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Clinical Trial

Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor

NCT: NCT07599592 · RECRUITING

NCT IDNCT07599592
StatusRECRUITING
Start Date2026-05-01
Completion2027-06-01

Brief 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.

Frequently Asked Questions

What is Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor?

Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor is a clinical trial registered under NCT07599592. Current status: RECRUITING.

What is the status of NCT07599592?

The current status of NCT07599592 (Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor) is: RECRUITING.

When did Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor start?

Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor started on 2026-05-01.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.