ET Stigma Response to Tremor Suppression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: stereotactic thalamotomy with focused ultrasound.
- Who it may be relevant to
- Registry conditions: Action Tremor, Stigma, Social. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ET Stigma Response to Tremor Suppression With Focused Ultrasound Thalamotomy
Overview
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.
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".
Interventions
- Procedure stereotactic thalamotomy with focused ultrasound
stereotactic thalamotomy with high intensity focused ultrasound, guided by four-tract tractography
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- University of Texas Soouthwestern Medical Center — Dallas
Identifiers
NCT: NCT07430761 · STU20250223