Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 8:54 PM
Study NCT ID:
NCT07430761
Status:
RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ET Stigma Response to Tremor Suppression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014202', 'term': 'Tremor'}, {'id': 'D057545', 'term': 'Social Stigma'}, {'id': 'D020329', 'term': 'Essential Tremor'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-02-17', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tremor Disability Scale - Revised', 'timeFrame': 'change from baseline before thalamotomy to 12 months after thalamotomy', 'description': 'self-assessed impact of tremor on skilled manual function'}, {'measure': 'TETRAS - Performance Scale', 'timeFrame': 'change from baseline before thalamotomy to 12 months after thalamotomy', 'description': 'tremor severity measured objectively'}], 'primaryOutcomes': [{'measure': 'ET stigma psychological distress', 'timeFrame': 'change from baseline before thalamotomy to 12 months after thalamotomy', 'description': "Psychological distress related to other people's reaction to their tremor."}, {'measure': 'ET stigma social dysfunction', 'timeFrame': 'change from baseline before thalamotomy to 12 months after thalamotomy', 'description': "Social avoidance and maladaptive behaviors related to other people's reaction to tremor."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Essential tremor', 'stigma', 'thalamotomy', 'high intensity focused ultrasound'], 'conditions': ['Action Tremor', 'Stigma, Social']}, 'descriptionModule': {'briefSummary': '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.\n\nFor 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.', 'detailedDescription': 'Study procedures:\n\nSubjects 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.\n\n1. The ET-stigma distress scale which has 11 items each with 5 response options ranging from "strongly disagree" to "strongly agree"\n2. the ET stigma dysfunction scale which has 5 items each with 3 response options ranging from "not at all or rarely" to "frequently"\n3. the Tremor Disability Scale-Revised with 20 items each with 4 response options ranging from "no difficulty" to "cannot perform the task".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People with ET as diagnosed by a movement disorder neurologist\n* Tremor of sufficient severity and impact on quality of life so as to justify a lesional brain procedure\n* Competent to consent to undergoing high intensity focused ultrasound thalamotomy targeted by 4-tract tractography\n* Provide verbal informed consent to this study of ET stigma\n\nExclusion Criteria:\n\n* Patient declines to participate in this observational study'}, 'identificationModule': {'nctId': 'NCT07430761', 'briefTitle': 'ET Stigma Response to Tremor Suppression', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'ET Stigma Response to Tremor Suppression With Focused Ultrasound Thalamotomy', 'orgStudyIdInfo': {'id': 'STU20250223'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ET for thalamotomy', 'description': 'Patients with diagnosis of problematic essential tremor refractory to pharmacologic treatment who are to undergo stereotactic thalamotomy with high intensity focused ultrasound.', 'interventionNames': ['Procedure: stereotactic thalamotomy with focused ultrasound']}], 'interventions': [{'name': 'stereotactic thalamotomy with focused ultrasound', 'type': 'PROCEDURE', 'description': 'stereotactic thalamotomy with high intensity focused ultrasound, guided by four-tract tractography', 'armGroupLabels': ['ET for thalamotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': "Padraig E O'Suilleabhain, MD", 'role': 'CONTACT', 'phone': '214-648-8737'}], 'facility': 'University of Texas Soouthwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': "Padraig E O'Suilleabhain, MD", 'role': 'CONTACT', 'email': 'padraig.osuilleabhain@utsouthwestern.edu', 'phone': '2146482943'}, {'name': "Padraig E O'Suilleabhain", 'role': 'CONTACT', 'phone': '2146482943'}], 'overallOfficials': [{'name': "Padraig E O'Suilleabhain, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'deidentified data will be shared on request with researchers employed by accredited third level institutions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': "Padraig O'Suilleabhain", 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}