[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03635645":3,"trial-entities:NCT03635645":84,"trial-summary:NCT03635645":87},{"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":20,"primary_purpose":13,"phases":21,"enrollment_info":23,"interventions":26,"primary_outcomes":37,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":59,"locations":62,"central_contacts":77,"overall_officials":79,"references":82,"see_also_links":83},"NCT03635645","HUM00122699","Experimental and Clinical Studies of Retinal Stimulation","RECRUITING","2023-10-30","2022-12","2022-12-14","2017-10-30","University of Michigan","OTHER",null,"The study will evaluate new methods of retinal stimulation and training with the goal of improving the visual ability of retinal prosthesis participants.","The study will test new ways to make the retinal prosthesis visual perception easier with auditory-visual training and how to make the retinal prosthesis work better at perceiving shapes.",[18],"Retinitis Pigmentosa",[],"INTERVENTIONAL",[22],"NA",{"count":24,"type":25},20,"ESTIMATED",[27,33],{"type":28,"name":29,"description":30,"armGroupLabels":31},"DEVICE","New visual processing unit (VPU) with asymmetric waveforms","A VPU will apply asymmetric and symmetric stimulation pulses.",[32],"Retinal stimulation",{"type":28,"name":34,"description":35,"armGroupLabels":36},"New VPU with bipolar stimulation","A VPU will apply bipolar stimulus pulses.",[32],[38,42],{"measure":39,"description":40,"timeFrame":41},"Percent change in stimulus thresholds","Compare baseline threshold with threshold of modified stimulus parameters. Threshold is measured in microCoulumbs ( the product of stimulus duration and stimulus amplitude).","Baseline, 8 hours",{"measure":43,"description":44,"timeFrame":41},"Change in shape perception","As measured by elongation ratio. The elongation ratio is the ratio of major axis length to minor axis length of an ellipse. Subjects will draw shapes on a touch screen and these shapes will be fit to an ellipse.",[],"ALL","25 Years","89 Years",false,{"inclusion":51,"exclusion":55,"raw_text":58},[52,53,54],"Must be implanted with an Argus II Retinal Prosthesis system.","Have 5 or more electrodes that create a perception with stimulation.","Must be willing and able to comply with the protocol testing requirements.",[56,57],"Subjects participating in another investigatory drug or device study","Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols.","Inclusion Criteria:\n\n* Must be implanted with an Argus II Retinal Prosthesis system.\n* Have 5 or more electrodes that create a perception with stimulation.\n* Must be willing and able to comply with the protocol testing requirements.\n\nExclusion Criteria:\n\n* Subjects participating in another investigatory drug or device study\n* Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols.",[60,61],"ADULT","OLDER_ADULT",[63],{"facility":12,"status":7,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":74},"Ann Arbor","Michigan","48105","United States",[69],{"name":70,"role":71,"phone":72,"email":73},"James Weiland","CONTACT","661-713-4603","weiland@umich.edu",{"lat":75,"lon":76},42.27756,-83.74088,[78],{"name":70,"role":71,"phone":72,"email":73},[80],{"name":70,"affiliation":12,"role":81},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":85,"biomarkers":86},[18],[],{"nct_id":4,"found":88,"summary":89,"prompt_version":99},true,{"design":90,"status":91,"heading":92,"summary":93,"follow_up":94,"word_count":95,"commitments":96,"compensation":97,"drugs_mentioned":98},"This interventional study plans to enroll 20 participants. It is not specified if it is randomized, blinded, or what phase it is.","completed","Retinal Stimulation for Argus II Retinal Prosthesis Users","This study is for people with Retinitis Pigmentosa who have an Argus II Retinal Prosthesis system. It's testing new ways to stimulate the retina using two different visual processing units (VPUs): one with asymmetric waveforms and another with bipolar stimulation. The goal is to improve your visual ability and make it easier to perceive shapes. To join, you must be between 25 and 89 years old, have at least 5 electrodes that create a perception with stimulation, and be able to follow the study's requirements. We'll know if the study is successful by looking at changes in how well you perceive shapes and your stimulus thresholds (how much stimulation is needed to see something). The current recruitment status is unclear.","Participants are followed for 8 hours after baseline measurements.",120,"The study measures changes in stimulus thresholds and shape perception at baseline and 8 hours later. It also involves auditory-visual training.","Not stated in the trial record.",[],"v2"]