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Epilepsy (Treatment Refractory)Phase 1NCT07249190

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.

A Phase 1 study testing MR-guided Focused Ultrasound Therapy in people with Epilepsy (Treatment Refractory), run by Chinese PLA General Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Epilepsy (Treatment Refractory)
What is being tested?
MR-guided Focused Ultrasound Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
1 Dec 2025to 30 Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female aged no less than 20 years old; Capable of signing the informed consent form and able to attend all study visits; Diagnosed as drug-resistant epilepsy by an epilepsy specialist; The subject's epilepsy is ineffective to the adequate use of at least two antiepileptic drugs, one of which must be a first-line drug. Adequate drug use is defined as the therapeutic dose of each drug or the occurrence of side effects with the increase of drug dose; Capable of communicating during the operation; Wechsler Adult Intelligence Scale (WAIS) score ≥ 70; The average number of epileptic seizures is ≥ 3 per month within 3 months before enrollment. The drug dose remains stable within 3 months before enrollment; The anterior nucleus of thalamus is identifiable on MRI (structural T1 and T2 images); Willing and able to keep an epileptic seizure diary.

Who cannot join

  • The frequency of epileptic seizures is < 3 times per month within 3 months before the subject is enrolled; The subject's Wechsler Adult Intelligence Scale (WAIS) score < 70; The subject cannot maintain the drug dose within 3 months after receiving treatment; The subject has epilepsy caused by previous infection (such as herpes virus); The subject has idiopathic epilepsy (Lennox-Gastaut syndrome, drop attacks); The subject is pregnant or lactating;
  • The subject has the following manifestations of unstable cardiac function:
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Longsheng Pan contact

86+13901365622

panls301@163.com

About this study

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.

Being tested
MR-guided Focused Ultrasound Therapy
Medical subject headings
Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MR-guided Focused Ultrasound TherapyProcedure or surgery

    MR-guided Focused Ultrasound Therapy focusing Anterior Nucleus of the thalamus

Study groups in NCT07249190
Study groupRoleWhat they receive
MR-guided Focused Ultrasound Treating EpilepsyExperimentalNot described
Receives: Procedure: MR-guided Focused Ultrasound Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

    Evaluate the incidence of adverse events (AEs) within 2 years after treatment with the investigational medical device.

    Measured: From enrollment to the end of treatment at 1 year

Secondary outcomes (1)
  1. Efficacy

    The efficacy evaluation indicator is the frequency of epileptic seizures, and the data are collected through the epilepsy seizure diary. Quality of life will be measured using the Quality of Life in Epilepsy Inventory-31 (QOLIE-31).

    Measured: From enrollment to the end of treatment at 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2025
  2. Study start1 Dec 2025 (estimated)
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
MRgFUS treating epilepsy
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07249190
Sponsor's protocol ID
301EP
Status last verified
Nov 2025
First submitted
18 Nov 2025
Last updated
25 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MR-guided Focused Ultrasound Therapy in people with Epilepsy (Treatment Refractory), run by Chinese PLA General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Longsheng Pan (86+13901365622, panls301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: From enrollment to the end of treatment at 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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