Using focused ultrasound to treat drug-resistant epilepsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of focused ultrasound (FUS) technology to treat patients with drug-resistant epilepsy. It aims to assess the safety and efficacy of the Exablate 4000 Transcranial MR-guided FUS System in reducing epileptic activity as measured by EEG recordings. The study will involve patients who have not responded to multiple anti-seizure medications and will evaluate the optimal parameters for FUS application. Participants will undergo a thorough preoperative examination and will be monitored for changes in seizure frequency following treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged 18 and above.
* Localized refractory epilepsy (ineffective with maximum doses of two or more anti-seizure medications).
* Seizure frequency records for at least one month prior to the trial.
* Patients who have undergone a complete preoperative examination, including EEG, MRI, and positron emission tomography (PET).
* Capable of undergoing high-resolution computed tomography (CT scan), and SDR (Skull Density Ratio) ≥ 0.3.
* Must have a body type suitable for entry into the magnetic resonance imaging (MRI) machine and be able to tolerate MRI scans.
* During the surgical procedure, communication with the physician and the expression of sensory perceptions are essential; general anesthesia is not required.
* Must be able to voluntarily press the stop button.
* Willing to undergo removal of hair from the treatment site.

Exclusion Criteria:

* This product is not suitable for individuals with contraindications related to MRI, such as those with metallic implants, those unable to undergo MRI, severe claustrophobia, or those with adverse reactions to contrast agents.
* Individuals with implants in the brain or skull, such as shunts, electrodes, hard brain membrane patches, or electrode plates, that cannot be avoided along the expected path of brain ultrasound.
* Patients along the expected path of brain ultrasound who cannot avoid structures or sensitive tissues with energy absorption (e.g., previous brain shunt surgery sites, surgical metal clips, or any hard implants).
* Patients with extensive scabbing along the expected path of brain ultrasound.
* Patients who have used contrast agents (e.g., MRI, ultrasound) within the past 24 hours before treatment.
* Patients with other high-risk brain disorders (e.g., intracranial aneurysm).
* Patients with intraoperative or postoperative bleeding risk:

  1. Those with a history of cerebrovascular disease (multiple strokes or strokes within the past six months) or a history of cerebral hemorrhage and stroke.
  2. Those with abnormal bleeding, intracranial bleeding, coagulation disorders, or a history of bleeding or clotting disorders, either during or after surgery.
* Patients taking or injecting anticoagulant medications such as aspirin, coumadin, heparin, novel oral anticoagulants (NOACs), etc., which may lead to prolonged bleeding. Medication should be discontinued for 3-7 days before treatment.
* Patients with severe uncontrolled hypertension (systolic blood pressure \> 180 mmHg after stable medication, diastolic blood pressure \> 100 mmHg).
* Patients unable to communicate with the physician during the treatment process.
* Unstable cardiac conditions (heart rate \> 180 beats/minute or \< 40 beats/minute; systolic blood pressure \> 180 mmHg or \< 90 mmHg).
* Substance abuse (use of illegal drugs or using medications in a manner not recommended by a physician or manufacturer) or alcohol addiction.
* Patients who have taken medications affecting the central nervous system within the past six months (e.g., central nervous system stimulants, sympathomimetic agents).
* Patients with psychological abnormalities (e.g., schizophrenia, severe depression, bipolar disorder).
* Individuals with severe head surface injuries or potential allergies to materials in contact with the head (such as conductive gels, head silicone membranes)

Where it's running

• Taipei Veterans General Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Principal investigator: Cheng-Chia Lee, MD. PhD. — Taipei Veterans General Hospital, Taiwan
• Study coordinator: Cheng-Chia Lee, MD. PhD.
• Email: cclee12@vghtpe.gov.tw
• Phone: +886-28752121

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Modified ketogenic diet for adults with drug-resistant epilepsy

  This study tests whether a modified ketogenic diet can help adults with drug-resistant epilepsy see fewer seizures and feel better overall.

  Recruiting Karolinska Institutet · Stockholm · NCT07878104

• Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy

  This study tests whether low intensity focused ultrasound can help reduce seizures in adults with drug‑resistant epilepsy.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07680842

• iVEAcare Neuromodulation System for drug‑resistant epilepsy: a feasibility look

  This study tests whether the iVEAcare neuromodulation system is safe and can help reduce seizures and improve quality of life in people with drug‑resistant epilepsy.

  Recruiting at 7 sites iVEAcare · Herston, Queensland and 6 other locations · NCT07640191

• Real-world use of the OneRF Ablation System for epilepsy

  This registry collects real-world outcomes and device performance from patients with drug-resistant epilepsy who are treated with SEEG-guided RF ablation using the OneRF system.

  Recruiting at 3 sites NeuroOne Medical Technologies Corporation · Miami, Florida and 2 other locations · NCT07546253

• Overnight Temporal Interference Stimulation for Temporal Lobe Epilepsy

  This study tests whether overnight, non-invasive temporal interference stimulation to the hippocampus can reduce seizure-related brain activity and improve sleep in adults with drug-resistant temporal lobe epilepsy.

  Recruiting Duke University · Durham, North Carolina · NCT07434986

• Biomarkers of Response to SEEG Thermocoagulation

  This study tests biomarkers to see if they predict how well SEEG-guided radiofrequency thermocoagulation helps people with drug-resistant focal epilepsy.

  Recruiting Assistance Publique Hopitaux De Marseille · Marseille · NCT07399327

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.