Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT06292494
Eligibility 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06292494
Study Brief:
Protocol Section:
NCT06292494