Modulating Prospective Memory in Older Adults With Non-invasive Brain Stimulation
1 other identifier
interventional
106
1 country
1
Brief Summary
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. Previous 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. It 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2021
CompletedFirst Posted
Study publicly available on registry
May 12, 2021
CompletedStudy Start
First participant enrolled
June 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedDecember 12, 2023
December 1, 2023
2.3 years
May 6, 2021
December 11, 2023
Conditions
Outcome Measures
Primary Outcomes (9)
Prospective memory performance
Assessed with a computer task. Number of correct answers given to prospective memory stimuli. Change from baseline to intervention session, difference between intervention groups.
During both sessions (for stimulation session: during intervention), fixed to 14 minutes
Prospective memory reaction time
Assessed with a computer task. Reaction times of answers given to prospective memory stimuli. Change from baseline to intervention session, difference between intervention groups.
During both sessions (for stimulation session: during intervention), fixed to 14 minutes
Executive controlling functioning
Assessed with a computer task (ANT - Attentional Network Task). Interference between answers given to congruent and incongruent stimuli. Change from baseline to intervention session, difference between intervention groups.
During both sessions (for stimulation session: during intervention), task fixed to 6 minutes
Flexibility performance
Assessed with a computer task (TAP- Test of Attentional Performance). Number of correct answers. Change from baseline to intervention session, difference between intervention groups.
During both sessions (for stimulation session: directly after intervention), 3 minutes
Inhibition errors
Assessed with a computer task (Test of Attentional Performance). Sum of incorrect responses to no-go stimuli. Change from baseline to intervention session, difference between intervention groups.
During both sessions (for stimulation session: directly after intervention), 2 minutes
Divided attention misses
Assessed with a computer task (TAP - Test of Attentional Performance). Sum of missed target stimuli. Change from baseline to intervention session, difference between intervention groups.
During both sessions (for stimulation session: directly after intervention), 3 minutes 30 seconds
Flexibility reaction-time
Assessed with a computer task (TAP - Test of Attentional Performance). Mean/ median of reactions times of correct responses. Change from baseline to intervention session, difference between intervention groups.
During both sessions (for stimulation session: directly after intervention), 3 minutes
Inhibition reaction time
Assessed with a go/no-go computer task (TAP -Test of Attentional Performance). Mean/ median of reactions times to correct responses. Change from baseline to intervention session, difference between intervention groups.
During both sessions (for stimulation session: directly after intervention), 2 minutes
Divided attention reaction time
Assessed with a computer-based task (Test of Attentional Performance). Median reaction time of correct answers. Change from baseline to intervention session, difference between intervention groups.
During both sessions (for stimulation session: directly after stimulation), 3 minutes 30 seconds
Secondary Outcomes (5)
Alerting network functioning
During both sessions (for stimulation session: during intervention), task fixed to 6 minutes
Orienting network functioning
During both sessions (for stimulation session: during intervention), task fixed to 6 minutes
Ongoing-task performance
During both sessions (for stimulation session: during intervention), fixed to 14 minutes
Ongoing-task reaction time
During both sessions (for stimulation session: during intervention), fixed to 14 minutes
Ongoing-task intra-individual coefficient of variation
During both sessions (for stimulation session: during intervention), fixed to 14 minutes
Other Outcomes (7)
Self-rated prospective memory
Only at baseline session, after computer-based tasks, 10 minutes
Self-rated metacognitive prospective memory
Only at stimulation session, after intervention, 10 minutes
Stimulation Side-Effects
Only at stimulation session, after intervention, 3 minutes
- +4 more other outcomes
Study Arms (7)
anodal stimulation of the rIFL
EXPERIMENTALAnodal stimulation over the right inferior frontal lobe
cathodal stimulation of the rIFL
EXPERIMENTALCathodal stimulation over the right inferior frontal lobe
anodal stimulation of the lIFL
EXPERIMENTALAnodal stimulation over the left inferior frontal lobe
cathodal stimulation of the lIFL
EXPERIMENTALCathodal stimulation over the left inferior frontal lobe
anodal stimulation of the rSPL
EXPERIMENTALAnodal stimulation over the right superior parietal lobe
cathodal stimulation of the rSPL
EXPERIMENTALCathodal stimulation over the right superior parietal lobe
sham stimulation
SHAM COMPARATORSham stimulation over either of the three real stimulation areas
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- No cognitive impairments
- Fluent in German
- Right-handed
- Normal or corrected-to-normal vision
- Non-smokers
- Written informed consent
You may not qualify if:
- Current/lifetime severe psychiatric or neurological disorder
- Metal implants in the head area
- Psychotropic medication
- Dermatosis
- Current/lifetime alcohol abuse
- Magnetisable implants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinik für Alterspsychiatrie und Psychotherapie
Bern, 3008, Switzerland
Related Publications (1)
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.
PMID: 37549139DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Klöppel, Prof. Dr.
University of Bern
- STUDY CHAIR
Jessica Peter, PD Dr.
University of Bern
- STUDY CHAIR
Matthias Kliegel, Prof. Dr.
University of Geneva
- STUDY CHAIR
Nadine Schmidt, MSc.
University of Bern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2021
First Posted
May 12, 2021
Study Start
June 28, 2021
Primary Completion
October 31, 2023
Study Completion
October 31, 2023
Last Updated
December 12, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share