A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy

Part of paid clinical trials in Palo Alto, California.

Sponsor
NaviFUS Corporation
Study ID
NCT06388707
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NaviFUS System — DEVICE
    FUS treatment will be conducted with following exposure parameters: intracranial spatial-peak temporal-average intensity (ISPTA) ceiling level: 2.8 W/cm2, burst length: 3 ms, duration: max. three consecutive 10-minute FUS exposures with two 5-minute intermission intervals.

Study Details

This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE).

Key Dates

Start date
Sep 13, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FUS treatment

Primary Outcome Measure

Adverse events (AEs) [ Time Frame: up to 23 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicinePalo AltoCalifornia94305
Robert Fisher, M.D., Ph.D.
Brigham and Women's HospitalBostonMassachusetts02115
Ellen Bubrick, M.D.
University of Virginia School of MedicineCharlottesvilleVirginia22903
Nathan Fountain, M.D.

Find similar trials in Palo Alto, CA

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
Stanford University School of Medicine· Palo Alto, CABrigham and Women's Hospital· Boston, MAUniversity of Virginia School of Medicine· Charlottesville, VA

Related Studies