Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-03-03 @ 12:02 AM
Study NCT ID:
NCT03787420
Status:
UNKNOWN
Last Update Posted:
2018-12-26
First Post:
2018-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-24', 'studyFirstSubmitDate': '2018-10-25', 'studyFirstSubmitQcDate': '2018-12-24', 'lastUpdatePostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1- Amyotrophic Lateral Sclerosis Supportive Care Needs', 'timeFrame': '30mins', 'description': 'To comprehensively assess the perceived supportive care needs of patients with ALS.'}, {'measure': 'Part 2 - Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revisedclinical study', 'timeFrame': 'one week', 'description': 'We try to understand the validity of the system. This measurement can help us know that our system could be beneficial or not on the quality of life in patient with ALS.'}], 'secondaryOutcomes': [{'measure': 'Part 2 - Beck Depression Inventoryc', 'timeFrame': 'one week', 'description': 'We try to understand the validity of the system. This measurement can help us know that our system could be beneficial or not on the degree of depression of life in patient with ALS.'}, {'measure': 'Caregiver Burden Scale', 'timeFrame': 'one week', 'description': "We try to understand the validity of the system. This measurement can help us know that our system could be beneficial or not on the burden in patient's caregiver."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ALS (Amyotrophic Lateral Sclerosis)']}, 'descriptionModule': {'briefSummary': 'This project aims to develop a smart communication system for patients with amyotrophic lateral sclerosis (ALS), especially for stage 3 and stage 4 (late stage). Patients with ALS will be able to communicate with outer environment by means of mental control or eye tracking control, which would increase their life quality. This integrated research project includes experts from different domains and proposes a solution for smart communication system.', 'detailedDescription': 'A multi-function brain- computer interface (BCI) communication system will be developed by combining a BCI system (subproject 1) and a 3D electro-cap (subproject 3). Then, this system and an eye-controlled device (subject 2) are further integrated to a smart communication system. The outputs of the system are presented with the original voice the ALS patients, which will be achieved by using the voice reconstruction technology (subproject 4) in this project. All the user-interfaces of the BCI and eye tracking systems will be re-deigned by employing human factors engineering to increase the usability of the proposed smart communication system for ALS. Finally, the validity of the system in improving the life quality of ALS will be assessed through clinical study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Part one:\n\nInclusion Criteria:\n\n* ALS diagnostic criteria (Brooks et al., 2000).Must have the following characteristics:\n\n 1. Degeneration of motor neurons (LMN) by clinical, electrophysiological or neuropathological evidence.\n 2. Degeneration of upper motor neurons (UMN) is demonstrated by clinical examination.\n 3. According to the medical history or examination, the symptoms or signs gradually disappear in a certain part.\n\nAlso, there are no features:\n\n1. Electrophysiological or pathological evidence of other diseases that may explain signs of LMN and/or UMN degradation\n2. Neuroimaging evidence of other diseases that may explain the observed clinical electrophysiological signs.\n\n * Use Mandarin as the main language.\n * Age limits minimum is 20\n\nExclusion Criteria:\n\n* Concomitant other central nervous disorders that interfere with their cognitive function, such as dementia, severe depression, and psychosis.\n* The questionnaire cannot be completed without the assistance of others.\n\nPart two:\n\nInclusion Criteria:\n\n* ALS diagnostic criteria (Brooks et al., 2000).\n* Use Mandarin as the main language.\n* Age limits minimum is 20\n* In everyday oral communication, people who are consciously difficult.\n* Ability to perform equipment wear and system operators.\n\nExclusion Criteria:\n\n* Concomitant other central nervous disorders that interfere with their cognitive function, such as dementia, severe depression, and psychosis.\n* After correction, the visual acuity cannot see the communication board.\n* The scalp is sensitive or there is deep brain stimulation, etc. It is not applicable to brain wave measurement.\n* -The questionnaire cannot be completed without the assistance of others.'}, 'identificationModule': {'nctId': 'NCT03787420', 'briefTitle': 'Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS', 'orgStudyIdInfo': {'id': '107-3011-F-027-002-'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'traditional communication system', 'interventionNames': ['Other: communication system']}, {'type': 'EXPERIMENTAL', 'label': 'intelligent communication system', 'interventionNames': ['Other: communication system']}], 'interventions': [{'name': 'communication system', 'type': 'OTHER', 'description': 'We will use the questionnaire "Amyotrophic Lateral Sclerosis Supportive Care Needs ,Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revised, Beck Depression Inventory and Caregiver Burden Scale.', 'armGroupLabels': ['intelligent communication system', 'traditional communication system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11217', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Cheng Liang Chou', 'role': 'CONTACT', 'email': 'cl_chou@vghtpe.gov.tw', 'phone': '+8862-28757296'}, {'name': 'SI-HUEI LEE', 'role': 'CONTACT', 'email': 'leesihuei@gmail.com', 'phone': '+886938591985'}], 'facility': 'Cancer Center, Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Cheng Liang Chou', 'role': 'CONTACT', 'email': 'cl_chou@vghtpe.gov.tw', 'phone': '+8862-28757296'}, {'name': 'SI-HUEI LEE', 'role': 'CONTACT', 'email': 'leesihuei@gmail.com', 'phone': '+886938591985'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}