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EpilepsyEPIFUSNCT07591350

Assessment of MRI-guided HIFU for Patients With Drug-resistant Focal Epilepsy

A study testing MR-guided HIFU thermoablation, EEG and MRI in people with Epilepsy, run by Assistance Publique - Hôpitaux de Paris.

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 goal of this clinical trial is to assess the feasibility, safety, and tolerance of MRI-guided High-Intensity Focused Ultrasound (HIFU) for the treatment of drug-resistant focal epilepsy in adult patients with MRI-visible brain lesions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Epilepsy
What is being tested?
MR-guided HIFU thermoablation, EEG and MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
No sites listed yet
Study dates
Sep 2026to Dec 2029
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years old
  • Patient with drug-resistant epilepsy according to ILAE definition
  • Patient presenting lesional image(s) on morphological MRI responsible for epilepsy according to clinical and electrophysiological evaluation, +/-PET+/- SPECT+/-sEEG
  • Patients for whom neurosurgical treatment by craniotomy is not possible: deep-seated lesions, lesions in the eloquent area, patient reluctance to have a surgical procedure with craniotomy, contraindication to general anesthesia
  • Patient affiliated to a social security scheme
  • The patients signed an informed consent form.

Who cannot join

  • Drug-sensitive epilepsy
  • Patients exhibiting suboptimal adherence to medication
  • Individuals under legal protective measures
  • Patients presenting contraindications to Magnetic Resonance Imaging (MRI), such as the presence of metal fragments, allergy to gadolinium, etc.
  • Patients with serious and uncontrolled psychiatric disorders
  • Pregnant women. Women of reproductive capacity were mandated to use oral contraceptives throughout the study duration.
Show all 19Show fewer
  • Contraindications related to ExAblate treatment:
  • patients with implants in the brain or skull.
  • patients where it is not possible to avoid energy-absorbing structures or sensitive tissues (e.g., skull density ratio <0.35, areas of anterior brain shunts, surgical clamps, or other hard implants) on the path of the ultrasound beam.
  • patients diagnosed with another brain disease (e.g., malignant brain tumors or intracranial aneurysms).
  • patients with a history of cerebral hemorrhage, and stroke within the last year.
  • patients taking medications that are predisposed to bleeding and have not stopped for two weeks before the procedure.
  • patients with severe hypertension that cannot be controlled with medication (diastolic blood pressure >100 mmHg).
  • patients who could not communicate with the physician during the treatment.
  • patients with unstable cardiac conditions.
  • patients with history of abnormal bleeding, intracranial hemorrhage, coagulopathy, or documented risk factors for intraoperative or postoperative bleeding or coagulopathy.
  • patients with cerebrovascular disease (multiple strokes or strokes within six months).
  • patients with risk factors for intraoperative or postoperative bleeding.
  • patients with significant healing in an area located on the path of the intended passage of energy to the treatment area.

Trial locations and contacts

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

Bertrand Mathon, MD PhD contact

+ 33 1 42 16 34 08

bertrand.mathon@aphp.fr

About this study

Official title: Clinical and Radiological Assessment of MRI-guided High-intensity Focused Ultrasound for Patients With Drug-resistant Focal Epilepsy

The goal of this clinical trial is to assess the feasibility, safety, and tolerance of MRI-guided High-Intensity Focused Ultrasound (HIFU) for the treatment of drug-resistant focal epilepsy in adult patients with MRI-visible brain lesions.

The main question it aims to answer is whether HIFU can safely and effectively achieve the target ablative temperature (≥52 °C) within epileptogenic lesions, thereby enabling successful thermal ablation of the epileptogenic focus.

This pilot, single-center study is single arm, prospective, non-comparative and uncontrolled. This will take place over a period of 24 months. After information (V1), inclusion (V2) and presurgical (V3) visits, a surgical visit will be performed during hospitalization in the neurosurgery department (V4) for HIFU therapy and 5 follow-up consultation visits (V5, V6, V7, V8, and V9 to J7, M1, M3, M6, and M12).

Read the detailed description

Epilepsy is a common, long-lasting neurological disorder with significant social ramifications. In France, it is estimated that over 500,000 individuals are affected by epilepsy, with 50,000 experiencing drug-resistant partial epilepsy. Approximately 10,000 patients with drug-resistant partial epilepsy may benefit from neurosurgical treatment to excise their epileptogenic focus. However, only 300 operations are performed annually in France. Epilepsy surgery not only has medical benefits (with 50-80% of operated patients being seizure-free), but also reduces the risk of excess mortality in this population. Furthermore, it is a cost-effective solution, as drug-resistant epileptic patients can cost up to $138,000 in treatment and monitoring throughout their lifetime. High-Intensity Focused Ultrasound (HIFU) is a noninvasive method that uses heat to destroy brain lesions, leading to coagulation and necrosis of the lesion under control. It has been successfully used to treat essential tremors, Parkinson's disease, and neuropathic pain, and may be used to treat epilepsy lesions that are inaccessible to conventional surgery, located in eloquent areas, or in patients with contraindications to general anesthesia. The goal of this study is to assess the feasibility, tolerance, and safety of HIFU use in lesions responsible for drug-resistant epilepsy, as this represents the first use of HIFU for this indication.

