NCT07430761 ET Stigma Response to Tremor Suppression
| NCT ID | NCT07430761 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Action Tremor |
| Study Type | OBSERVATIONAL |
| Enrollment | 220 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 220 participants in total. It began in 2025-01-01 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Padraig E O'Suilleabhain, MD
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT07430761 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Action Tremor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07430761 currently recruiting?
Yes, NCT07430761 is actively recruiting participants. Contact the research team at padraig.osuilleabhain@utsouthwestern.edu for enrollment information.
Where is the NCT07430761 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT07430761 clinical trial?
NCT07430761 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Padraig E O'Suilleabhain, MD at University of Texas Southwestern Medical Center. The trial plans to enroll 220 participants.