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.
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.
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.
- Conditions
- Epilepsy (Treatment Refractory)
- 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 group | Role | What they receive |
|---|---|---|
| MR-guided Focused Ultrasound Treating Epilepsy | Experimental | Not 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.
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)
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.
- First posted25 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy (Treatment Refractory)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Longsheng Pan, Chinese PLA General Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07249190
- Acronym / sponsor ID
- 301EP
- Conditions
- Epilepsy (Treatment Refractory)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- MRgFUS treating epilepsy
| Arm | Type | Receives |
|---|---|---|
| MR-guided Focused Ultrasound Treating Epilepsy | Experimental | Procedure: MR-guided Focused Ultrasound Therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-guided Focused Ultrasound TherapyMR-guided Focused Ultrasound Therapy focusing Anterior Nucleus of the thalamus | Procedure or surgery | MR-guided Focused Ultrasound Treating Epilepsy |
Primary outcome
Safety
Time frame: From enrollment to the end of treatment at 1 year
Evaluate the incidence of adverse events (AEs) within 2 years after treatment with the investigational medical device.
1 secondary outcome
Efficacy
Time frame: From enrollment to the end of treatment at 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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.