Main objective : To assess the feasibility of employing HIFU-based thermoablation for the treatment of drug-resistant epilepsy caused by intracerebral lesions.

Conditions
Epilepsy
Being tested
MR-guided HIFU thermoablation, EEG, MRI
Keywords
Epilepsy, HIFU, drug-resistant epilepsy, thermoablation, Epilepsy surgery
Medical subject headings
Epilepsy, Drug Resistant Epilepsy

What participants receive

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

  • MR-guided HIFU thermoablationProcedure or surgery

    • HIFU-based thermoablation: non-invasive brain tissue ablation by a MRI-guided transcranial ultrasound (MRgFUS) system. • Installation of a stereotaxy frame: 4 cranial skin points under local anesthesia with Xylocaine, Perfalgan IV 2g in IVL, usual brushing protocol with iodized alcohol, and removal of stereotaxy frame • MRI with contrast agent administration acquisition and definition of the area to be treated and ultrasound parameters by neurosurgeons, neuroradiologists, and physicists. • Realization of thermoablation under real-time control using MRI and clinical control.

  • EEGDiagnostic test

    Surface EEG: assessment of residual seizures and interictal epileptiform activity.

  • MRIDiagnostic test

    Brain MRI in the Neuroradiology department to monitor lesion volume, possible reactive edema, and possible mass effect. The imaging protocol will include 3D T1, 3D T2, 3D FLAIR, SWI, Diffusion and 3D T1 after gadolinium injection sequences.

Study groups in NCT07591350
Study groupRoleWhat they receive
Assigned InterventionsExperimentalNot described
Receives: Procedure: MR-guided HIFU thermoablation; Diagnostic Test: EEG; Diagnostic Test: MRI

What is being measured

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

  1. Target ablative temperature

    Achievement of the target ablative temperature (at least one timepoint at 52 °C (15 °C above body temperature)) on calorimetric MRI sequences performed in real time during HIFU treatment (real-time quantitative measurements + CSV data extracted at the end of the procedure).

    Measured: During the procedure between 60 and 75 days after inclusion

Secondary outcomes (13)

  1. Post-intervention complications of grade≥2

    Clinical safety: Post-intervention complications at D30 of grade≥2 (complications requiring therapeutic intervention or after-effects or death) according to Mathon et al., Journal of Neurology, 2015.

    Measured: From day 0 to day 30 after the procedure.

  2. Morphological MRI

    Evaluation measured by morphological MRI corresponding to necrosis induced by MRI (axes, volume, ablation margins).

    Measured: From the day of the procedure up to 12 months after the procedure.

  3. Thermometric MRI monitoring during HIFU thermoablation

    Measured: At D0 during the procedure

  4. Cumulative thermal dose during HIFU thermoablation

    Measured: At D0 during the procedure

  5. ILAE classification

    Measured: At 12 months after the procedure

  6. Frequency of epileptic seizures

    Number of epileptic seizures using the seizure diary starting

    Measured: From inclusion up to 12 months after the procedure

  7. Intensity of epileptic seizures

    Intensity of epileptic seizures using the seizure diary

    Measured: From inclusion up to 12 months after the procedure

  8. Change in antiepileptic treatment

    Number of antiepileptic drugs, modification in antiepileptic dose.

    Measured: From inclusion up to 12 months after the procedure

  9. Antiepileptic effectiveness EEG

    Surface EEG in comparison with pretreatment EEG (seizures, interictal abnormalities).

    Measured: From inclusion up to 12 months after the procedure

  10. Neuropsychological evaluation

    Change from pre-treatment assessment performed in the inclusion work-up of the neuropsychological assessment at M12

    Measured: At inclusion and at 12 months

  11. Evaluation of quality of life

    Mean change of global score of quality of life according to the quality of life in epilepsy inventory-31 (QOLIE-31) questionnaire from pre-treatment assessment during the inclusion work-up at M12.

    Measured: At inclusion and at 12 months

  12. MRI-assessed radiological safety

    Thermometric MRI monitoring on D0, induced edema on D7 and D30

    Measured: From the day of the procedure up to days 30 after the procedure

  13. Adverse events related to HIFU treatment

    Frequency, intensity, and severity of adverse effects collected during treatment and follow-up period

    Measured: From the D0 the day of procedure up to 12 months after the procedure

Timeline

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

  1. First posted15 May 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionNov 2028 (estimated)
  4. Study completionDec 2029 (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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This pilot, single-center study is single arm, prospective, non-comparative and uncontrolled.
Masking
None (open label)
Enrolment
13 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07591350
Sponsor's protocol ID
APHP240803
Acronym
EPIFUS
Status last verified
May 2026
First submitted
16 Apr 2026
Last updated
15 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing MR-guided HIFU thermoablation, EEG and MRI in people with Epilepsy, run by Assistance Publique - Hôpitaux de Paris.

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 6 inclusion and 19 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 15 May 2026. 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.

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 Bertrand Mathon, MD PhD (+ 33 1 42 16 34 08, bertrand.mathon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target ablative temperature (time frame: During the procedure between 60 and 75 days after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07591350.

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 15 May 2026.

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