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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ET for thalamotomy | Patients with diagnosis of problematic essential tremor refractory to pharmacologic treatment who are to undergo stereotactic thalamotomy with high intensity focused ultrasound. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic thalamotomy with focused ultrasound | Procedure | stereotactic thalamotomy with high intensity focused ultrasound, guided by four-tract tractography |
|
| Measure | Description | Time Frame |
|---|---|---|
| ET stigma psychological distress | Psychological distress related to other people's reaction to their tremor. | 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. | change from baseline before thalamotomy to 12 months after thalamotomy |
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| Measure | Description | Time Frame |
|---|---|---|
| Tremor Disability Scale - Revised | self-assessed impact of tremor on skilled manual function | change from baseline before thalamotomy to 12 months after thalamotomy |
| TETRAS - Performance Scale | tremor severity measured objectively |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Padraig E O'Suilleabhain, MD | Contact | 2146482943 | padraig.osuilleabhain@utsouthwestern.edu | |
| Padraig E O'Suilleabhain | Contact | 2146482943 |
| Name | Affiliation | Role |
|---|---|---|
| Padraig E O'Suilleabhain, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Soouthwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
deidentified data will be shared on request with researchers employed by accredited third level institutions.
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| ID | Term |
|---|---|
| D014202 | Tremor |
| D057545 | Social Stigma |
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| change from baseline before thalamotomy to 12 months after thalamotomy |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |