[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568603":3},{"organization":4,"outcomesModule":7,"designInfo":77,"detailedDescription":76,"studyPopulation":76,"armGroups":88,"interventions":97,"overallOfficials":103,"centralContacts":107,"locations":116,"responsibleParty":133,"collaborators":137,"id":141,"slug":76,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":142,"sex":148,"minAge":149,"maxAge":150,"enrollmentInfo":151,"targetDuration":76,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":118,"whyStopped":76,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"University of Kentucky","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":76},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Successful deployment of bilateral peripheral nerve tissue (PNT) into the brain","Number of participants in each study arm who successfully receive bilateral PNT delivery.","Intraoperative",{"measure":14,"description":15,"timeFrame":16},"Number of participants completing 12 month study visit","Total number of participants to complete study visit by arm assignment","12-month study visit",{"measure":18,"description":19,"timeFrame":20},"Study-related adverse events as assessed by MedDRA v27","Total number of study-related adverse events experienced by participants.","Enrollment to 24-month study visit",{"measure":22,"description":23,"timeFrame":20},"Study-related serious adverse events as assessed by MedDRA v.27","Total number of serious adverse events experienced by participants",[25,29,33,37,40,44,48,52,55,59,62,65,69,73],{"measure":26,"description":27,"timeFrame":28},"PNT deployment attempts","Number of deployment attempts required, per participant, to deliver bilateral PNT by group allocation","During surgery",{"measure":30,"description":31,"timeFrame":32},"Mean change in Montreal Cognitive Assessment (MoCA) scores","Mean change in MoCA scores for participants at study visits compared to baseline by group allocation. Assessment is scored from 0-30 with a score of 26 or better indicating normal cognition. A score less than 26 indicates a cognitive deficit.","Baseline 6, 12 and 24 months after surgery",{"measure":34,"description":35,"timeFrame":36},"Mean change in Neuropsychological assessment scores","Participants complete a neuropsychological assessment battery that meets the Movement Disorder Society (MDS) guidelines for determining mild cognitive impairment\u002Fmild neurocognitive disorder. Domains include attention and working memory, executive functioning, memory (verbal and visual), language, and visuospatial skills. Participants' raw scores will be converted to standardized scores based on appropriate norms (e.g., age-based norms). Participants' 12 and 24-month re-evaluation will be compared to their baseline pre-surgical assessment to determine change from baseline on each measure. A change that exceeds 1.5 standard deviation from their baseline performance will be considered notable.","Baseline, 12 and 24 months",{"measure":38,"description":39,"timeFrame":36},"Change in Neuropsychological diagnosis","Changes in participant neuropsychological diagnoses during scheduled evaluations will be reported. e.g. No cognitive diagnosis progressing to mild neurocognitive disorder.",{"measure":41,"description":42,"timeFrame":43},"Change in Neuropsychological domains with impairment","A count of the number of domains with impairment at each study visit to compare with previous study visits.","At 12, 24 months compared to baseline",{"measure":45,"description":46,"timeFrame":47},"Mean change in Modified Schwab and England Scale of Activities of Daily Living scores","Mean change participant independence levels as measured in Schwab and England Scale of Activities of Daily Living scores. 100% = completed independent and 0% being completely dependent.","At 6, 12, 24 months compared to baseline",{"measure":49,"description":50,"timeFrame":51},"Mean change in Parkinson's Disease Questionnaire-8 (PDQ-8) quality of life scores","Assess changes in participant's quality of life. Questionnaire is scored from 0-32 with higher scores indicating poorer quality of life.","At 12 and 24 months compared to baseline",{"measure":53,"description":54,"timeFrame":51},"Mean change in Non-motor symptom scale scores","Assessment used to identify Parkinson's disease related non-motor symptoms experienced by participants. The scale measures the frequency and severity of symptoms and is scored from 0-360 with higher scores indicating more frequent and severe symptoms.",{"measure":56,"description":57,"timeFrame":58},"Mean change of the Movement Disorder Society - Unified Parkinsons Disease Rating Scale (MDS-UPDRS) Part I scores","MDS-UPDRS Part I scores non-motor symptoms effecting activities of daily living in those with Parkinson's Disease. Scores range from 0-52 with higher scores indicating greater symptom severity.","6, 12, and 24 months as compared to baseline",{"measure":60,"description":61,"timeFrame":47},"Mean change of the MDS-UPDRS Part II scores","MDS-UPDRS Part II scores motor symptoms effecting activities of daily living in those with Parkinson's Disease. Scores range from 0-52 with higher scores indicating greater symptom severity.",{"measure":63,"description":64,"timeFrame":47},"Mean change in MDS-UPDRS Part III scores","MDS-UPDRS Part III scores motor symptoms associated with Parkinson's Disease. Part III scores range from 0-132 with higher scores indicating higher symptom severity.",{"measure":66,"description":67,"timeFrame":68},"Mean change in MDS-UPDRS Part IV scores","MDS-UPDRS Part IV scores motor