Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-26 @ 6:39 PM
Study NCT ID:
NCT04546451
Status:
COMPLETED
Last Update Posted:
2023-06-01
First Post:
2020-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Countervail Cognitive and Cerebral Decline in Mild Cognitive Impairment Patients Using Non-medical Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Patients will receive the information that 2 interventions to improve cognitive function in Mild Cognitive Impairment will be compared and that assignment to the interventions is random for scientific reasons.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 experimental conditions (Music practice vs. Psychomotor training) and 1 passive control condition'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-30', 'studyFirstSubmitDate': '2020-08-29', 'studyFirstSubmitQcDate': '2020-09-04', 'lastUpdatePostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive Telephone Screening Instrument (COGTEL)', 'timeFrame': '6 months', 'description': 'This test can be applied by telephone or face-to-face (in this study we will apply the face-to-face method). The outcome consists of increase or less decrease (experimental group 1 or 2 vs. the control group) of the total weighted score at the COGTEL test directly after the 6 months interventions as compared to directly before the interventions.\n\nThe COGTEL test provides a main weighted score of core cognitive function, it comprises 6 subtests covering prospective memory, short- and long-term verbal memory, working memory (digit span), verbal fluency and inductive reasoning.\n\nCOGTEL main weighted score: COGTEL Total score = 7.2 x Prospective Memory score + 1.0 x Verbal Short-Term Memory score + 0.9 x Verbal Long-Term Memory score + 0.8 x Working Memory score + 0.2 x Verbal Fluency score + 1.7 x Inductive Reasoning score\n\n(Kliegel, Martin, \\& Jager, 2007, doi:10.3200/JRLP.141.2.147-172) (lhle et al., 2017, doi:10.1159/000479680)'}], 'secondaryOutcomes': [{'measure': 'Individual subtests of the COGTEL (Cognitive Telephone Screening Instrument)', 'timeFrame': '6 months', 'description': 'Individual subtests of the COGTEL: prospective memory, short- and long-term verbal memory, working memory (digit span), verbal fluency, and inductive reasoning; the outcome consists of increase or less decrease (experimental group 1 or 2 vs. the control group) of each subtest score directly after the 6 months interventions as compared to directly before the interventions.'}, {'measure': 'D2-R test', 'timeFrame': '6 months', 'description': 'D2-R test (attention, processing speed): correct responses/hits minus errors/omissions; the outcome consists of increase or less decrease (experimental group 1 or 2 vs. the control group) of the total score directly after the 6 months interventions as compared to directly before the interventions.'}, {'measure': 'Trail making test', 'timeFrame': '6 months', 'description': 'Trail making test A (visual processing speed) \\& B (visual processing speed \\& cognitive flexibility): time to complete the test A and B; the outcome consists in decrease or less increase in time to complete the tests (experimental group 1 or 2 vs. the control group) directly after the 6 months interventions as compared to directly before the interventions.'}, {'measure': 'Go/No-Go', 'timeFrame': '6 months', 'description': 'Go/No-Go (inhibition): number of errors ; the outcome consists of decrease or less increase (experimental group 1 or 2 vs. the control group) of the total score directly after the 6 months interventions as compared to directly before the interventions.'}, {'measure': 'International Matrix Test (Oldenburg)', 'timeFrame': '6 months', 'description': 'Speech-in-noise perception test. The outcome is a score of Speech Reception Threshold (SRT), measured for both ears and each ear separately (Kollmeier et al., 2105, doi: 10.3109/14992027.2015.1020971).'}, {'measure': 'fMRI visual working memory task', 'timeFrame': '6 months', 'description': 'fMRI letter n-back visual working memory task (Migo et al., 2015, doi.org/10.1080/13825585.2014.894958): correct responses; the outcome consists of increase or less decrease (experimental group 1 or 2 vs. the control group) of the total score directly after the 6 months interventions as compared to directly before the interventions.'}, {'measure': 'Sensorimotor function', 'timeFrame': '6 months', 'description': 'Higher total score of the following sensorimotor tests in the 2 experimental intervention groups as compared to the active control group directly after the 6 months interventions as compared to directly before the interventions.\n\n1. Clock drawing test (assessing apraxia) (Aprahamian, Martinelli, Neri, \\& Yassuda, 2009, doi: 10.1590/S1980-57642009DN30200002)\n2. Purdue Pegboard (assessing manual dexterity) (Tiffin \\& Asher, 1948, doi: 10.1037/h0061266)\n3. Unipedal balance test (Bohannon \\& Tudini, 2018; doi:10.1016/j.physio.2018.04.001)\n4. Laterality test (assessing left/right judgements) (Williams et al., 2019, doi: 10.1016/j.msksp.2019.01.010)'}, {'measure': 'Short Version of the Amsterdam Instrumental Activity of the Daily Living Questionnaire (A-IADL-Q(SV))', 'timeFrame': '6 months', 'description': 'Daily living activities: improved daily living activities as measured by the A-IADL-Q(SV; Short Version of the Amsterdam Instrumental Activity of the Daily Living Questionnaire) in the 2 experimental intervention groups as compared to the control group directly after the 6 months interventions as compared to directly before the interventions (Jutten et al., 2017, doi:10.1016/j.dadm.2017.03.002).'