ET Stigma Response to Tremor Suppression

ET Stigma Response to Tremor Suppression With Focused Ultrasound Thalamotomy

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.

Study Overview

• Status: Recruiting
• Conditions: Stigma, Social; Action Tremor
• Intervention / Treatment: Procedure: stereotactic thalamotomy with focused ultrasound

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".

• Study Type: Observational
• Enrollment (Estimated): 220

Contacts and Locations

• Study Contact: Name: Padraig E O'Suilleabhain, MD; Phone Number: 2146482943; Email: padraig.osuilleabhain@utsouthwestern.edu
• Study Contact Backup: Name: Padraig E O'Suilleabhain; Phone Number: 2146482943

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Soouthwestern Medical Center
      • Contact: Padraig E O'Suilleabhain, MD; Phone Number: 214-648-8737

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are scheduled to undergo stereotactic thalamotomy guided by four-tract tractography at the University of Texas Southwestern Medical Center for the treatment of Essential Tremor (ET). As is standard of practice, the diagnosis of ET and the judgment that this procedure is medically necessary will have been made by a movement disorder specialist. Once the procedure is scheduled, patients are invited to participate in this observational prospective study of effects on ET stigma.

Description

Inclusion Criteria:

• People with ET as diagnosed by a movement disorder neurologist
• Tremor of sufficient severity and impact on quality of life so as to justify a lesional brain procedure
• Competent to consent to undergoing high intensity focused ultrasound thalamotomy targeted by 4-tract tractography
• Provide verbal informed consent to this study of ET stigma

Exclusion Criteria:

• Patient declines to participate in this observational study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ET for thalamotomy; Patients with diagnosis of problematic essential tremor refractory to pharmacologic treatment who are to undergo stereotactic thalamotomy with high intensity focused ultrasound.	Procedure: stereotactic thalamotomy with focused ultrasound; stereotactic thalamotomy with high intensity focused ultrasound, guided by four-tract tractography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ET stigma psychological distress	Psychological distress related to other people's reaction to their tremor.	change from baseline before thalamotomy to 12 months after thalamotomy
ET stigma social dysfunction	Social avoidance and maladaptive behaviors related to other people's reaction to tremor.	change from baseline before thalamotomy to 12 months after thalamotomy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tremor Disability Scale - Revised	self-assessed impact of tremor on skilled manual function	change from baseline before thalamotomy to 12 months after thalamotomy
TETRAS - Performance Scale	tremor severity measured objectively	change from baseline before thalamotomy to 12 months after thalamotomy

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Padraig E O'Suilleabhain, MD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: stigma; Essential tremor; high intensity focused ultrasound; thalamotomy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Dyskinesias; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Social Behavior; Tremor; Essential Tremor; Social Stigma
• Other Study ID Numbers: STU20250223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: deidentified data will be shared on request with researchers employed by accredited third level institutions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No