[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06710626":3,"trial-entities:NCT06710626":98,"trial-summary:NCT06710626":103},{"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":24,"study_type":37,"primary_purpose":38,"phases":39,"enrollment_info":41,"interventions":44,"primary_outcomes":53,"secondary_outcomes":57,"sex":66,"minimum_age":17,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":67,"std_ages":77,"locations":81,"central_contacts":91,"overall_officials":92,"references":93,"see_also_links":94},"NCT06710626","N1-EFS-100","Control of Assistive Devices Via Brain-Computer Interface Technology","CONVOY: An Early Feasibility Study of Neural Control of Assistive Devices Via Brain-Computer Interface Technology","ENROLLING_BY_INVITATION","2031-05-25","2025-06","2025-06-05","2024-11-25","Neuralink Corp","INDUSTRY",false,"The CONVOY Study is a clinical trial designed to explore the feasibility of participants from the PRIME Study (NCT06429735) using the N1 Implant to control various assistive devices. The main goal is to determine whether participants can successfully modulate their brain activity to control devices, such as an Assistive Robotic Arm (ARA). This study will assess the effectiveness, consistency, and safety of neural control using the ARA and other assistive devices.",null,[19,20,21,22,23],"Tetraplegia\u002FTetraparesis","Amyotrophic Lateral Sclerosis (ALS)","Quadriplegia","Spinal Cord Injury (SCI)","Spinal Cord Injury Cervical",[25,26,27,28,29,30,31,32,21,33,34,35,36],"brain computer interface","robotic arm","assistive device","Neuralink N1 Implant","Neuralink","N1 Implant","ALS","Spinal cord injury","tetraplegia","Robot","external device control","neuroprosthetics","INTERVENTIONAL","OTHER",[40],"NA",{"count":42,"type":43},3,"ESTIMATED",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":51},"DEVICE","Assistive Robotic Arm","The intervention involves using the N1 Implant, a wireless brain-computer interface (BCI), to enable participants to control the Assistive Robotic Arm through neural signals.",[50],"Single",[52],"BCI controlled robotic arm",[54],{"measure":55,"timeFrame":56},"Ability of participants to modulate brain activity for controlling an assistive device via the N1 Implant.","3-months following first use of the assistive device",[58,61,64],{"measure":59,"timeFrame":60},"Rate of Device-Related Adverse Events (AE)","Up to 72 months after enrollment",{"measure":62,"timeFrame":63},"Assessment of Quality of Life Using the Psychosocial Impact of Assistive Devices Scale (PIADS)","From enrollment, every 3 months, up to 72 months",{"measure":65,"timeFrame":63},"Change in Assistive Technology Device Predisposition Assessment (ATD PA) Score","ALL",{"inclusion":68,"exclusion":71,"raw_text":76},[69,70],"Continued enrollment in the PRIME Study.","Implanted with the N1 Implant.",[72,73,74,75],"Explantation or deactivation of the N1 Implant.","Insufficient N1 Implant BCI performance demonstrated.","Lack of a suitable physical space to perform research sessions.","Any condition which, in the opinion of the Investigator, would compromise the candidate's ability to safely participate in the study.","Inclusion Criteria:\n\n* Continued enrollment in the PRIME Study.\n* Implanted with the N1 Implant.\n\nExclusion Criteria:\n\n* Explantation or deactivation of the N1 Implant.\n* Insufficient N1 Implant BCI performance demonstrated.\n* Lack of a suitable physical space to perform research sessions.\n* Any condition which, in the opinion of the Investigator, would compromise the candidate's ability to safely participate in the study.",[78,79,80],"CHILD","ADULT","OLDER_ADULT",[82],{"facility":83,"city":84,"state":85,"zip":86,"country":87,"geoPoint":88},"Barrow Neurological Institute","Phoenix","Arizona","85013","United States",{"lat":89,"lon":90},33.44838,-112.07404,[],[],[],[95],{"label":96,"url":97},"Neuralink Website","https:\u002F\u002Fneuralink.com\u002F",{"nct_id":4,"conditions":99,"biomarkers":102},[100,21,101],"Amyotrophic Lateral Sclerosis","Spinal Cord Injury",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]