Using focused ultrasound to treat drug-resistant epilepsy
Focused Ultrasound for Drug-resistant Epilepsy
This study is testing whether focused ultrasound can help people with drug-resistant epilepsy by reducing their seizures when other medications haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Taipei Veterans General Hospital, Taiwan Government |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06292494 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and above with localized refractory epilepsy who have not responded to at least two anti-seizure medications.
Not a fit: Patients with contraindications to MRI or those who cannot tolerate MRI scans will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive treatment option for patients with drug-resistant epilepsy, potentially reducing seizure frequency and improving quality of life.
How similar studies have performed: While focused ultrasound is a novel approach in this context, previous studies have shown promising results in using FUS for various neurological conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 20 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 this trial is running
Taipei
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.