[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04828798":3,"trial-entities:NCT04828798":97,"trial-summary:NCT04828798":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":41,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":73,"locations":76,"central_contacts":92,"overall_officials":94,"references":95,"see_also_links":96},"NCT04828798","STUDY00020724","Directional Versus Nondirectional DBS for ET","Directional Versus Nondirectional Deep Brain Stimulation of the VIM Thalamic Nucleus for Essential Tremor: Assessment of Therapeutic Window, Speech, Gait and Balance","RECRUITING","2029-10-01","2025-10","2025-10-30","2021-04-01","Oregon Health and Science University","OTHER",true,"This will be a single center (OHSU) proof of concept trial to demonstrate that directional deep brain stimulation (DBS) creates a larger therapeutic window for the treatment of essential tremor (ET), effectively treats ET, and minimizes effects on speech, gait and balance compared to nondirectional DBS.","Specific Aims:\n\n1. To compare the therapeutic window (TW) of directional versus nondirectional deep brain stimulation for treatment of tremor.\n\n   Hypothesis: directional DBS will result in a wider TW than nondirectional DBS.\n2. To compare the effects of directional versus nondirectional DBS on speech Hypothesis: Objective and subjective speech impairment will occur to a greater extent in nondirectional DBS versus directional DBS optimized for tremor control.\n3. To compare the effects of directional versus nondirectional DBS on balance and gait Hypothesis: Objective and subjective balance and gait impairment will occur to a greater extent in nondirectional DBS versus directional DBS optimized for tremor control.\n4. To assess efficacy for tremor of nondirectional and directional DBS in an optimized programming configuration Hypothesis: both directional and nondirectional DBS will significantly improve tremor compared to baseline.",[19],"Essential Tremor",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},24,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","Deep brain stimulation of the VIM Thalamic nuclei","Deep brain stimulation of the thalamus, in a directional and nondirectional manner",[34,35],"Directional deep brain stimulation","Nondirectional deep brain stimulation",[37],{"measure":38,"description":39,"timeFrame":40},"Therapeutic window","Range of therapeutic current from clinical improvement to side effect threshold, measured in milliamps, within a range of 0.0 to 5.0 milliamps","3 months",[42,45,48,51],{"measure":43,"description":44,"timeFrame":40},"Improvement of tremor","Change in The Essential Tremor Rating Scale (TETRAS) combined score. Range = 0 to112. Higher score = worse outcome.",{"measure":46,"description":47,"timeFrame":40},"Compare the effects of directional versus nondirectional DBS on self perception of speech","Self Perception of speech: Subjects will rate their \"ability to speak\" on a VAS (from 0 \\[normal\\] to 100 mm \\[worst\\]) in each condition.",{"measure":49,"description":50,"timeFrame":40},"Compare the effects of directional versus nondirectional DBS on balance and gait","The Activities-specific Balance Confidence (ABC) scale is a 16-item self-report measure in which participants rate their balance confidence on a 0-100 scale (0 = 0 no confidence, 100 = 100 complete confidence).",{"measure":52,"description":53,"timeFrame":40},"Compare the effects of directional versus nondirectional DBS on perceptual assessment of voice and speech","Perceptual assessment of voice and speech will be completed with listeners judging a reading sample using a 100mm Visual Analog Scale (VAS).","ALL","18 Years","80 Years",false,{"inclusion":59,"exclusion":61,"raw_text":72},[60],"A tremor syndrome of bilateral upper limb action tremor with at least 3 years' duration",[62,63,64,65,66,67,68,69,70,71],"Patients who have decided not to receive DBS for control of their medication-refractory essential tremor.","Patients with secondary tremor (ie not Essential Tremor), such as side effects from medications, secondary to another identified neurologic disease (eg multiple sclerosis, -----Parkinson's disease, dystonia).","Prior history of deep brain stimulation.","Prior history of thalamotomy.","A history or signs of dystonia, ataxia or parkinsonism.","Task specific tremor.","Orthostatic tremor.","Patients with cardiac pacemakers, defibrillators, or neurostimulators.","Patients who require MRI, ECT, rTMS, or diathermy.","Subjects with other type of neurological disease or injury.","Inclusion Criteria:\n\n* A tremor syndrome of bilateral upper limb action tremor with at least 3 years' duration\n\nExclusion Criteria:\n\n* Patients who have decided not to receive DBS for control of their medication-refractory essential tremor.\n* Patients with secondary tremor (ie not Essential Tremor), such as side effects from medications, secondary to another identified neurologic disease (eg multiple sclerosis, -----Parkinson's disease, dystonia).\n* Prior history of deep brain stimulation.\n* Prior history of thalamotomy.\n* A history or signs of dystonia, ataxia or parkinsonism.\n* Task specific tremor.\n* Orthostatic tremor.\n* Patients with cardiac pacemakers, defibrillators, or neurostimulators.\n* Patients who require MRI, ECT, rTMS, or diathermy.\n* Subjects with other type of neurological disease or injury.",[74,75],"ADULT","OLDER_ADULT",[77],{"facility":78,"status":8,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":89},"Oregon Health & Science University","Portland","Oregon","97239","United States",[84],{"name":85,"role":86,"phone":87,"email":88},"Zoe Fanning","CONTACT","503-494-7772","fanningz@ohsu.edu",{"lat":90,"lon":91},45.52345,-122.67621,[93],{"name":85,"role":86,"phone":87,"email":88},[],[],[],{"nct_id":4,"conditions":98,"biomarkers":99},[19],[],{"nct_id":4,"found":15,"summary":101,"prompt_version":111},{"design":102,"status":103,"heading":104,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This is an interventional study planning to enroll 24 participants. It will compare directional and nondirectional deep brain stimulation.","completed","Directional Versus Nondirectional DBS for Essential Tremor","This study is looking at a treatment for Essential Tremor (ET), a condition causing shaking. It's testing Deep Brain Stimulation (DBS) of the VIM Thalamic nuclei, comparing a newer \"directional\" method with the standard \"nondirectional\" method. Researchers want to see if directional DBS creates a wider \"therapeutic window\" (meaning it can be adjusted more easily for good results) and if it causes fewer side effects like speech, balance, or walking problems. You might be able to join if you are 18 to 80 years old, have had ET for at least three years, and your tremor affects both upper limbs. The study aims to see if directional DBS works better and has fewer side effects than nondirectional DBS. The study status is unclear, and it plans to enroll 24 participants.","The primary endpoint, therapeutic window, is measured at 3 months.",130,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]