Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT07224256
Status:
RECRUITING
Last Update Posted:
2025-11-04
First Post:
2025-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration
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': 'D020521', 'term': 'Stroke'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D013060', 'term': 'Speech'}, {'id': 'D004401', 'term': 'Dysarthria'}], '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': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014705', 'term': 'Verbal Behavior'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001184', 'term': 'Articulation Disorders'}, {'id': 'D013064', 'term': 'Speech Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2031-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-31', 'studyFirstSubmitDate': '2025-10-13', 'studyFirstSubmitQcDate': '2025-10-31', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device-Related Adverse Events (AE)', 'timeFrame': '12 months post-implant', 'description': 'The proportion of subjects with device-related adverse events (AEs) at the 12-month follow-up visit.'}, {'measure': 'Procedure-Related Adverse Events (AE)', 'timeFrame': '12 months post-implant', 'description': 'The proportion of subjects with procedure-related adverse events (AEs) at the 12-month follow-up visit.'}], 'secondaryOutcomes': [{'measure': 'Long-term Device-Related Adverse Events (AE)', 'timeFrame': 'Up to 48 months post-implant', 'description': 'The proportion of subjects with device-related adverse events (AEs) up to the 48-month long-term follow-up visit.'}, {'measure': 'Long-term Procedure-Related Adverse Events (AE)', 'timeFrame': 'Up to 48 months post-implant', 'description': 'The proportion of subjects with procedure-related adverse events (AEs) up to the 48-month follow-up visit.'}, {'measure': 'Preliminary efficacy of the R1 Robot', 'timeFrame': 'During surgical implantation procedure', 'description': 'Preliminary efficacy of the R1 Robot will be evaluated by measuring the following percent of electrodes inserted (reported as electrodes inserted / total electrodes).'}, {'measure': 'Preliminary efficacy of the N1 Implant', 'timeFrame': 'Up to 48 months post-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).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['stroke', 'spinal cord injury', 'SCI', 'ALS', 'brain computer interface', 'BCI', 'PLS', 'voice', 'speech', 'dysarthria', 'neuralink'], 'conditions': ['Tetraplegia/Tetraparesis', 'Quadriplegia', 'Cervical Spinal Cord Injury', 'Amyotrophic Lateral Sclerosis', 'Quadriplegia/Tetraplegia', 'Tetraplegic; Paralysis', 'Stroke']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://neuralink.com/', 'label': 'https://neuralink.com/'}]}, 'descriptionModule': {'briefSummary': 'The VOICE Study is an early feasibility study to evaluate the initial clinical safety and efficacy of the N1 and R1 Systems device design concept in providing an ability to communicate. The Neuralink N1 Implant is intended to provide the ability to communicate to individuals with severe and irreversible speech production impairment. It is indicated for adults with neurological conditions of the central speech pathways who have impaired upper limb function. 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\nAdults with diagnosis of ALS, PLS, stroke, or Spinal Cord Injury who have severe speech impairment and impaired upper limb function.\n\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* 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* 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': 'NCT07224256', 'briefTitle': 'VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neuralink Corp'}, 'officialTitle': 'VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration', 'orgStudyIdInfo': {'id': 'N1-EFS-200'}}, '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': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nader Pouratian, MD', 'role': 'CONTACT', 'email': 'voice-study@neuralink.com', 'phone': '214-645-1355'}, {'name': 'Nader Pouratian, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Neuralink Clinical Team', 'role': 'CONTACT', 'email': 'voice-study@neuralink.com', 'phone': '+1 (650) 250-0520'}], 'overallOfficials': [{'name': 'Nader Pouratian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neuralink Corp', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}