Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 8:54 PM
Study NCT ID:
NCT07430761
Status:
RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ET Stigma Response to Tremor Suppression
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
ET Stigma Response to Tremor Suppression With Focused Ultrasound Thalamotomy
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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".
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".
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: