Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT06429735
Status:
RECRUITING
Last Update Posted:
2025-08-28
First Post:
2024-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precise Robotically IMplanted Brain-Computer InterfacE
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': 'D010243', 'term': 'Paralysis'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], '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': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2031-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2024-05-21', 'studyFirstSubmitQcDate': '2024-05-21', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device-Related Adverse Events (AE)', 'timeFrame': '12 months post-implant'}, {'measure': 'Procedure-Related Adverse Events (AE)', 'timeFrame': '12 months post-implant'}], 'secondaryOutcomes': [{'measure': 'Device-Related Adverse Events (AE)', 'timeFrame': 'Up to 72 months post-implant'}, {'measure': 'Procedure-Related Adverse Events (AE)', 'timeFrame': 'Up to 72 months post-implant'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['spinal cord injury', 'SCI', 'BCI', 'brain computer interface', 'ALS', 'quadriplegia', 'tetraplegic', 'paralysis'], 'conditions': ['Tetraplegia/Tetraparesis', 'Quadriplegia', 'Cervical Spinal Cord Injury', 'Amyotrophic Lateral Sclerosis', 'Quadriplegia/Tetraplegia', 'Tetraplegic; Paralysis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://neuralink.com/', 'label': 'https://neuralink.com/'}]}, 'descriptionModule': {'briefSummary': 'The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 Robot device designs in participants with tetraparesis or tetraplegia. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '22 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': 'NCT06429735', 'acronym': 'PRIME', 'briefTitle': 'Precise Robotically IMplanted Brain-Computer InterfacE', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neuralink Corp'}, 'officialTitle': 'PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices', 'orgStudyIdInfo': {'id': 'N1-EFS-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neuralink N1 Implant and R1 Robot', 'description': 'Implantation of the N1 Implant by the R1 Robot.', 'interventionNames': ['Device: N1 Implant', 'Device: R1 Robot']}], 'interventions': [{'name': 'N1 Implant', 'type': 'DEVICE', 'otherNames': ['Neuralink N1 Implant, N1, Telepathy, Link'], 'description': 'The N1 Implant is a type of implantable brain-computer interface', 'armGroupLabels': ['Neuralink N1 Implant and R1 Robot']}, {'name': 'R1 Robot', 'type': 'DEVICE', 'otherNames': ['R1, Neuralink R1 Robot'], 'description': 'The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.', 'armGroupLabels': ['Neuralink N1 Implant and R1 Robot']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Francisco Ponce, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Barrow Neurological Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan Jagid, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Neuralink Clinical Team', 'role': 'CONTACT', 'email': 'clinical-team-ct@neuralink.com', 'phone': '(877) 398-4465'}], 'overallOfficials': [{'name': 'Francisco Ponce, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barrow Neurological Institute'}, {'name': 'Jonathan Jagid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neuralink Corp', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}