Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-02-02 @ 8:09 AM
Study NCT ID:
NCT06511934
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2024-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020526', 'term': 'Brain Stem Infarctions'}, {'id': 'D011782', 'term': 'Quadriplegia'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013118', 'term': 'Spinal Cord 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': 2}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2024-07-08', 'studyFirstSubmitQcDate': '2024-07-16', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant', 'timeFrame': '1 year', 'description': 'To determine the safety of the Sensor and overall safety of the System. Participants will be considered a success for this safety measure if they are successfully implanted with the Sensor(s) and:\n\n1. the sensors are not explanted for safety reasons during the one-year post-implant evaluation period.\n2. there are no device-related Serious Adverse Events that result in death or permanently increased disability during the one-year post-implant evaluation period.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Brainstem Stroke', 'ALS', 'Tetraplegia', 'Spinal Cord Injuries', 'Cervical Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': "People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.", 'detailedDescription': 'The goal of this project is to advance the methods by which people with tetraplegia can gain intuitive, reliable control of communication apps on industry-standard tablet computers through use of an intracortical brain-computer interface (iBCI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders\n* Complete or incomplete tetraplegia (quadriplegia)\n* Must live within a three-hour drive of the Study site\n* Prior enrollment in BrainGate2 clinical trial (NCT00912041)\n\nExclusion Criteria:\n\n* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses\n* Chronic oral or intravenous steroids or immunosuppressive therapy\n* Other serious disease or disorder that could seriously affect ability to participate in the study\n\n(There are additional exclusion criteria)'}, 'identificationModule': {'nctId': 'NCT06511934', 'acronym': 'BG-Tablet-01', 'briefTitle': 'Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Intuitive, Complete Neural Control of Tablet Computers for Communication', 'orgStudyIdInfo': {'id': '2009P000505 (BG-Tablet-01)'}, 'secondaryIdInfos': [{'id': 'U01DC017844', 'link': 'https://reporter.nih.gov/quickSearch/U01DC017844', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BrainGate Neural Interface System', 'description': 'Device: BrainGate Neural Interface System', 'interventionNames': ['Device: BrainGate Neural Interface System']}], 'interventions': [{'name': 'BrainGate Neural Interface System', 'type': 'DEVICE', 'description': 'Placement of the BrainGate2 sensor(s) into arm-hand motor-related cortex.', 'armGroupLabels': ['BrainGate Neural Interface System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leigh R Hochberg, MD, PhD', 'role': 'CONTACT', 'email': 'clinicaltrials@braingate.org', 'phone': '617-724-9247'}], 'facility': 'Masssachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Leigh R Hochberg, MD, Ph.D', 'role': 'CONTACT', 'email': 'lhochberg@mgh.harvard.edu', 'phone': '617-724-9247'}], 'overallOfficials': [{'name': 'Leigh R Hochberg, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leigh R. Hochberg, MD, PhD.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brown University', 'class': 'OTHER'}, {'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Neurologist', 'investigatorFullName': 'Leigh R. Hochberg, MD, PhD.', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}