ET Stigma Response to Tremor Suppression

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07430761
Status
Recruiting
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Conditions

  • Action Tremor
  • Stigma, Social

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 1, 2025
Status verified
Feb 2026
Primary completion
May 30, 2027
Completion
Aug 30, 2027

Study Design

Enrollment
220 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

  • Padraig E O'Suilleabhain, MD
    2146482943
    [email protected]
  • Padraig E O'Suilleabhain
    2146482943

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Soouthwestern Medical CenterDallasTexas75390
Padraig E O'Suilleabhain, MD
214-648-8737

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By research site
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