Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-28 @ 11:22 AM
Study NCT ID:
NCT06700304
Status:
RECRUITING
Last Update Posted:
2025-05-31
First Post:
2024-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011782', 'term': 'Quadriplegia'}, {'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D010243', 'term': 'Paralysis'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study is a prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2030-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2024-11-15', 'studyFirstSubmitQcDate': '2024-11-19', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-30', '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['brain computer interface', 'Neuralink N1 Implant', 'Neuralink', 'Robot', 'tetraparesis', 'tetraplegia', 'quadriplegia', 'ALS', 'spinal cord injury', 'Amyotrophic lateral sclerosis', 'chip', 'brain chip', 'External device control', 'Wireless implant', 'Neuroprosthetics', 'SCI', 'paralysis'], 'conditions': ['Tetraplegia/Tetraparesis', 'Quadriplegia', 'Quadriplegia/Tetraplegia', 'Cervical Spinal Cord Injury', 'Amyotrophic Lateral Sclerosis (ALS)', 'Spinal Cord Injury (Quadraplegia)', 'Spinal Cord Injury']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://neuralink.com/', 'label': 'Neuralink Website'}]}, 'descriptionModule': {'briefSummary': "The CAN-PRIME Study is to test the safety and functionality of Neuralink's N1 Implant and R1 Robot in people who have difficulty moving their arms and legs (tetraparesis or tetraplegia). The N1 Implant is a small, wireless device placed in the skull. It connects to tiny threads inserted into the brain by the R1 Robot, which is a machine designed to carefully place these threads. This study will help researchers learn how well the implant and robot work and if they are safe for use."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below\n* Life expectancy ≥ 12 months.\n* Ability to communicate in English\n* Presence of a stable caregiver\n\nExclusion Criteria:\n\n* Moderate to high risk for serious perioperative adverse events\n* Active implanted devices\n* Morbid obesity (Body Mass Index \\> 40)\n* History of poorly controlled seizures or epilepsy\n* History of poorly controlled diabetes\n* Requires magnetic resonance imaging (MRI) for any ongoing medical conditions\n* Acquired or hereditary immunosuppression\n* Use of smoking tobacco or other tobacco products\n* Psychiatric or psychological disorder\n* Brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy.\n* Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure'}, 'identificationModule': {'nctId': 'NCT06700304', 'acronym': 'CAN-PRIME', 'briefTitle': 'CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neuralink Corp'}, 'officialTitle': 'CAN-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices', 'orgStudyIdInfo': {'id': 'N1-EFS-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface', 'description': 'Open label', 'interventionNames': ['Device: N1 Implant', 'Device: R1 Robot']}], 'interventions': [{'name': 'N1 Implant', 'type': 'DEVICE', 'description': 'The N1 Implant is a type of implantable brain-computer interface.', 'armGroupLabels': ['CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface']}, {'name': 'R1 Robot', 'type': 'DEVICE', 'description': 'The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.', 'armGroupLabels': ['CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Dr. Andres Lozano', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Neuralink Clinical Team', 'role': 'CONTACT', 'email': 'clinical-team-ct@neuralink.com', 'phone': '(877) 398-4465'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neuralink Corp', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University Health Network, Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}