Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT04882527
Status:
COMPLETED
Last Update Posted:
2023-12-12
First Post:
2021-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modulating Prospective Memory in Older Adults With Non-invasive Brain Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2021-05-06', 'studyFirstSubmitQcDate': '2021-05-06', 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Self-rated prospective memory', 'timeFrame': 'Only at baseline session, after computer-based tasks, 10 minutes', 'description': 'Assessed with a questionnaire (PRMQ - Prospective Retrospective Memory Questionnaire).\n\nComparison to performance in other tasks.'}, {'measure': 'Self-rated metacognitive prospective memory', 'timeFrame': 'Only at stimulation session, after intervention, 10 minutes', 'description': 'Assessed with a questionnaire (MPMI - Metacognitive Prospective Memory Inventory).\n\nComparison to performance in other tasks.'}, {'measure': 'Stimulation Side-Effects', 'timeFrame': 'Only at stimulation session, after intervention, 3 minutes', 'description': 'Self-rating about adverse side effects during and after stimulation are assessed with a questionnaire.'}, {'measure': 'Naturalistic prospective memory', 'timeFrame': '5 minutes per session; retrieval within five days after each session', 'description': 'Assessed with a behavioral task. Number of correctly retrieved naturalistic prospective memory intentions.\n\nChange from baseline to intervention session, difference between intervention groups.'}, {'measure': 'Inhibition intra-individual coefficient of variation', 'timeFrame': 'During both sessions (for stimulation session: directly after intervention), 2 minutes', 'description': 'Assessed with a go/no-go computer task (TAP -Test of Attentional Performance). Variability of response times (i.e., within-person fluctuation in response latency) to go-stimuli.\n\nChange from baseline to intervention session, difference between intervention groups.'}, {'measure': 'Flexibility intra-individual coefficient of variation', 'timeFrame': 'During both sessions (for stimulation session: directly after intervention), 3 minutes', 'description': 'Assessed with flexibility computer task (TAP -Test of Attentional Performance). Variability of response times (i.e., within-person fluctuation in response latency).\n\nChange from baseline to intervention session, difference between intervention groups.'}, {'measure': 'Divided attention intra-individual coefficient of variation', 'timeFrame': 'During both sessions (for stimulation session: directly after stimulation), 3 minutes 30 seconds', 'description': 'Assessed with a computer-based task (Test of Attentional Performance). Variability of response times (i.e., within-person fluctuation in response latency).\n\nChange from baseline to intervention session, difference between intervention groups.'}], 'primaryOutcomes': [{'measure': 'Prospective memory performance', 'timeFrame': 'During both sessions (for stimulation session: during intervention), fixed to 14 minutes', 'description': 'Assessed with a computer task. Number of correct answers given to prospective memory stimuli.\n\nChange from baseline to intervention session, difference between intervention groups.'}, {'measure': 'Prospective memory reaction time', 'timeFrame': 'During both sessions (for stimulation session: during intervention), fixed to 14 minutes', 'description': 'Assessed with a computer task. Reaction times of answers given to prospective memory stimuli.\n\nChange from baseline to intervention session, difference between intervention groups.'}, {'measure': 'Executive controlling functioning', 'timeFrame': 'During both sessions (for stimulation session: during intervention), task fixed to 6 minutes', 'description': 'Assessed with a computer task (ANT - Attentional Network Task). Interference between answers given to congruent and incongruent stimuli.\n\nChange from baseline to intervention session, difference between intervention groups.'}, {'measure': 'Flexibility performance', 'timeFrame': 'During both sessions (for stimulation session: directly after intervention), 3 minutes', 'description': 'Assessed with a computer task (TAP- Test of Attentional Performance). Number of correct answers.\n\nChange from baseline to intervention session, difference between intervention groups.'}, {'measure': 'Inhibition errors', 'timeFrame': 'During both sessions (for stimulation session: directly after intervention), 2 minutes', 'description': 'Assessed with a computer task (Test of Attentional Performance). Sum of incorrect responses to no-go stimuli.\n\nChange from baseline to intervention session, difference between intervention groups.'}, {'measure': 'Divided attention misses', 'timeFrame': 'During both sessions (for stimulation session: directly after intervention), 3 minutes 30 seconds', 'description': 'Assessed with a computer task (TAP - Test of Attentional Performance). Sum of missed target stimuli.\n\nChange from baseline to intervention session, difference between intervention groups.'}, {'measure': 'Flexibility reaction-time', 'timeFrame': 'During both sessions (for stimulation session: directly after intervention), 3 minutes', 'description': 'Assessed with a computer task (TAP - Test of Attentional Performance). Mean/ median of reactions times of correct responses.\n\nChange from baseline to intervention session, difference between intervention groups.'}, {'measure': 'Inhibition reaction time', 'timeFrame': 'During both sessions (for stimulation session: directly after intervention), 2 minutes', 'description': 'Assessed with a go/no-go computer task (TAP -Test of Attentional Performance). Mean/ median of reactions times to correct responses.