Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT03545451
Status:
UNKNOWN
Last Update Posted:
2018-10-11
First Post:
2018-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neurofeedback Rehabilitation Based on Motor Imaging in Patients in the Immobilization Phase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2018-04-05', 'studyFirstSubmitQcDate': '2018-05-22', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance', 'timeFrame': 'week 1', 'description': 'total displacement fo the avatar within the game'}], 'secondaryOutcomes': [{'measure': 'electroencephalography activity', 'timeFrame': 'week 1, 2, 3, 4, 5 and 6', 'description': 'amplitude of the oscillatory activity'}, {'measure': 'functional brain MRI', 'timeFrame': 'week 1 and 6', 'description': 'BOLD signal'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EEG, neurofeedback, fMRI, ALS, surgery, upper limbs'], 'conditions': ['Healthy Subjects, Patients With Amyotrophic Lateral Sclerosis, Patients With Shoulder Surgery']}, 'descriptionModule': {'briefSummary': "As the prevalence of motor impairment increases with age, the proportion of the population affected by physical limitations is likely to increase in the coming years, considering that one in three people will be over 60 in 2050 (compared to one in five in 2005, INSEE projections). The possibility of reducing recovery time and / or improving the improvement of motor deficits is today a public health issue. The possibility of developing new therapeutic tools using innovative motor imaging rehabilitation technologies is an opportunity to offer rehabilitation adapted to specific disorders, personalized in relation to the patient's performance, and in continuity with the therapist. In this research project, we will use the principle of neurofeedback rehabilitation (EEG) based on motor imaging with a brain-computer interface. Feedback will consist of therapeutic video games.Here, we will test the feasibility of such approach in 10 healthy subjects, 10 patients with amyotrophic lateral sclerosis and 10 patients with uppel shoulder surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCommon to the 3 populations concerned:\n\n* patients or subjects of both sexes;\n* age: 18-70 years;\n* ability to give consent in writing;\n* Health Insurance.\n\n a) SLA:\n* patients with amyotrophic lateral sclerosis (defined according to the El Escorial criteria: possible, probable or definite), at the time of diagnosis;\n* Percentage of forced vital capacity (FVC) ≥ 65% of the predicted value for age, gender and size.\n\n b) Patients after a shoulder trauma: patients with scheduled shoulder surgery. c) Healthy subjects.\n\nExclusion Criteria:\n\n* Dementia (MMSE score \\<24/30)\n* Pregnancy or patient not having effective contraception.\n* Other neurological, psychiatric or orthopedic disease leading to a motor handicap or an inability to correctly realize the experimental paradigm: interfering with the evaluation of the movements of the upper limb, incapacity to realize the mental imagery of the movement.\n* Visual impairment resulting in an inability to properly view the computer screen.\n* History of epilepsy or active epilepsy.\n* Contraindication to MRI: cardiac or neuronal simulator, ferromagnetic surgical clips, implants and metal objects, intraocular foreign bodies, claustrophobia\n* Persons under guardianship, trusteeship or any other administrative or judicial measure of deprivation of rights and liberty\n* Subject in the exclusion period of another interventional research or participating in any other interventional research or therapeutic trial\n* Presence of another severe progressive pathology'}, 'identificationModule': {'nctId': 'NCT03545451', 'acronym': 'REMINARY', 'briefTitle': 'Neurofeedback Rehabilitation Based on Motor Imaging in Patients in the Immobilization Phase', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Neurofeedback Rehabilitation Based on Motor Imaging in Patients in the Immobilization Phase', 'orgStudyIdInfo': {'id': 'K170502J'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neurofeedback rehabilitation with videogames', 'description': 'Neurofeedback rehabilitation with videogames', 'interventionNames': ['Device: Videogames']}], 'interventions': [{'name': 'Videogames', 'type': 'DEVICE', 'description': 'Videogames', 'armGroupLabels': ['Neurofeedback rehabilitation with videogames']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean Christophe CORVOL, MD', 'role': 'CONTACT'}], 'facility': 'Hopital PITIE SALPETRIERE', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Jean Christophe Corvol, MD, PHD', 'role': 'CONTACT', 'email': 'jean-christophe.corvol@aphp.fr', 'phone': '01 42 16 57 72', 'phoneExt': '0033'}], 'overallOfficials': [{'name': 'Jean Christophe Corvol, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Groupe Hospitalier Pitié-Salpêtrière Paris, France, 75013'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}