About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient declines to participate in this observational study
Trial population
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.
Trial design
Case-only
Prospective
Treatments tested in this trial
stereotactic thalamotomy with focused ultrasound
Procedure/Surgerystereotactic thalamotomy with high intensity focused ultrasound, guided by four-tract tractography
Treatment groups
Trial outcomes
Primary outcomes
ET stigma psychological distress
Psychological distress related to other people's reaction to their tremor.
ET stigma social dysfunction
Social avoidance and maladaptive behaviors related to other people's reaction to tremor.
Other outcomes
Tremor Disability Scale - Revised
self-assessed impact of tremor on skilled manual function
TETRAS - Performance Scale
tremor severity measured objectively
Sponsors and contacts
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