A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment fo… (NCT06492720) | Clinical Trial Compass
RecruitingNot Applicable
A Pilot Study to Evaluate the Efficacy and Safety of NaviFUSâ„¢ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
Taiwan16 participantsStarted 2024-09-01
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male or female patients aged over than and equal to 18 years old.
✓. Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry.
✓. Epileptogenic focus (or foci) is determined by comprehensive presurgical evaluation.
✓. 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.
✓. Willing and able to sign written informed consent and be able to comply with the study protocol during the study period.
Exclusion criteria
✕. Patients with concurrent active psychiatric or mood disorders that have been assessed to interfere with participation in the study.
✕. Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, or deep brain stimulation (DBS).
✕. The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), wounds, or atrophy of the scalp.
✕. Image documented calcified lesion in the FUS exposure path.
✕. Abnormal coagulation profile:
✕. Platelet (PLT) \< 100,000/μL.
✕
What they're measuring
1
Changes of seizure frequency after treatment compared to baseline