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NCT Number: NCT07430761

ET Stigma Response to Tremor Suppression

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.

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Key information

Conditions

Action Tremor Behavior Central Nervous System Diseases Dyskinesias Essential Tremor Movement Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Social Behavior Social Stigma Stigma, Social Tremor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Soouthwestern Medical Center

Dallas, Texas, 75390, United States

Location status: Recruiting

Location contact

Padraig E O'Suilleabhain, MD

CONTACT

214-648-8737

About this study

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.

  • The ET-stigma distress scale which has 11 items each with 5 response options ranging from "strongly disagree" to "strongly agree"
  • the ET stigma dysfunction scale which has 5 items each with 3 response options ranging from "not at all or rarely" to "frequently"
  • the Tremor Disability Scale-Revised with 20 items each with 4 response options ranging from "no difficulty" to "cannot perform the task".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stereotactic thalamotomy with focused ultrasound

Procedure

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

Primary outcomes

  1. ET stigma psychological distress

    Time frame: change from baseline before thalamotomy to 12 months after thalamotomy

    Psychological distress related to other people's reaction to their tremor.

  2. ET stigma social dysfunction

    Time frame: change from baseline before thalamotomy to 12 months after thalamotomy

    Social avoidance and maladaptive behaviors related to other people's reaction to tremor.

Other outcomes

  1. Tremor Disability Scale - Revised

    Time frame: change from baseline before thalamotomy to 12 months after thalamotomy

    self-assessed impact of tremor on skilled manual function

  2. TETRAS - Performance Scale

    Time frame: change from baseline before thalamotomy to 12 months after thalamotomy

    tremor severity measured objectively

Study contacts

Contact information is provided by the study sponsor or research team.

Padraig E O'Suilleabhain

CONTACT

2146482943

Padraig E O'Suilleabhain, MD

CONTACT

[email protected]

2146482943

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

ET Stigma Response to Tremor Suppression With Focused Ultrasound Thalamotomy

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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