complications such as fluctuations and dyskinesia's associated with anti-Parkinson's medications. Scores range from 0-24 with higher scores indicating greater severity in motor complications.","At 6, 12, and 24 months compared to baseline",{"measure":70,"description":71,"timeFrame":72},"Number of participants completing 24-month study visit","Total number of participants completing 24 month study visit by group allocation","24-month study visit",{"measure":74,"description":75,"timeFrame":32},"Mean change in Dementia Rating Scale (DSRS)","A survey to assess and rate changes the cognitive and behavioral functioning of participants. Scale is scored from 0-54 with being higher numbers indicating greater dementia severity.",null,{"allocation":78,"interventionModel":79,"interventionModelDescription":76,"primaryPurpose":80,"observationalModel":76,"timePerspective":76,"maskingInfo":81},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":82,"maskingDescription":76,"whoMasked":83},"QUADRUPLE",[84,85,86,87],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[89,94],{"label":90,"type":91,"description":76,"interventionNames":92},"Peripheral nerve tissue (PNT) deployment to the Substantia Nigra","ACTIVE_COMPARATOR",[93],"Procedure: Reparative Autologous peripheral nerve tissue",{"label":95,"type":91,"description":76,"interventionNames":96},"Peripheral nerve tissue (PNT) deployment to the nucleus basalis of Meynert",[93],[98],{"type":99,"name":100,"description":101,"armGroupLabels":102,"otherNames":76},"PROCEDURE","Reparative Autologous peripheral nerve tissue","At the time participants are receiving the standard of care deep brain stimulation (DBS) surgery, a standard incision on the lateral aspect near the ankle is made, the sural nerve is identified, an about 3 cm biopsy of the sural nerve is obtained and the incision is closed.\n\nFrom the biopsied section, the epineurium is removed, fascicles are cut, and (\\~5 pieces per side; \\~ 5mm length x 1.5 mm diameter: approximately 10 cubic millimeters) implanted bilaterally into the nucleus basalis of Meynert (NBM) or substantia nigra (SN).",[90,95],[104],{"name":105,"affiliation":5,"role":106},"Craig G van Horne, MD, PhD","PRINCIPAL_INVESTIGATOR",[108,113],{"name":109,"role":110,"phone":111,"phoneExt":76,"email":112},"Jaimie Hixson","CONTACT","8593231908","jaimie.henderson@uky.edu",{"name":114,"role":110,"phone":76,"phoneExt":76,"email":115},"Group Monitored Email","nervegraft@uky.edu",[117],{"facility":5,"status":118,"city":119,"state":120,"zip":121,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":129,"contacts":130},"RECRUITING","Lexington","Kentucky","40536","United States","US",{"type":125,"coordinates":126},"Point",[127,128],-84.47772,37.98869,{"lat":128,"lon":127},[131],{"name":109,"role":110,"phone":132,"phoneExt":76,"email":112},"859-323-1908",{"type":134,"investigatorFullName":135,"investigatorTitle":136,"investigatorAffiliation":5,"oldNameTitle":76,"oldOrganization":76},"SPONSOR_INVESTIGATOR","Craig van Horne, MD, PhD","Department of Neurosurgery Chair",[138],{"name":139,"class":140},"National Institute on Aging (NIA)","NIH","100568603",false,"NCT06683378","A Study to Evaluate Feasibility, Safety, and Clinical Responses of Implanting Autologous Peripheral Nerve Tissue Into the Brain for Non-motor or Motor Symptoms in Patients With Parkinson's Disease Undergoing DBS Surgery","Phase I Randomized, Double-blind Study to Evaluate Feasibility, Safety, and Clinical Responses of Implanting Autologous Peripheral Nerve Tissue Into the Nucleus Basalis of Meynert or Substantia Nigra for Non-motor or Motor Symptoms in Patients With Parkinson's Disease Undergoing DBS Surgery","STAR","Inclusion Criteria:\n\n* Undergoing DBS\n* Diagnosis of clinically established or clinically probably PD as defined by MDS criteria\n* Age 45-75, inclusive\n* Able to tolerate the surgical procedure\n* Able to undergo all planned assessments\n* Available access to the sural nerve\n\nExclusion Criteria:\n\n* Any condition that would not make the subject a candidate for DBS\n* Dementia diagnosis\n* Previous PD surgery or intracranial surgery\n* Unable to undergo an MRI\n* An obstructed trajectory path to the substantia nigra and nucleus basalis of Meynert","ALL","45 Years","75 Years",{"count":152,"type":153},24,"ESTIMATED","INTERVENTIONAL",[156],"PHASE1","The investigators propose a Phase I single surgical-center, double-blinded randomized parallel clinical trial involving bilateral autologous peripheral nerve tissue (PNT) delivery into the NBM or the alternate target also affecting cognition in this population, the substantia nigra (SN), to address \"repair cell\" support of these areas. Twenty-four participants with idiopathic Parkinson's Disease (PD) who have selected, qualified and agreed to receive as standard of care deep brain stimulation (DBS) will be enrolled and randomly allocated to receive bilateral PNT deployment to either the NBM or SN at the time of DBS surgery. Participants will be allocated equally among both assignments over the course of three years (8 Year 1, 10 Year 2, 6 Year 3). Participants will be evaluated for neurocognitive, motoric function, activities of daily living, and quality of life at enrollment before surgery, two-weeks after surgery, and 6, 12, and 24 months after surgery.",[159],"Parkinson's Disease",[159,161,162,163],"Deep Brain Stimulation","DBS","Cell and Tissue Based Therapy","2025-08-11",{"date":166,"type":167},"2025-08-14","ACTUAL",{"date":169,"type":167},"2025-07-21",{"date":171,"type":153},"2028-02-28",{"name":135,"class":6},1]