[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07218952":3,"trial-entities:NCT07218952":94,"trial-summary:NCT07218952":98},{"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":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":41,"secondary_outcomes":46,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":74,"locations":77,"central_contacts":87,"overall_officials":88,"references":92,"see_also_links":93},"NCT07218952","24-006978","Radiation Therapy (RT) for Parkinson's Disease (PD)","Ultra-low Dose, DaT-SPECT-guided Radiation Therapy for the Treatment of Parkinson's Disease","ENROLLING_BY_INVITATION","2027-10","2026-06","2026-06-16","2026-01-20","Mayo Clinic","OTHER",false,"The purpose of this study is to investigate the use of ultra-low, anti-inflammatory doses of radiation therapy (RT) for the treatment of Parkinson's Disease (PD). In this study, the TrueBeam LINAC utilizes a linear accelerator (LINAC) for the delivery of radiation therapy. Dynamic conformal arc (DCA) therapy will be used to deliver a total of five (5) once-a-day radiation treatments (RT) using DaT-SPECT (Dopamine Transporter-Single-Photon Emission Computed Tomography) and MRI imaging to guide radiation treatment planning.",null,[19],"Parkinson's Disease",[21,22,23,24],"anti-inflammatory","neurodegenerative disease","radiation","low-dose","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},20,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"RADIATION","Radiation therapy","Dynamic conformal arc (DCA) therapy will be used to deliver a total of five (5) 60cGy once-a-day radiation treatments (RT) using DaT-SPECT (Dopamine Transporter-Single-Photon Emission Computed Tomography) and MRI imaging to guide radiation treatment planning.",[38],"Radiation Therapy",[40],"LINAC TrueBeam Radiation Therapy System",[42],{"measure":43,"description":44,"timeFrame":45},"Change in progression of Parkinson's Disease","Slowing of progression will be defined as a 7-point decrease in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Motor Examination (physician-assessed motor symptoms) score. The score for this scale ranges from 0 to 132, with higher numbers indicating worse disease.","Baseline, 6 months",[47,51],{"measure":48,"description":49,"timeFrame":50},"Change in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) score","The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III is a physician assessed motor examination that scores symptoms on a 0-4 scale, where 0 is normal and 4 is marked severity. The total Part III score is the sum of individual item scores. Higher scores indicate a greater severity of motor deficits.","Baseline, 3 months, 6 months",{"measure":52,"description":53,"timeFrame":50},"Change in Parkinson's Disease Questionnaire (PDQ-39) Score","The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item questionnaire that assesses the impact of Parkinson's disease on quality of life. Each item is rated on a 5-point scale: 0: never, 1: occasionally, 2: sometimes, 3: often, and 4: always. The total score ranges from 0 (no impact) to 392 (severe impact).","ALL","45 Years","70 Years",{"inclusion":58,"exclusion":69,"raw_text":73},[59,60,61,62,63,64,65,66,67,68],"Age ≥ 45 and ≤ 70 years","Diagnosis of Parkinson's disease by a Movement Disorder Neurologist","Confirmation of unilateral Parkinson's disease by Dopamine Transporter (DaT) scan","A score of 2 or less on the modified Hoehn and Yahr scale","ECOG Performance Status (PS) ≤ 2 (Appendix I).","No known genetic causes or predisposition to Parkinson's disease or related diseases.","Ability to complete questionnaires, neurological exam, and follow-up imaging independently or with assistance","Ability to provide written informed consent","Willing to provide mandatory blood samples for correlative research purposes","Willing to return to enrolling institution for follow-up",[70,71,72],"Concomitant dementia diagnosis or concerns of other memory disorder","Parkinson's Disease medication changes within the last 3 months","Receipt of radiation therapy for Parkinson's Disease outside Mayo Clinic, Rochester","Inclusion Criteria\n\n* Age ≥ 45 and ≤ 70 years\n* Diagnosis of Parkinson's disease by a Movement Disorder Neurologist\n* Confirmation of unilateral Parkinson's disease by Dopamine Transporter (DaT) scan\n* A score of 2 or less on the modified Hoehn and Yahr scale\n* ECOG Performance Status (PS) ≤ 2 (Appendix I).\n* No known genetic causes or predisposition to Parkinson's disease or related diseases.\n* Ability to complete questionnaires, neurological exam, and follow-up imaging independently or with assistance\n* Ability to provide written informed consent\n* Willing to provide mandatory blood samples for correlative research purposes\n* Willing to return to enrolling institution for follow-up\n\nExclusion Criteria\n\n* Concomitant dementia diagnosis or concerns of other memory disorder\n* Parkinson's Disease medication changes within the last 3 months\n* Receipt of radiation therapy for Parkinson's Disease outside Mayo Clinic, Rochester",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"city":80,"state":81,"zip":82,"country":83,"geoPoint":84},"Mayo Clinic in Rochester","Rochester","Minnesota","55905","United States",{"lat":85,"lon":86},44.02163,-92.4699,[],[89],{"name":90,"affiliation":13,"role":91},"Yasamin Sharifzadeh-Moghaddam","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":95,"biomarkers":97},[96],"Parkinson Disease",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]