Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-01 @ 10:33 PM
Study NCT ID:
NCT05951556
Status:
UNKNOWN
Last Update Posted:
2023-07-19
First Post:
2022-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telehealth Implementation of Brain-Computer Interface
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000080422', 'term': 'Locked-In Syndrome'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': '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': 'D011782', 'term': 'Quadriplegia'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Participants will be provided with device; telehealth appts will be utilized to direct setup and usage of the device.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-07-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2022-05-04', 'studyFirstSubmitQcDate': '2023-07-18', 'lastUpdatePostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Log of communication', 'timeFrame': 'From date of enrollment in study until the date of discontinuation of the intervention, whichever came first, assessed up to 100 months', 'description': 'Logs of any communication will be kept by monitoring number of accurate selections while utilizing the BCI.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['locked in syndrome'], 'conditions': ['Amyotrophic Lateral Sclerosis', 'Stroke']}, 'descriptionModule': {'briefSummary': 'Determine if Telehealth intervention can allow/empower a caregiver (who is untrained) to effectively implement and utilize a Brain-Computer Interface for communication with a participant who is "Locked in" following progression of Amyotrophic Lateral Sclerosis and other conditions.', 'detailedDescription': 'People with Amyotrophic Lateral Sclerosis (ALS) or other conditions such as a pontine stroke may develop a condition called Locked In Syndrome (LIS) where they are unable to use alternative communication strategies such as eyegaze to allow for communication for social needs or instruction to caregivers. Brain-Computer Interface (BCI) devices have been shown in the laboratory to allow participants to effectively communicate needs and engage in social communication. However, translation of this research to the home environment has been limited. In order to be a functional option for people to utilize, BCI needs to be much easier to set up and operate.\n\nThis study is designed to determine if telehealth intervention is sufficient to allow an untrained caregiver to set up and maintain a BCI for a person with a long-term communication difficulty given LIS.\n\nParticipants will receive a computer and associated hardware to allow for set up of the BCI. Videoconference support will be provided by the research team to allow the client and caregiver to set up the device in their home. Participants will hopefully be able to use the device to generate novel communication related to their care and engage in social needs with caregivers and/or family members. Communication that is generated will be logged and times that the participant is engaged in use of the BCI when not under direct support by the researchers will also be monitored.\n\nThe hypothesis is that telehealth support will be sufficient to allow for setting up the computer. If this is true, this will make it much easier for a client to engage in use of a BCI to allow for that communication versus the current need of traveling to a clinic or other specialized setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis leading to severe communication impairment\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05951556', 'briefTitle': 'Telehealth Implementation of Brain-Computer Interface', 'organization': {'class': 'OTHER', 'fullName': 'Shirley Ryan AbilityLab'}, 'officialTitle': 'Individualizing Home Use of an Electroencephalographic or EEG-based Brain-computer Interface (BCI) Using Telemedicine', 'orgStudyIdInfo': {'id': 'ShirleyRyanAbilityLab'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All Participants', 'description': 'All Participants will receive trial device and will be trained (via Telehealth) in its use.', 'interventionNames': ['Device: Use of BCI']}], 'interventions': [{'name': 'Use of BCI', 'type': 'DEVICE', 'description': 'Clients will utilize BCI with training to communicate wants and needs', 'armGroupLabels': ['All Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Edward C Hitchcock, OT/L', 'role': 'CONTACT', 'email': 'ehitchcock@sralab.org', 'phone': '312-238-2997'}], 'facility': 'ShirleyRyan AbilityLab', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Edward C Hitchcock, OT/L', 'role': 'CONTACT', 'email': 'ehitchcock@sralab.org', 'phone': '312 238 2997'}], 'overallOfficials': [{'name': 'Colin Franz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SRALAB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shirley Ryan AbilityLab', 'class': 'OTHER'}, 'collaborators': [{'name': 'Albany Stratton VA Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending MD, Principal investigator', 'investigatorFullName': 'Colin Franz', 'investigatorAffiliation': 'Shirley Ryan AbilityLab'}}}}