Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT06829212
Status:
RECRUITING
Last Update Posted:
2025-03-13
First Post:
2025-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Research on Wireless Brain Implant System for General Control of External Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011782', 'term': 'Quadriplegia'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D020526', 'term': 'Brain Stem Infarctions'}, {'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D010243', 'term': 'Paralysis'}, {'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': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain 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': 'D009336', 'term': 'Necrosis'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2025-02-05', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device-Related Adverse Events (AE)', 'timeFrame': 'Through study completion, an average of 7 months'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Through study completion, an average of 7 months'}, {'measure': 'Serious Adverse Event', 'timeFrame': 'Through study completion, an average of 7 months'}, {'measure': 'BPS', 'timeFrame': 'At an average of 4 to 7 months after implantation, both before and during the follow-up phases.', 'description': 'Bits per second, determined by the net number of correct targets selected per minute (NTPM) during task participation by the subject, and the grid size.'}, {'measure': 'Usage Time (hours/month)', 'timeFrame': 'At an average of 5 to 7 months after implantation, during the follow-up phases.', 'description': 'The amount of time the subject uses the experimental device each month.'}, {'measure': 'Accuracy', 'timeFrame': 'At an average of 5 to 7 months after implantation, during the follow-up phases.', 'description': 'The percentage of correctly completed commands from the total commands in the predefined task list, which are independently completed by the subject within a specified time.'}, {'measure': 'Psychological State', 'timeFrame': 'At an average of 4 to 7 months after implantation, both before and during the follow-up phases.', 'description': 'The subject and/or their caregiver will complete the checklist to assess psychological states and other relevant indicators (each question is graded from 1 to 5, with lower values being better).'}, {'measure': 'Caregiver Burden', 'timeFrame': 'At an average of 4 to 7 months after implantation, both before and during the follow-up phases.', 'description': "The subject's caregiver will complete the checklist to assess caregiver burden and other related indicators (each question is scored from 0 to 4, with lower scores being better)."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complete or Incomplete Paraplegia/quadriplegia', 'Spinal Cord Injury', 'Brainstem Stroke', 'Amyotrophic Lateral Sclerosis', 'Bilateral Upper Limb Amputation']}, 'descriptionModule': {'briefSummary': 'The clinical trial aims to evaluate the safety and efficacy of the minimally invasive, wireless brain-machine interface system (WRS) in enabling general brain control of external devices, such as a cursor and other assistive technologies, for paralyzed and amputee patients.\n\nWRS integrates a high-throughput, ultra-flexible neural electrode with an extremely small cross-sectional size-approximately one-hundredth the diameter of a human hair. Moreover, the implantable component is fully embedded within the body, leaving no visible external traces.', 'detailedDescription': "The investigators' technology is designed to assist paralyzed and amputee patients in regaining certain physical functions, thereby improving participants' overall quality of life and daily convenience.\n\nThe investigators hope to enable participants to achieve general control over external devices through neural signals in this clinical trial. This eliminates the need for manual manipulation to control devices such as a cursor or other assistive technologies, which can be operated solely through thought. Such advancements will facilitate enhanced communication with loved ones, support the acquisition of new skills, and provide more accessible opportunities for entertainment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 18-80 years (inclusive), any gender.\n* Diagnosed with spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis, or other motor neuron diseases causing partial or complete paralysis, or bilateral upper limb amputation.\n* Diagnosis stable for at least 6 months before screening, with the condition present for at least 1 year.\n* Willing to follow the study protocol and attend all visits, with or without caregiver assistance.\n* Informed consent signed by participant and/or caregiver, with full understanding of the trial's purpose.\n\nExclusion Criteria:\n\n* Previous implantation of metal objects or devices (except dental implants or non-impacting implants).\n* Long-term use of anticoagulants/antiplatelets with insufficient cessation, or abnormal coagulation test results.\n* Unable to tolerate anesthesia or surgery.\n* Severe neurological disorders or brain injury leading to significant dysfunction.\n* Scalp conditions that may impair wound healing.\n* Acute or severe infections.\n* Cognitive impairment or psychiatric disorders.\n* Severe dysfunction of vital organs, malignancies, or autoimmune diseases.\n* Life expectancy under 1 year.\n* Drug or alcohol abuse.\n* Pregnant, breastfeeding, or planning pregnancy during the study.\n* Other conditions deemed unsuitable by the investigator."}, 'identificationModule': {'nctId': 'NCT06829212', 'acronym': 'RISE', 'briefTitle': 'Research on Wireless Brain Implant System for General Control of External Devices', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai StairMed Technology Co., Ltd.'}, 'officialTitle': 'A Prospective Clinical Trial to Evaluate the Safety and Efficacy of Implantable Wireless Recording System (WRS) for General Control of External Devices in Paralyzed/Amputee Patients', 'orgStudyIdInfo': {'id': 'PI2302-CL-01-001'}, 'secondaryIdInfos': [{'id': '2024-1325', 'type': 'OTHER', 'domain': 'Huashan Hospital Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Implantation', 'description': 'Implantation of the WRS64', 'interventionNames': ['Device: WRS']}], 'interventions': [{'name': 'WRS', 'type': 'DEVICE', 'description': 'WRS is a minimally invasive, wireless brain-machine interface system, consisting of a wireless implanted neural signal collector(Model: WRS64), data energy transmitter(Model: DTC01/02), and a brain function information management platform software(Model: SW01).', 'armGroupLabels': ['Implantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junfeng Lu, Dr.', 'role': 'CONTACT', 'email': 'sherley_76@163.com', 'phone': '021-54601999'}], 'facility': 'Huashan Hospital Affiliated to Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Stairmed Clinical team', 'role': 'CONTACT', 'email': 'kongcen@stairmed.com', 'phone': '021-80510178'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai StairMed Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Huashan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}