[
  {
    "retrieved": "2026-09-23",
    "hasResults": false,
    "protocolSection": {
      "identificationModule": {
        "nctId": "NCT07224256",
        "orgStudyIdInfo": {
          "id": "N1-EFS-200"
        },
        "organization": {
          "fullName": "Neuralink Corp",
          "class": "INDUSTRY"
        },
        "briefTitle": "VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration",
        "officialTitle": "VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration"
      },
      "statusModule": {
        "statusVerifiedDate": "2025-10",
        "overallStatus": "RECRUITING",
        "expandedAccessInfo": {
          "hasExpandedAccess": false
        },
        "startDateStruct": {
          "date": "2025-10-03",
          "type": "ACTUAL"
        },
        "primaryCompletionDateStruct": {
          "date": "2028-10",
          "type": "ESTIMATED"
        },
        "completionDateStruct": {
          "date": "2031-10",
          "type": "ESTIMATED"
        },
        "studyFirstSubmitDate": "2025-10-13",
        "studyFirstSubmitQcDate": "2025-10-31",
        "studyFirstPostDateStruct": {
          "date": "2025-11-04",
          "type": "ACTUAL"
        },
        "lastUpdateSubmitDate": "2025-10-31",
        "lastUpdatePostDateStruct": {
          "date": "2025-11-04",
          "type": "ACTUAL"
        }
      },
      "designModule": {
        "studyType": "INTERVENTIONAL",
        "phases": [
          "NA"
        ],
        "designInfo": {
          "allocation": "NA",
          "interventionModel": "SINGLE_GROUP",
          "primaryPurpose": "OTHER",
          "maskingInfo": {
            "masking": "NONE"
          }
        },
        "enrollmentInfo": {
          "count": 6,
          "type": "ESTIMATED"
        }
      },
      "outcomesModule": {
        "primaryOutcomes": [
          {
            "measure": "Device-Related Adverse Events (AE)",
            "description": "The proportion of subjects with device-related adverse events (AEs) at the 12-month follow-up visit.",
            "timeFrame": "12 months post-implant"
          },
          {
            "measure": "Procedure-Related Adverse Events (AE)",
            "description": "The proportion of subjects with procedure-related adverse events (AEs) at the 12-month follow-up visit.",
            "timeFrame": "12 months post-implant"
          }
        ],
        "secondaryOutcomes": [
          {
            "measure": "Long-term Device-Related Adverse Events (AE)",
            "description": "The proportion of subjects with device-related adverse events (AEs) up to the 48-month long-term follow-up visit.",
            "timeFrame": "Up to 48 months post-implant"
          },
          {
            "measure": "Long-term Procedure-Related Adverse Events (AE)",
            "description": "The proportion of subjects with procedure-related adverse events (AEs) up to the 48-month follow-up visit.",
            "timeFrame": "Up to 48 months post-implant"
          },
          {
            "measure": "Preliminary efficacy of the R1 Robot",
            "description": "Preliminary efficacy of the R1 Robot will be evaluated by measuring the following percent of electrodes inserted (reported as electrodes inserted / total electrodes).",
            "timeFrame": "During surgical implantation procedure"
          },
          {
            "measure": "Preliminary efficacy of the N1 Implant",
            "description": "Preliminary efficacy of the N1 Implant will be evaluated by measuring the following BCI performance for speech, quantified by measuring the monthly maximum correct word per minute (CWPM).",
            "timeFrame": "Up to 48 months post-implant"
          }
        ]
      }
    }
  },
  {
    "retrieved": "2026-09-23",
    "hasResults": false,
    "protocolSection": {
      "identificationModule": {
        "nctId": "NCT06700304",
        "orgStudyIdInfo": {
          "id": "N1-EFS-002"
        },
        "organization": {
          "fullName": "Neuralink Corp",
          "class": "INDUSTRY"
        },
        "briefTitle": "CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices",
        "officialTitle": "CAN-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices",
        "acronym": "CAN-PRIME"
      },
      "statusModule": {
        "statusVerifiedDate": "2025-05",
        "overallStatus": "RECRUITING",
        "expandedAccessInfo": {
          "hasExpandedAccess": false
        },
        "startDateStruct": {
          "date": "2024-11-20",
          "type": "ACTUAL"
        },
        "primaryCompletionDateStruct": {
          "date": "2027-11-30",
          "type": "ESTIMATED"
        },
        "completionDateStruct": {
          "date": "2030-11-30",
          "type": "ESTIMATED"
        },
        "studyFirstSubmitDate": "2024-11-15",
        "studyFirstSubmitQcDate": "2024-11-19",
        "studyFirstPostDateStruct": {
          "date": "2024-11-21",
          "type": "ACTUAL"
        },
        "lastUpdateSubmitDate": "2025-05-27",
        "lastUpdatePostDateStruct": {
          "date": "2025-05-31",
          "type": "ACTUAL"
        }
      },
      "designModule": {
        "studyType": "INTERVENTIONAL",
        "phases": [
          "NA"
        ],
        "designInfo": {
          "allocation": "NA",
          "interventionModel": "SINGLE_GROUP",
          "interventionModelDescription": "The study is a prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS)",
          "primaryPurpose": "OTHER",
          "maskingInfo": {
            "masking": "NONE"
          }
        },
        "enrollmentInfo": {
          "count": 6,
          "type": "ESTIMATED"
        }
      },
      "outcomesModule": {
        "primaryOutcomes": [
          {
            "measure": "The Rate of Device-Related Adverse Events (AE)",
            "timeFrame": "12 months post-implant"
          },
          {
            "measure": "The Rate of Procedure-Related Adverse Events (AE)",
            "timeFrame": "12 months post-implant"
          }
        ],
        "secondaryOutcomes": [
          {
            "measure": "The Rate of Device-Related Adverse Events (AE)",
            "timeFrame": "Up to 36 months post-implant"
          },
          {
            "measure": "The Rate of Procedure-Related Adverse Events (AE)",
            "timeFrame": "Up to 36 months post-implant"
          },
          {
            "measure": "Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study",
            "timeFrame": "From baseline to 3-, 6-, 9-, and 12-months post-implantation"
          },
          {
            "measure": "Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase",
            "timeFrame": "From baseline to 36-months post-implantation"
          },
          {
            "measure": "Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study",
            "timeFrame": "From baseline to 3-, 6-, 9-, and 12-months post-implantation"
          },
          {
            "measure": "Change in Patient Health Questionnaire-9 (PHQ-9) score during the Long-term Follow-up Phase",
            "timeFrame": "From baseline to 36-months post-implantation"
          },
          {
            "measure": "Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study",
            "timeFrame": "From baseline to 3-, 6-, 9-, and 12-months post-implantation"
          },
          {
            "measure": "Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Long-term Follow-up Phase",
            "timeFrame": "From baseline to 36-months post-implantation"
          }
        ]
      }
    }
  }
]