\n\nChange from baseline to intervention session, difference between intervention groups.'}, {'measure': 'Divided attention reaction time', 'timeFrame': 'During both sessions (for stimulation session: directly after stimulation), 3 minutes 30 seconds', 'description': 'Assessed with a computer-based task (Test of Attentional Performance). Median reaction time of correct answers.\n\nChange from baseline to intervention session, difference between intervention groups.'}], 'secondaryOutcomes': [{'measure': 'Alerting network functioning', 'timeFrame': 'During both sessions (for stimulation session: during intervention), task fixed to 6 minutes', 'description': 'Assessed with a computer task (ANT - Attentional Network Task). Contrasting reaction times of answers given to stimuli with alerting cues to those without alerting cues.\n\nChange from baseline to intervention session, difference between intervention groups.'}, {'measure': 'Orienting network functioning', 'timeFrame': 'During both sessions (for stimulation session: during intervention), task fixed to 6 minutes', 'description': 'Assessed with a computer task (ANT - Attentional Network Task). Contrasting reaction times of answers given to stimuli with reliable spatial cues to those without spatial cues.\n\nChange from baseline to intervention session, difference between intervention groups.'}, {'measure': 'Ongoing-task performance', 'timeFrame': 'During both sessions (for stimulation session: during intervention), fixed to 14 minutes', 'description': 'Assessed with a computer task. Number of correctly answered ongoing task stimuli in the course of the prospective memory task.\n\nChange from baseline to intervention session, difference between intervention groups.'}, {'measure': 'Ongoing-task reaction time', 'timeFrame': 'During both sessions (for stimulation session: during intervention), fixed to 14 minutes', 'description': 'Assessed with a computer task. Mean/median response time of correct ongoing task answers in the course of the prospective memory task.\n\nChange from baseline to intervention session, difference between intervention groups.'}, {'measure': 'Ongoing-task intra-individual coefficient of variation', 'timeFrame': 'During both sessions (for stimulation session: during intervention), fixed to 14 minutes', 'description': 'Assessed with a computer task. Variability of response times (i.e., within-person fluctuation in response latency) to ongoing task stimuli in the course of the prospective memory task.\n\nChange from baseline to intervention session, difference between intervention groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Aging']}, 'referencesModule': {'references': [{'pmid': '37549139', 'type': 'DERIVED', 'citation': 'Schmidt N, Menendez-Granda M, Munger R, Reber TP, Bayen UJ, Gumusdagli FE, Hering A, Joly-Burra E, Kliegel M, Peter J. Modulating prospective memory and attentional control with high-definition transcranial current stimulation: Study protocol of a randomized, double-blind, and sham-controlled trial in healthy older adults. PLoS One. 2023 Aug 7;18(8):e0289532. doi: 10.1371/journal.pone.0289532. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': "Prospective memory is the ability to remember to carry out intentions with a certain delay (e.g. remember to buy stamps when passing a postal office). Prospective memory tasks require a large degree of self-initiated retrieval and in the absence of a prompt to recall, people must 'remember to remember' by their own volition. Thus, prospective memory is a challenge - especially in old age with increasing health-related prospective memory demands.\n\nPrevious studies reported links between neural activity in specific brain regions and prospective memory performance. Yet, the mere occurrence of a change in brain activity in concomitance with performance of a behavioral task is not sufficient to confirm a causal relationship between the two phenomena. Therefore, this study aims to apply non-invasive brain stimulation to facilitate or inhibit activity in different brain regions presumed to be functionally associated with prospective memory. Additional to the prospective memory tasks, the investigators will implement control tasks (i.e., attention) to assess whether stimulation will specifically enhance prospective memory performance or whether other cognitive functions will be modulated additionally.\n\nIt is hypothesized that stimulation will lead to changes in prospective memory functioning. Further, the investigators expect that facilitation of attentional processes might be linked to prospective memory improvements.", 'detailedDescription': 'This study aims to modulate neural activity in the left and right inferior frontal lobe as well as in the right superior parietal lobe via high-definition transcranial direct current stimulation (HD-tDCS) in older adults. There is evidence from functional magnetic resonance imaging (fMRI) studies that these areas are involved in prospective memory performance in younger and older adults but a causal relation between activity in these areas and responses in prospective memory tasks has not been established so far.