}, {'measure': 'World Health Organization Quality of Life Instruments - short Version WHOQOL-BREF (abbreviated World Health Organization Quality of Life; WHO 1996)', 'timeFrame': '6 months', 'description': 'Subjective well-being: improved subjective well-being in both intervention groups as measured by the WHOQOL-BREF (1996) directly after the 6 months interventions as compared to directly before the interventions. (Organization, W. H. (1996). WHOQOL-BREF: introduction, administration, scoring and generic version of the assessment: field trial version, December 1996.)'}, {'measure': 'Emotional regulation questionnaire (ERQ)', 'timeFrame': '6 months', 'description': 'Emotional regulation: improved emotional regulation in the experimental groups as compared to the control group directly after the 6 months interventions as compared to directly before the interventions (Christophe et al., 2009 doi: 10.1016/j.erap.2008.07.001).'}, {'measure': 'Magnetization Prepared 2 Rapid Gradient Echo (MP2RAGE)', 'timeFrame': '6 months', 'description': 'MP2RAGE is an extension of the conventional MPRAGE pulse sequence widely used in clinical studies. It involves gray matter volume assessment, allowing to evaluate gray matter changes following learning of new skills (Marques \\& Gruetter, 2013, doi:10.1371/journal.pone.0069294).'}, {'measure': 'Functional MRI (fMRI)', 'timeFrame': '6 months', 'description': 'Letter N-back visual working memory task (Migo et al., 2015, doi.org/10.1080/13825585.2014.894958). Allows evaluating visual working memory performance following learning of new skills.'}, {'measure': 'Resting state functional MRI (RS-fMRI)', 'timeFrame': '6 months', 'description': 'RS-fMRI assesses activity in the Default Mode Network (DMN) reflecting global functional connectivity of the brain (Leonardi et al., 2013, doi: 10.1016/j.neuroimage.2013.07.019). Allows evaluating functional connectivity changes following learning of new skills.'}, {'measure': 'Diffusion Tensor Imaging (DTI)', 'timeFrame': '6 months', 'description': 'DTI allows computing i.a. Fractional Anisotropy for evaluating white matter integrity reflecting structural connectivity (Bosch et al., 2012, doi: 10.1016/j.neurobiolaging.2010.02.004). Allows evaluating structural connectivity changes following learning of new skills.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mild Cognitive Impairment', 'Randomized Controlled Trial', 'Non-medical interventions', 'Cognitive performance', 'Sensorimotor performance', 'Experience induced brain plasticity', 'Music Practice', 'Psychomotor training', 'Passive Control Group', 'Multivariate data-driven analyses'], 'conditions': ['Mild Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '36747142', 'type': 'DERIVED', 'citation': 'James CE, Stucker C, Junker-Tschopp C, Fernandes AM, Revol A, Mili ID, Kliegel M, Frisoni GB, Brioschi Guevara A, Marie D. Musical and psychomotor interventions for cognitive, sensorimotor, and cerebral decline in patients with Mild Cognitive Impairment (COPE): a study protocol for a multicentric randomized controlled study. BMC Geriatr. 2023 Feb 6;23(1):76. doi: 10.1186/s12877-022-03678-0.'}]}, 'descriptionModule': {'briefSummary': 'Cognitive decline represents a major threat among the deleterious effects of population aging. The investigators propose to conduct an RCT (randomized controlled trial) on the subpopulation of MCI patients, and examine whether intensive musical or psychomotor group interventions can improve their cognitive and sensorimotor functioning, as well as induce brain plasticity, compared to a passive healthy control group, matched for age, gender and education level. The 2 training regimens will take place twice a week over 6 months and will be provided by professionals in each field.', 'detailedDescription': 'Background Regular cognitive training can boost or maintain cognitive and brain functions known to decline with age. Most studies administered such cognitive training on a computer and in a lab setting. However, everyday life activities, like musical practice or physical exercise that are complex and variable, could be more successful at inducing transfer effects to different cognitive domains and maintaining motivation. "Body-mind exercises", like Tai Chi or psychomotor exercise, may also positively affect cognitive functioning in the elderly. We will investigate the influence of active music practice and psychomotor training over 6 months in Mild Cognitive Impairment patients from university hospital memory clinics on cognitive and sensorimotor performance and brain plasticity.\n\nMethods We aim to conduct a randomized controlled (RCT) multicenter intervention study on 32 Mild Cognitive Impairment (MCI) patients (60-80 years), divided over 2 experimental groups: 1) Music practice; 2) Psychomotor treatment. Controls will consist of a passive test-retest group of 16 age, gender and education level matched healthy volunteers.