NCT06492720 A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
| NCT ID | NCT06492720 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NaviFUS Corporation |
| Condition | Drug Resistant Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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Brief Summary
This will be a prospective, pilot, open-label, two-arm, parallel-group, randomized study to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant epilepsy (DRE).
Eligibility Criteria
Inclusion Criteria: 1. Male or female patients aged over than and equal to 18 years old. 2. Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry. 3. Epileptogenic focus (or foci) is determined by comprehensive presurgical evaluation. 4. At least 4 focal-onset seizures with objectively visible or significantly disabling manifestations in the 8-week baseline and at least one seizure per month in the baseline. 5. Willing and able to sign written informed consent and be able to comply with the study protocol during the study period. Exclusion Criteria: 1. Patients with concurrent active psychiatric or mood disorders that have been assessed to interfere with participation in the study. 2. Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, or deep brain stimulation (DBS). 3. The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.
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