\n\nA double blind, sham-controlled, parallel group design will be applied. Healthy older adults (n=105) will participate in two separate sessions: During the first baseline session, no stimulation is applied. For the second session, participants will then be randomly assigned to one of seven experimental groups (cathodal vs. anodal right inferior frontal lobe (rIFL); cathodal vs. anodal left inferior frontal lobe (lIFL); cathodal vs. anodal right superior parietal lobe (rSPL); or sham). Real stimulation will be applied during 20 minutes with one Milliamp (mA). In case of sham stimulation (i.e., control intervention), the electrode positions and the attachment procedures correspond to those of real tDCS but the electrical current will only be ramped up to one mA and switched off completely after 30 s of stimulation.\n\nThe primary objective of this study is the modulation of prospective memory performance in a computer-based task via tDCS. Further, this study aims to clarify the role of attentional control for prospective memory performance, as both processes seem to recruit similar neural structures. Additionally, naturalistic and self-rated prospective memory performance will be assessed.\n\nIt is hypothesized that stimulation of the right inferior frontal lobe will lead to changes in prospective memory performance and attentional processes. Whether cathodal or anodal stimulation will enhance performance is not clear yet, since previous fMRI studies were inconsistent about activity changes in older adults. Further, the investigators expect that anodal stimulation of the left inferior frontal cortex may lead to faster responses to prospective memory stimuli, whereas cathodal stimulation of the same area may lead to prolonged reaction times. It is hypothesized that attentional control will not be affected by stimulation of the left inferior frontal lobe. Finally, the investigators expect that anodal stimulation of the right superior parietal cortex will lead to better prospective memory and attentional control performance, whereas cathodal stimulation will have detrimental effects on both functions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'genderBased': True, 'genderDescription': 'Male and female participants will be equally distributed between groups.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No cognitive impairments\n* Fluent in German\n* Right-handed\n* Normal or corrected-to-normal vision\n* Non-smokers\n* Written informed consent\n\nExclusion Criteria:\n\n* Current/lifetime severe psychiatric or neurological disorder\n* Metal implants in the head area\n* Psychotropic medication\n* Dermatosis\n* Current/lifetime alcohol abuse\n* Magnetisable implants'}, 'identificationModule': {'nctId': 'NCT04882527', 'briefTitle': 'Modulating Prospective Memory in Older Adults With Non-invasive Brain Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Bern'}, 'officialTitle': 'Modulating Prospective Memory in Older Adults With Noninvasive Brain Stimulation', 'orgStudyIdInfo': {'id': '2019-01599'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anodal stimulation of the rIFL', 'description': 'Anodal stimulation over the right inferior frontal lobe', 'interventionNames': ['Device: Non-invasive brain stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'cathodal stimulation of the rIFL', 'description': 'Cathodal stimulation over the right inferior frontal lobe', 'interventionNames': ['Device: Non-invasive brain stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'anodal stimulation of the lIFL', 'description': 'Anodal stimulation over the left inferior frontal lobe', 'interventionNames': ['Device: Non-invasive brain stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'cathodal stimulation of the lIFL', 'description': 'Cathodal stimulation over the left inferior frontal lobe', 'interventionNames': ['Device: Non-invasive brain stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'anodal stimulation of the rSPL', 'description': 'Anodal stimulation over the right superior parietal lobe', 'interventionNames': ['Device: Non-invasive brain stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'cathodal stimulation of the rSPL', 'description': 'Cathodal stimulation over the right superior parietal lobe', 'interventionNames': ['Device: Non-invasive brain stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham stimulation', 'description': 'Sham stimulation over either of the three real stimulation areas', 'interventionNames': ['Device: Sham stimulation']}], 'interventions': [{'name': 'Non-invasive brain stimulation', 'type': 'DEVICE', 'otherNames': ['high-definition transcranial direct current stimulation', 'HD-tDCS', 'Soterix medical'], 'description': 'Stimulation will be applied once per subject with one mA for 20 minutes over either the left inferior frontal lobe, the right inferior frontal lobe or the right superior parietal lobe.', 'armGroupLabels': ['anodal stimulation of the lIFL', 'anodal stimulation of the rIFL', 'anodal stimulation of the rSPL', 'cathodal stimulation of the lIFL', 'cathodal stimulation of the rIFL', 'cathodal stimulation of the rSPL']}, {'name': 'Sham stimulation', 'type': 'DEVICE', 'description': 'The electrode positions and the attachment procedures correspond to those of real tDCS but the electrical current will only be ramped up to 1 mA and switched off completely after 30 s of stimulation.', 'armGroupLabels': ['sham stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3008', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Universitätsklinik für Alterspsychiatrie und Psychotherapie', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Stefan Klöppel, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bern'}, {'name': 'Jessica Peter, PD Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Bern'}, {'name': 'Matthias Kliegel, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Geneva'}, {'name': 'Nadine Schmidt, MSc.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}