\n\nThe training regimens take place twice a week for 45 minutes over 6 months in small groups, provided by professionals, and patients should exercise daily at home. Data collection takes place at baseline (before the interventions), 3, and 6 months after training onset, on cognitive and sensorimotor capacities, subjective well-being, daily living activities, and via functional and structural neuroimaging. Considering the current constraints of the ongoing COVID-19 (COronaVIrus Disease of 2019) pandemic, recruitment and data collection takes place in 2 waves.\n\nDiscussion We will investigate whether musical practice or psychomotor exercise in small groups can improve cognitive, sensorimotor and brain functioning in MCI patients, and therefore provoke benefits for their daily life functioning and well-being.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. MCI diagnosis by experts at the memory clinics\n2. MMSE score (Mini-Mental State Examination) \\> 22 or MoCA (Montreal Cognitive Assessment) \\> 18\n3. Hospital Anxiety and Depression Scale (HADS) \\< 14 (\\< 7/21 for anxiety and \\< 7/21 for depression)\n4. Age between 60 and 80 years\n5. Right-handedness\n6. Fluent in French\n7. Able to give informed consent as documented by signature\n\nExclusion Criteria:\n\n1. Serious motor deficits\n2. Impaired/not-corrected hearing\n3. Serious physical and mental comorbidities\n4. Participation in physical or cognitive training over the last 12 months\n5. Maximum 5 years of official music education over the lifespan outside the school curriculum or during the last 3 years\n6. Intensive physical activity over the last 12 months (sports or body-mind exercises)\n7. Left-handed or ambidextrous\n8. MRI incompatibility (claustrophobia, cardiac stimulator, implants…)\n\nNota bene: for brain organizational reasons exclusively right-handed participants will be included. Right-handed persons represent more than 90% of the population (Isaacs, Barr, Nelson, \\& Devinsky, 2006., doi:10.1212/01.wnl.0000219623.28769.74.)'}, 'identificationModule': {'nctId': 'NCT04546451', 'acronym': 'COPE', 'briefTitle': 'Countervail Cognitive and Cerebral Decline in Mild Cognitive Impairment Patients Using Non-medical Interventions', 'organization': {'class': 'OTHER', 'fullName': 'School of Health Sciences Geneva'}, 'officialTitle': 'Musical and Psychomotor Interventions for Cognitive, Sensorimotor, and Cerebral Decline in Patients With Mild Cognitive Impairment (COPE): a Study Protocol for a Multicentric Randomized Controlled Study', 'orgStudyIdInfo': {'id': '99861'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music practice', 'description': 'Patients will receive Music Practice interventions of 45 minutes twice a week over 6 months, provided by a professional musician', 'interventionNames': ['Behavioral: Music practice']}, {'type': 'EXPERIMENTAL', 'label': 'Psychomotor therapy', 'description': 'Patients will receive Psychomotor interventions of 45 minutes twice a week over 6 months, provided by a professional psychomotor therapist', 'interventionNames': ['Behavioral: Psychomotor therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Passive control group', 'description': 'Healthy passive controls will pass all measurements without any intervention. The control group participants must adhere to the same inclusion and exclusion criteria as the experimental groups, except for an MCI diagnosis. Control participants will be matched to the experimental groups for age, gender and education level.'}], 'interventions': [{'name': 'Music practice', 'type': 'BEHAVIORAL', 'description': 'Patients will be trained to play a simple instrument (tongue-drum) in a group setting using different musical styles.', 'armGroupLabels': ['Music practice']}, {'name': 'Psychomotor therapy', 'type': 'BEHAVIORAL', 'description': 'Patients will be trained in body awareness and a wide range of of movement activities.', 'armGroupLabels': ['Psychomotor therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'CHUV: Centre Leenaards Memory Center', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': '1206', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'School of Health Sciences Geneva HES-SO', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Clara E. James, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland'}]}, 'ipdSharingStatementModule': {'url': 'https://yareta.unige.ch', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'After study completion (2022)', 'ipdSharing': 'YES', 'description': 'As soon as the data collection will be completed, all data and all other documents will be stored at YARETA, a FAIR (FAIR data are data which meet principles of findability, accessibility, interoperability, and reusability) digital solution for long-term preservation of research data for all Geneva Universities (https://yareta.unige.ch). The Geneva School of HEalth Sciences already possesses an organizational unit on the YARETA platform.\n\nThe datasets generated during the current study will not publicly available during data collection and analyses. After data collection and analyses completion, they will be published by our research team first, but they will be available in the future from the corresponding author on reasonable request.', 'accessCriteria': 'To be defined'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'School of Health Sciences Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Geneva', 'class': 'OTHER'}, {'name': 'University of Geneva, Switzerland', 'class': 'OTHER'}, {'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}