Action Tremor, Stigma, Social
Conditions
Keywords
Essential tremor, stigma, thalamotomy, high intensity focused ultrasound
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.
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
PROCEDUREstereotactic thalamotomy with focused ultrasound
stereotactic thalamotomy with high intensity focused ultrasound, guided by four-tract tractography
Sponsors
University of Texas Southwestern Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ET stigma psychological distress | change from baseline before thalamotomy to 12 months after thalamotomy | Psychological distress related to other people's reaction to their tremor. |
| ET stigma social dysfunction | change from baseline before thalamotomy to 12 months after thalamotomy | Social avoidance and maladaptive behaviors related to other people's reaction to tremor. |
Countries
United States
Contacts
CONTACTPadraig E O'Suilleabhain, MD
CONTACTPadraig E O'Suilleabhain
PRINCIPAL_INVESTIGATORPadraig E O'Suilleabhain, MD
University of Texas Southwestern Medical Center
Outcome results
None listed