Action TremorNCT07430761
ET Stigma Response to Tremor Suppression
An observational study of Action Tremor and Stigma, Social, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Action Tremor, Stigma, Social
- What is being tested?
- stereotactic thalamotomy with focused ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 30 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- Patient declines to participate in this observational study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Padraig E O'Suilleabhain contact
United States1 site, 1 recruiting
- Recruiting
University of Texas Soouthwestern Medical Center
Dallas, Texas, 75390
Padraig E O'Suilleabhain, MD, 214-648-8737
About this study
Official title: ET Stigma Response to Tremor Suppression With Focused Ultrasound Thalamotomy
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.
Read the detailed description
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.
- The ET-stigma distress scale which has 11 items each with 5 response options ranging from "strongly disagree" to "strongly agree"
- the ET stigma dysfunction scale which has 5 items each with 3 response options ranging from "not at all or rarely" to "frequently"
- the Tremor Disability Scale-Revised with 20 items each with 4 response options ranging from "no difficulty" to "cannot perform the task".
- Conditions
- Action Tremor, Stigma, Social
- Being tested
- stereotactic thalamotomy with focused ultrasound
- Keywords
- Essential tremor, stigma, thalamotomy, high intensity focused ultrasound
- Medical subject headings
- Tremor, Social Stigma, Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic thalamotomy with focused ultrasoundProcedure or surgery
stereotactic thalamotomy with high intensity focused ultrasound, guided by four-tract tractography
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: stereotactic thalamotomy with focused ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
ET stigma psychological distress
Psychological distress related to other people's reaction to their tremor.
Measured: 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.
Measured: change from baseline before thalamotomy to 12 months after thalamotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Jan 2025
- Primary completion30 May 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Action TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Padraig O'Suilleabhain, University of Texas Southwestern Medical Center
- Investigators
- Padraig E O'Suilleabhain, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430761
- Sponsor's protocol ID
- STU20250223
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: deidentified data will be shared on request with researchers employed by accredited third level institutions.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ET Stigma Response to Tremor Suppression With Focused Ultrasound Thalamotomy
- ClinicalTrials.gov ID
- NCT07430761
- Acronym / sponsor ID
- STU20250223
- Conditions
- Action Tremor, Stigma, Social
- Keywords
- Essential tremor, stigma, thalamotomy, high intensity focused ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- The ET-stigma distress scale which has 11 items each with 5 response options ranging from "strongly disagree" to "strongly agree"
- the ET stigma dysfunction scale which has 5 items each with 3 response options ranging from "not at all or rarely" to "frequently"
- the Tremor Disability Scale-Revised with 20 items each with 4 response options ranging from "no difficulty" to "cannot perform the task".
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ET for thalamotomy | – | Procedure: stereotactic thalamotomy with focused ultrasoundPatients with diagnosis of problematic essential tremor refractory to pharmacologic treatment who are to undergo stereotactic thalamotomy with high intensity focused ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patient declines to participate in this observational study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stereotactic thalamotomy with focused ultrasoundstereotactic thalamotomy with high intensity focused ultrasound, guided by four-tract tractography | Procedure or surgery | ET for thalamotomy |
Primary outcome
ET stigma psychological distress
Time frame: change from baseline before thalamotomy to 12 months after thalamotomy
Psychological distress related to other people's reaction to their tremor.
ET stigma social dysfunction
Time frame: change from baseline before thalamotomy to 12 months after thalamotomy
Social avoidance and maladaptive behaviors related to other people's reaction to tremor.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No. deidentified data will be shared on request with researchers employed by accredited third level institutions.
Related trials for Action Tremor
Active, not recruiting
Responsive Deep Brain Stimulator for Essential Tremor
Essential Tremor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Padraig E O'Suilleabhain contact
Padraig E O'Suilleabhain, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Action Tremor and Stigma, Social, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Padraig E O'Suilleabhain, MD (2146482943, padraig.osuilleabhain@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ET stigma psychological distress (time frame: change from baseline before thalamotomy to 12 months after thalamotomy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.