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NCT07599592 · ClinicalTrials.gov registry record · Early Phase 1
Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor
A Early Phase 1 study, sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT07599592 is a Early Phase 1 study that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 20 participants.
The verdict
NCT07599592, a Early Phase 1 study, is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This open-label pilot study will evaluate the safety, tolerability, feasibility, and preliminary efficacy of repeated low-intensity focused ultrasound pulsation (LIFUP) targeting the ventral intermediate nucleus (Vim) of the thalamus in patients with Essential Tremor (ET). Twelve adults with clinically diagnosed ET will undergo six LIFUP treatment sessions over approximately two weeks using the BrainSonix BX Pulsar 1002 system. Tremor severity will be assessed using clinician-rated scales (TETRAS and FTM), patient-reported quality-of-life measures (QUEST), and objective accelerometry before and after treatment sessions, with additional follow-up visits at one and three months post-treatment. MRI scans will be performed at baseline and after the final treatment session to monitor safety. The study aims to characterize whether non-ablative focused ultrasound can safely and transiently modulate tremor-related thalamic circuits and provide preliminary evidence supporting future controlled trials of LIFUP for ET.
Interventions
- DEVICE Low Intensity Focused Ultrasound (LIFU)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-05-01 |
| Est. Completion | 2027-06-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07599592
The ClinicalTrials.gov registry entry for NCT07599592 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Low Intensity Focused Ultrasound (LIFU) is the first listed.
NCT07599592 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07599592 about?
NCT07599592 is a clinical study titled "Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor". This open-label pilot study will evaluate the safety, tolerability, feasibility, and preliminary efficacy of repeated low-intensity focused ultrasound pulsation (LIFUP) targeting the ventral intermediate nucleus (Vim) of the thalamus in patients with Essential Tremor (ET). Twelve adults with clinica...
What is the current status of trial NCT07599592?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2026-05-01. Estimated completion is 2027-06-01.
What interventions are being tested in trial NCT07599592?
The interventions under investigation include: Low Intensity Focused Ultrasound (LIFU) (DEVICE).
Who is sponsoring clinical trial NCT07599592?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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