A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy
Phase 1/2
8
about 1.3 years
18+
3 sites in CA, MA, VA
What this study is about
This trial is testing the safety, tolerability, and early effectiveness of low-intensity focused ultrasound neuromodulation using a device called NaviFUS System in people with drug-resistant epilepsy. The treatment will be given for 474 days.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Use NaviFUS System
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Adverse events (AEs)
Secondary: Change from baseline in electroencephalography (EEG) epileptiform discharges, Change from baseline in seizure frequency, Changes from baseline in Beck Depression Inventory (BDI-II)
therapeutic
Neurology