NCT07430761

ET Stigma Response to Tremor Suppression

ET Stigma Response to Tremor Suppression With Focused Ultrasound Thalamotomy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 220 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Essential Tremor (ET) is prevalent, affecting approximately 3% of the adult population. Involuntary shaking of the hands during action is a prominent feature, interfering with feeding and writing and other manual tasks. The involuntary movement is visible to observers, some of whom misinterpret the shakiness as manifestation of anxiety or instability, while some other observers attribute it to alcohol or drug use. The psychological effects of resulting stigma on quality of life for people with ET can rival the physical difficulties caused by the condition. For this study, we propose to measure 1 year after effective tremor suppression following thalamotomy with high intensity focused ultrasound changes from baseline in psychological distress and social dysfunction related to ET stigma, and to correlate change from baseline with improvement in functional status related to tremor and in objective measures of tremor severity. We hope to discover that ET stigma is largely reversible when tremor is effectively treated, and we aim to learn what degree of tremor suppression correlates with substantial psychological relief. We will also determine if ET stigma is predominantly helped by unilateral dominant-hand treatment, or if the second side treatment is necessary to accomplish most benefit.

Detailed description

Study procedures: Subjects will complete the following three surveys on two occasions i.e. at baseline, hours or days before thalamotomy, and again 12 months after the procedure (with a window of 11 to 18 months). Completing the three surveys takes approximately 5 minutes. 1. The ET-stigma distress scale which has 11 items each with 5 response options ranging from "strongly disagree" to "strongly agree" 2. the ET stigma dysfunction scale which has 5 items each with 3 response options ranging from "not at all or rarely" to "frequently" 3. the Tremor Disability Scale-Revised with 20 items each with 4 response options ranging from "no difficulty" to "cannot perform the task".

Conditions

• Action Tremor
• Stigma, Social

Interventions

Type	Name	Description
PROCEDURE	stereotactic thalamotomy with focused ultrasound	stereotactic thalamotomy with high intensity focused ultrasound, guided by four-tract tractography

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-05-30
• Completion: 2027-08-30
• First posted: 2026-02-24
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States