablation; Implants in the skull or intracranial cavity; More than 30% of the head area through which the ultrasound irradiation path passes is covered by scars/scalp diseases (such as eczema) or scalp atrophy; The subject has a history of claustrophobia; The overall Skull Density Ratio (SDR) calculated by the subject during screening is less than 0.40 (±0.05); Unable to tolerate the long-term supine and stationary posture required during treatment (about 2-3 hours); Currently participating in another clinical research project; Unable to communicate with researchers and treatment staff; The subject is considered unsuitable for surgery or the study, which may include but is not limited to the following situations: the researcher deems that the subject has any medical, social, or psychological problems that may complicate the evaluation of the study process; The subject had suicidal thoughts within one month before enrollment; The subject has a clinically significant neurological disease other than epilepsy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety
Timeframe: From enrollment to the end of treatment at 1 year