ET Stigma Response to Tremor Suppression

NCT07430761 | Recruiting

• 1 other identifier: STU20250223
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Action Tremor; Stigma, Social

Keywords

Essential tremor; stigma; thalamotomy; high intensity focused ultrasound

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Tremor Disability Scale - Revised

  change from baseline before thalamotomy to 12 months after thalamotomy

• TETRAS - Performance Scale

  change from baseline before thalamotomy to 12 months after thalamotomy

Study Arms (1)

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

Interventions

stereotactic thalamotomy with focused ultrasound PROCEDURE

stereotactic thalamotomy with high intensity focused ultrasound, guided by four-tract tractography

ET for thalamotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patient declines to participate in this observational study

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Soouthwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Tremor; Social Stigma; Essential Tremor

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior; Movement Disorders; Central Nervous System Diseases

Study Officials

• Padraig E O'Suilleabhain, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Padraig E O'Suilleabhain, MD

CONTACT

2146482943; padraig.osuilleabhain@utsouthwestern.edu

Padraig E O'Suilleabhain

CONTACT

2146482943

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)