[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07207122":3,"trial-entities:NCT07207122":178,"trial-summary:NCT07207122":181},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":46,"secondary_outcomes":54,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":14,"eligibility_criteria":68,"std_ages":90,"locations":93,"central_contacts":170,"overall_officials":175,"references":176,"see_also_links":177},"NCT07207122","00085251","Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease","RECRUITING","2026-12","2026-07","2026-07-31","2025-10-08","Sanmai Technologies PBC dba Sanmai","INDUSTRY",false,"This is a pilot randomized, sham-controlled, double-blind, multi-center study evaluating the safety and preliminary effectiveness of the Gen0Bh Transcranial Focused Ultrasound System for the treatment of motor symptoms in individuals with idiopathic Parkinson's disease.","Participants will be randomized in a 1:1 allocation to receive either active or sham stimulation. Both participants and outcome assessors will remain blinded to treatment assignment. The study consists of 20 treatment sessions administered over approximately 4-6 weeks, followed by longitudinal follow-up through 3 months.",[18],"Parkinson Disease",[20,21,22,23,24,25,26],"Low-intensity focused ultrasound neuromodulation","noninvasive neuromodulation","mild cognitive impairment","Parkinson disease dementia","PD","Parkinson","Parkinson disease","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},60,"ESTIMATED",[35,41],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DEVICE","Gen0Bh Transcranial Focused Ultrasound System (Active)","The investigational Gen0Bh system delivers noninvasive, transcranial focused ultrasound to modulate neural activity in the bilateral globus pallidus. Stimulation parameters, including frequency, intensity, and duty cycle, are pre-specified and controlled by the device software. Treatments are administered by trained study personnel in a clinical setting over 20 sessions across approximately 4 to 6 weeks.",[40],"Active Transcranial Focused Ultrasound",{"type":36,"name":42,"description":43,"armGroupLabels":44},"Gen0Bh Transcranial Focused Ultrasound System (Sham)","The sham configuration uses the same device platform and mimics all procedural aspects of active treatment, including acoustic coupling, device setup, and session duration, without delivering therapeutic ultrasound energy to the target region. This approach is designed to maintain participant and assessor blinding.",[45],"Sham Transcranial Focused Ultrasound",[47,51],{"measure":48,"description":49,"timeFrame":50},"Change in MDS-UPDRS Part III Total Score (OFF Medication State)","The MDS-UPDRS Part III is a clinician-administered assessment of motor function in Parkinson's disease. It includes 18 items with 33 individual ratings, each scored from 0 (normal) to 4 (severe), with a total score range of 0 to 132. Higher scores indicate worse motor impairment.\n\nAssessments will be conducted in the OFF-medication state by trained, blinded raters using standardized procedures. The outcome measure is defined as the change from baseline in total score at post-treatment milestones (after Sessions 5, 10, 15, and 20), comparing active versus sham groups.","Baseline up to 6 weeks",{"measure":52,"description":53,"timeFrame":50},"Incidence of Serious Adverse Device Events (SADEs)","Number and proportion of participants experiencing Serious Adverse Device Events (SADEs), including severity and relationship to the investigational device, assessed from baseline through completion of 20 treatment sessions.",[55,58,62],{"measure":56,"description":57,"timeFrame":50},"Motor Function Assessments","Finger Tapping Test - Change from baseline in tapping speed and amplitude.\n\n* 10-Meter Timed Walk Test - Change from baseline in time required to walk 10 meters.\n* Archimedean Spiral Test - Change from baseline in tremor severity based on spiral drawing performance.\n* Timed Up and Go (TUG) - Change from baseline in time required to stand, walk, turn, and sit.",{"measure":59,"description":60,"timeFrame":61},"Patient- and Clinician-Reported Outcomes","PDQ-39 - Change from baseline in quality of life.\n\n* PGIC - Participant-reported overall improvement.\n* CGIC - Clinician-rated overall improvement.","Baseline through Month 3",{"measure":63,"description":64,"timeFrame":61},"Psychiatric and Non-Motor Outcomes","GAD-7 - Change from baseline in anxiety symptoms.\n\n. Beck Depression Inventory - Change from baseline in depressive symptoms.","ALL","22 Years","80 Years",{"inclusion":69,"exclusion":77,"raw_text":89},[70,71,72,73,74,75,76],"Adults aged 22 to 80 years.","Diagnosis of idiopathic Parkinson's disease.","MDS-UPDRS Part III score ≥25 in OFF-medication state at baseline.","Stable dopaminergic therapy for at least 30 days prior to enrollment.","English proficiency.","Normal or corrective hearing and vision.","Ability to provide informed consent (or availability of an LAR) and comply with protocol requirements.",[78,79,80,81,82,83,84,85,86,87,88],"Atypical or secondary Parkinsonism.","Prior deep brain stimulation or intracranial surgery.","MoCA score \\\u003C23.","Severe psychiatric illness (e.g., psychosis, suicidality, untreated major depression).","History of seizure or intracranial pathology.","Significant neurologic disease (e.g. brain tumor, multiple sclerosis)","Contraindication to MRI or ultrasound.","Unstable systemic medical conditions.","Active malignancy or history of cancer within the past 5 years.","Pregnancy or breastfeeding.","Participation in another interventional trial.","Inclusion Criteria:\n\n* Adults aged 22 to 80 years.