ET Stigma Response to Tremor Suppression

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • stereotactic thalamotomy with focused ultrasound

    Procedure/Surgery

    stereotactic thalamotomy with high intensity focused ultrasound, guided by four-tract tractography

Treatment groups

220 Participants
are divided into 1 treatment group
Group A: ET for thalamotomy1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

Other outcomes

1

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
2

TETRAS - Performance Scale

tremor severity measured objectively

Time frame
change from baseline before thalamotomy to 12 months after thalamotomy

Sponsors and contacts

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