[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610284":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":49,"collaborators":52,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":20,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":20,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":32,"whyStopped":20,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Case Western Reserve University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intracortical microstimulation and peripheral nerve stimulation for people with tetraplegia","EXPERIMENTAL","The purpose of the proposed study is to investigate the perception and functional impact of sensory neurostimulation in participants with tetraplegia. Investigators will develop and implement novel paradigms of intracortical microstimulation (ICMS) applied to primary somatosensory cortex (S1) and peripheral nerve stimulation (PNS) applied to upper extremity nerves through chronically-implanted cuff electrodes. Investigators will also develop and assess hybrid neurostimulation paradigms involving paired application of ICMS and PNS. For each paradigm, investigators will quantify the perceived sensation with classic psychophysical methods. Investigators will also implement the approach into closed-loop tasks in virtual reality controlled through decoded cortical signals recorded from intracortical microelectrode arrays. Finally, investigators will assess the impact of each stimulation paradigm on residual sensory function.",[13],"Device: Brain Computer Interface (BCI) - Functional Electrical Stimulation (FES) system",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Brain Computer Interface (BCI) - Functional Electrical Stimulation (FES) system","Participants with tetraplegia who have received intracortical arrays in the sensory cortex and peripheral nerve cuff electrodes will undergo a variety of stimulation paradigms to investigate the perception and functional impact of sensory neurostimulation.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Emily Graczyk, Ph.D.","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","216.368.5182","elg46@case.edu",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Cleveland","Ohio","44106","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-81.69541,41.4995,{"lat":42,"lon":41},[45,48],{"name":23,"role":27,"phone":46,"phoneExt":20,"email":47},"216-368-5182","emily.graczyk@case.edu",{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":24,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Emily Graczyk","Assistant Professor, Biomedical Engineering",[53,55,58],{"name":54,"class":6},"University Hospitals Cleveland Medical Center",{"name":56,"class":57},"Cleveland Clinic Lerner Research Institute","UNKNOWN",{"name":59,"class":60},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100610284","development-of-optimal-sensory-feedback-strategies-to-maximize-function-after-tetraplegia-100610284",false,"NCT07225582","Development of Optimal Sensory Feedback Strategies to Maximize Function After Tetraplegia","Development of Optimal Sensory Feedback Strategies to Maximize Function After Tetraplegia: A Sub-study of the Reconnecting the Hand and Arm to the Brain (ReHAB) Clinical Trial","Inclusion Criteria:\n\n1. Enrolled in the ReHAB clinical trial and received ReHAB system components via implantation surgery.\n2. Willingness and availability to follow the study protocol.\n\nExclusion Criteria:\n\n1. Lack of function or operability of all implanted ReHAB system components\n2. Severe pain or other chronic medical condition that would prevent the participant from completing study-related activities","ALL","22 Years","65 Years",{"count":72,"type":73},3,"ESTIMATED","INTERVENTIONAL",[76],"NA","The goal of this clinical trial is to learn more about how stimulating the nerves involved in sensation (either in the limbs or in the brain) can be used to restore sensation in participants who have a spinal cord injury. Participants in this study will have already been enrolled in the \"Reconnecting the Hand and Arm to the Brain (ReHAB)\" study, and received small electrodes in a part of the brain that is involved in sensing touch and pressure in the hand. The ReHAB study participants will also have received electrodes around the nerves in their arm. In this clinical trial, participants will receive two types of electrical stimulation:\n\n* Intracortical microstimulation (ICMS) which involves sending small electrical pulses to the part of the brain that processes sensation.\n* Peripheral nerve stimulation (PNS) which involves sending small electrical pulses to the nerves in the arm that transmit sensations from the hand.\n\nResearchers will try different patterns of stimulation for both ICMS and PNS and study how the participants perceive the sensations from the different stimulation patterns. The researchers will also study how combining ICMS and PNS affects the perceived sensations.",[79,80],"Spinal Cord Injury Cervical","Spinal Cord Injuries (Complete and Incomplete)",[82,83,84,85],"spinal cord injury","tetraplegia","intracortical microstimulation","peripheral nerve stimulation","2026-02-17",{"date":88,"type":89},"2026-02-19","ACTUAL",{"date":91,"type":89},"2026-01-13",{"date":93,"type":73},"2030-09-01",{"name":5,"class":6},1]