\n* Diagnosis of idiopathic Parkinson's disease.\n* MDS-UPDRS Part III score ≥25 in OFF-medication state at baseline.\n* Stable dopaminergic therapy for at least 30 days prior to enrollment.\n* English proficiency.\n* Normal or corrective hearing and vision.\n* Ability to provide informed consent (or availability of an LAR) and comply with protocol requirements.\n\nExclusion Criteria:\n\n* Atypical or secondary Parkinsonism.\n* Prior deep brain stimulation or intracranial surgery.\n* MoCA score \\\u003C23.\n* Severe psychiatric illness (e.g., psychosis, suicidality, untreated major depression).\n* History of seizure or intracranial pathology.\n* Significant neurologic disease (e.g. brain tumor, multiple sclerosis)\n* Contraindication to MRI or ultrasound.\n* Unstable systemic medical conditions.\n* Active malignancy or history of cancer within the past 5 years.\n* Pregnancy or breastfeeding.\n* Participation in another interventional trial.",[91,92],"ADULT","OLDER_ADULT",[94,115,135,154],{"facility":95,"status":7,"city":96,"state":97,"zip":98,"country":99,"contacts":100,"geoPoint":112},"University of Arizona","Tucson","Arizona","85719","United States",[101,106,109],{"name":102,"role":103,"phone":104,"email":105},"Erica Lord","CONTACT","(520) 866-1033","ericacook@arizona.edu",{"name":107,"role":103,"phone":104,"email":108},"Alexa Rukstela","alexarukstela@arizona.edu",{"name":110,"role":111},"John Allen, Ph.D.","PRINCIPAL_INVESTIGATOR",{"lat":113,"lon":114},32.22174,-110.92648,{"facility":116,"status":7,"city":117,"state":118,"zip":119,"country":99,"contacts":120,"geoPoint":132},"The Regenesis Project","Santa Monica","California","90403",[121,126,130],{"name":122,"role":103,"phone":123,"phoneExt":124,"email":125},"Sheena Tan","310-829-5968","214","stan@theneuroassociates.com",{"name":127,"role":103,"phone":128,"phoneExt":124,"email":129},"Kevin Enemuo","(310) 829-5968","kenemuo@theneuroassociates.com",{"name":131,"role":111},"Sheldon E Jordan, MD, FAAN",{"lat":133,"lon":134},34.01949,-118.49138,{"facility":136,"status":7,"city":137,"state":138,"zip":139,"country":99,"contacts":140,"geoPoint":151},"UF - McKnight Brain Institute","Gainesville","Florida","32610",[141,145,149],{"name":142,"role":103,"phone":143,"email":144},"Damon Carpenter","352-294-5837","carpenter.nb@phhp.ufl.edu",{"name":146,"role":103,"phone":147,"email":148},"Andrew O'Shea","(352) 294-8631","aoshea@phhp.ufl.edu",{"name":150,"role":111},"Joseph Gullett, Ph.D.",{"lat":152,"lon":153},29.65163,-82.32483,{"facility":155,"status":7,"city":156,"state":156,"zip":157,"country":99,"contacts":158,"geoPoint":167},"Radial Midtown Manhattan","New York","10018",[159,163,165],{"name":160,"role":103,"phone":161,"email":162},"Angelique Lucien","(516) 908-8540","ask@meetradial.com",{"name":164,"role":103,"phone":161,"email":162},"Ahmed Tahseen, M.D",{"name":166,"role":111},"Owen Muir, M.D",{"lat":168,"lon":169},40.71427,-74.00597,[171],{"name":172,"role":103,"phone":173,"email":174},"Clinical Team","408-455-3817","clinical@sanm.ai",[],[],[],{"nct_id":4,"conditions":179,"biomarkers":180},[18],[],{"nct_id":4,"found":182,"summary":183,"prompt_version":193},true,{"design":184,"status":185,"heading":186,"summary":187,"follow_up":188,"word_count":189,"commitments":190,"compensation":191,"drugs_mentioned":192},"This is a pilot, randomized, sham-controlled, double-blind study involving 60 participants. Participants will be randomly assigned to receive either the active Gen0Bh system or a sham (inactive) version, and neither you nor the study staff will know which you are receiving.","completed","Transcranial Focused Ultrasound for Parkinson's Disease","This study is testing a device called the Gen0Bh Transcranial Focused Ultrasound System to see if it can help improve movement problems in people with Parkinson's disease. This system uses sound waves to gently stimulate specific areas of the brain. You might be able to join if you are between 22 and 80 years old, have been diagnosed with idiopathic Parkinson's disease (Parkinson's disease with no known cause), and have stable medication. The researchers will measure success by looking at changes in your movement symptoms using a special rating scale (MDS-UPDRS Part III Total Score) and by tracking any serious device-related problems. The current status of this study is unclear, but it plans to enroll 60 participants.","You will be followed for up to 3 months after the treatment sessions.",117,"You would receive 20 treatment sessions over about 4-6 weeks. Your movement symptoms will be measured at the beginning of the study and up to 6 weeks later.","Not stated in the trial record.",[],"v2"]