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NCT06388707 · ClinicalTrials.gov registry record · Phase 1
A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy
A Phase 1 study of Epilepsy and Drug Resistant Epilepsy, sponsored by NaviFUS Corporation.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 3
- Study locations
NCT06388707: Recruiting Phase 1 study of Epilepsy and Drug Resistant Epilepsy, sponsored by NaviFUS Corporation.
NCT06388707 is a Phase 1 study of Epilepsy and Drug Resistant Epilepsy that is actively recruiting participants, run by NaviFUS Corporation. The registered enrollment target is 8 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06388707, a Phase 1 study of Epilepsy and Drug Resistant Epilepsy, is actively recruiting participants, sponsored by NaviFUS Corporation.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 3
- Study locations
Study Summary
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).
Primary Outcome
The incidence and severity of AEs associated with LIFU neuromodulation in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy.
Conditions Studied
Interventions
- DEVICE NaviFUS System
Study Locations (3)
California
- Stanford University School of Medicine - Palo Alto
Massachusetts
- Brigham and Women's Hospital - Boston
Virginia
- University of Virginia School of Medicine - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2024-09-13 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 1 |
What NCT06388707 shows while recruiting
NCT06388707 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which NaviFUS System is the first listed.
NCT06388707 reports a single indexed study location in California, Massachusetts, Virginia.
Frequently Asked Questions
What is clinical trial NCT06388707 about?
NCT06388707 is a clinical study titled "A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy". 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 ...
What is the current status of trial NCT06388707?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2024-09-13. Estimated completion is 2025-12-31.
What conditions does trial NCT06388707 study?
This clinical trial studies the following conditions: Epilepsy, Drug Resistant Epilepsy.
What interventions are being tested in trial NCT06388707?
The interventions under investigation include: NaviFUS System (DEVICE).
Who is sponsoring clinical trial NCT06388707?
This trial is sponsored by NaviFUS Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06388707 being conducted?
This trial has 3 study locations across California, Massachusetts, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Epilepsy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06388707's enrollment target sits among peer trials
8 151st of 160 higher than 8 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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