Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-30 @ 2:50 PM
Study NCT ID:
NCT05635656
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2022-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Solutions for Concussion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D038223', 'term': 'Post-Concussion Syndrome'}, {'id': 'D051298', 'term': 'Post-Traumatic Headache'}], 'ancestors': [{'id': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}, {'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-16', 'studyFirstSubmitDate': '2022-11-02', 'studyFirstSubmitQcDate': '2022-11-22', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety of new digital solutions', 'timeFrame': 'Will be assessed at three different time points: After each usability testing during the iterative development cycles (T1 and T2) and after the home-testing period (T3).', 'description': 'Description of the frequency and severity of adverse events, serious adverse events and unexpected serious adverse events'}], 'primaryOutcomes': [{'measure': 'Usability of new digital solutions for symptom mapping and home-based biofeedback treatment in patients with PPCS/PTH', 'timeFrame': 'Will be assessed at three different time points: After each usability testing during the iterative development cycles (T1 and T2) and after the home-testing period (T3).', 'description': '\\- Description mHealth App Usability Questionnaire scores in the target user group; and Mobile App Rating Scale scores by an independent group of clinicians and researchers'}], 'secondaryOutcomes': [{'measure': 'Feasibility and adherence of new digital solutions', 'timeFrame': 'Will be assessed after the home-testing period (T3)', 'description': '* Number of days with logged symptom data during a 4-week home-testing period\n* Number of biofeedback sessions and mean change in biofeedback scores throughout the testing period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-Concussion Syndrome', 'Post-Traumatic Headache']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to develop new digital solutions for patients with prolonged postconcussion symptoms, and investigate its usability, feasibility, and safety. The digital solutions consist of a 1) symptom mapping and clinical decision support system, and 2) a research-based system for home-based biofeedback treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 or older at the time of inclusion.\n* Mild TBI as defined by having sustained a head injury with observed or self-reported alteration of consciousness, amnesia, or other relevant acute symptoms.\n* PPCS according to the ICD-10 research criteria and PTH according to International Classification of Headache Disorders 3rd edition (ICHD-3). Operationalized as reporting 3 or more symptoms (including headache) on a moderate or greater intensity level on the RPSQ.\n* Proficient in Norwegian language (oral and written)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Serious psychiatric or somatic disease, or other patient-related factors, that based on an evaluation of the study personnel responsible for inclusion, will provide obvious challenges for adhering to the protocol, including using the devices.\n* Less than three months of experience with smartphones\n* Not having access to an iOS or Android smartphone'}, 'identificationModule': {'nctId': 'NCT05635656', 'acronym': 'DiSCo', 'briefTitle': 'Digital Solutions for Concussion', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'Digital Symptom Mapping and Home-based Biofeedback Treatment for Adults with Persistent Postconcussion Symptoms: a Development and Usability Study', 'orgStudyIdInfo': {'id': '422538'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital symptom mapping and biofeedback treatment', 'interventionNames': ['Device: Digital symptom mapping and biofeedback treatment']}], 'interventions': [{'name': 'Digital symptom mapping and biofeedback treatment', 'type': 'DEVICE', 'description': 'Digital symptom mapping and biofeedback treatment', 'armGroupLabels': ['Digital symptom mapping and biofeedback treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'St. Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}