Recruiting

Thalamotomy

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07430761

Conditions

Action Tremor

Stigma, Social

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

stereotactic thalamotomy with focused ultrasound

Study Details

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

Study ID

NCT07430761

Start date

Jan 1, 2025

Status verified date

Feb, 2026

Completion date

Aug 30, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

220 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

stereotactic thalamotomy with focused ultrasound

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

Primary outcome measure

  • ET stigma psychological distress [ Time Frame: change from baseline before thalamotomy to 12 months after thalamotomy ]
  • ET stigma social dysfunction [ Time Frame: change from baseline before thalamotomy to 12 months after thalamotomy ]

Central Contacts and Locations

Central contacts

Padraig E O'Suilleabhain

2146482943

Locations

University of Texas Soouthwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Padraig E O'Suilleabhain, MD

214-648-8737

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Feb 24, 2026

Last verified

Feb, 2026

Keywords

  • Essential tremor
  • stigma
  • thalamotomy
  • high intensity focused ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-02-24.