Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-01 @ 12:31 PM
Study NCT ID:
NCT01897818
Status:
UNKNOWN
Last Update Posted:
2013-07-12
First Post:
2013-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Communication by Brain - Computer Interface in Amyotrophic Lateral Sclerosis:Feasibility Study
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'lastUpdateSubmitDate': '2013-07-09', 'studyFirstSubmitDate': '2013-07-09', 'studyFirstSubmitQcDate': '2013-07-09', 'lastUpdatePostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the full achievement of "copy spelling" and "free spelling" tests session 1', 'timeFrame': '14 days after inclusion'}, {'measure': 'the full achievement of "copy spelling" and "free spelling" tests session 2', 'timeFrame': '28 days after inclusion'}]}, 'conditionsModule': {'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': 'ALS is a severe progressive neurodegenerative disease characterized by degeneration motor neurons leading to death in 3 to 5 years. Gradually in time, the patient deprived of all motor skills as well as the possibility of communication written and oral developing a state close Locked In Syndrome (LIS). The main objective is to establish the feasibility of brain-computer interface using the pathological condition, with dependent disabled subjects as a means of communication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age \\>= 18\n* have a diagnosis of ALS suspected, possible, probable with EMG\n* be able to follow the study process and to comply with the schedule of visits upon entry into the study\n* understand the purpose of the study\n* expressing P300 wave in the conditions of the study\n\nExclusion Criteria:\n\n* have a mental illness or clinical dementia defined clinically significant may hinder the patient's ability to follow the procedures of the study\n* have a significant history of photosensitive epilepsy\n* have a history of allergy to the gel used for the electrodes\n* Major protected by law (guardianship, curators)\n* have uncorrectable visual disorders\n* not being able to maintain a sitting position and focus on a computer screen for more than 30 min."}, 'identificationModule': {'nctId': 'NCT01897818', 'briefTitle': 'Communication by Brain - Computer Interface in Amyotrophic Lateral Sclerosis:Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'orgStudyIdInfo': {'id': '12-PP-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALS patients', 'interventionNames': ['Device: communication system P300 Speller']}], 'interventions': [{'name': 'communication system P300 Speller', 'type': 'DEVICE', 'armGroupLabels': ['ALS patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06202', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Claude DESNUELLE, Pr', 'role': 'CONTACT', 'email': 'desnuelle.c@chu-nice.fr'}, {'name': 'Claude DESNUELLE, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Hôpital de l'Archet I", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Claude DESNUELLE, Pr', 'role': 'CONTACT', 'email': 'desnuelle.c@chu-nice.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}