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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06388707
The ClinicalTrials.gov registry entry for NCT06388707 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (99% lower). The listed sponsor is NaviFUS Corporation, which has 2 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.