An observational study in Action Tremor and Stigma, Social, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by University of Texas Southwestern Medical Center · Observational
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.
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.
158 studies on the registry are indexed under Tremor; 44 are open to participants now.
This study's planned enrollment of 220 is above the median of 74 across 45 observational studies indexed under Tremor.
Browse Tremor studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
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Patients who are scheduled to undergo stereotactic thalamotomy guided by four-tract tractography at the University of Texas Southwestern Medical Center for the treatment of Essential Tremor (ET). As is standard of practice, the diagnosis of ET and the judgment that this procedure is medically necessary will have been made by a movement disorder specialist. Once the procedure is scheduled, patients are invited to participate in this observational prospective study of effects on ET stigma.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with diagnosis of problematic essential tremor refractory to pharmacologic treatment who are to undergo stereotactic thalamotomy with high intensity focused ultrasound.
Procedure: stereotactic thalamotomy with focused ultrasound
stereotactic thalamotomy with high intensity focused ultrasound, guided by four-tract tractography
ET stigma psychological distress
Psychological distress related to other people's reaction to their tremor.
Time frame: change from baseline before thalamotomy to 12 months after thalamotomy
ET stigma social dysfunction
Social avoidance and maladaptive behaviors related to other people's reaction to tremor.
Time frame: change from baseline before thalamotomy to 12 months after thalamotomy
Tremor Disability Scale - Revised
self-assessed impact of tremor on skilled manual function
Time frame: change from baseline before thalamotomy to 12 months after thalamotomy
TETRAS - Performance Scale
tremor severity measured objectively
Time frame: change from baseline before thalamotomy to 12 months after thalamotomy
Plan to share: No — deidentified data will be shared on request with researchers employed by accredited third level institutions.
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for May 2027, 28 months after the start.
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