Healthy AgingNCT04882527
Modulating Prospective Memory in Older Adults With Non-invasive Brain Stimulation
A study testing Non-invasive brain stimulation in people with Healthy Aging, run by University of Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Non-invasive brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Jun 2021to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No cognitive impairments
- Fluent in German
- Right-handed
- Normal or corrected-to-normal vision
- Non-smokers
- Written informed consent
Who cannot join
- Current/lifetime severe psychiatric or neurological disorder
- Metal implants in the head area
- Psychotropic medication
- Dermatosis
- Current/lifetime alcohol abuse
- Magnetisable implants
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitätsklinik für Alterspsychiatrie und Psychotherapie
Bern, 3008
About this study
Official title: Modulating Prospective Memory in Older Adults With Noninvasive Brain Stimulation
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.
Read the detailed description
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.
A 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.
The 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.
It 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.
- Conditions
- Healthy Aging
- Being tested
- Non-invasive brain stimulation, Sham stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive brain stimulationDevice
Also called high-definition transcranial direct current stimulation, HD-tDCS, Soterix medical
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.
Sham stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| anodal stimulation of the rIFL | Experimental | Anodal stimulation over the right inferior frontal lobe Receives: Device: Non-invasive brain stimulation |
| cathodal stimulation of the rIFL | Experimental | Cathodal stimulation over the right inferior frontal lobe Receives: Device: Non-invasive brain stimulation |
| anodal stimulation of the lIFL | Experimental | Anodal stimulation over the left inferior frontal lobe Receives: Device: Non-invasive brain stimulation |
| cathodal stimulation of the lIFL | Experimental | Cathodal stimulation over the left inferior frontal lobe Receives: Device: Non-invasive brain stimulation |
| anodal stimulation of the rSPL | Experimental | Anodal stimulation over the right superior parietal lobe Receives: Device: Non-invasive brain stimulation |
| cathodal stimulation of the rSPL | Experimental | Cathodal stimulation over the right superior parietal lobe Receives: Device: Non-invasive brain stimulation |
| sham stimulation | Sham comparator | Sham stimulation over either of the three real stimulation areas Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During both sessions (for stimulation session: directly after stimulation), 3 minutes 30 seconds
Secondary outcomes (5)
Alerting network functioning
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.
Change from baseline to intervention session, difference between intervention groups.
Measured: During both sessions (for stimulation session: during intervention), task fixed to 6 minutes
Orienting network functioning
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.
Change from baseline to intervention session, difference between intervention groups.
Measured: During both sessions (for stimulation session: during intervention), task fixed to 6 minutes
Ongoing-task performance
Assessed with a computer task. Number of correctly answered ongoing task stimuli in the course of the prospective memory task.
Change from baseline to intervention session, difference between intervention groups.
Measured: During both sessions (for stimulation session: during intervention), fixed to 14 minutes
Ongoing-task reaction time
Assessed with a computer task. Mean/median response time of correct ongoing task answers in the course of the prospective memory task.
Change from baseline to intervention session, difference between intervention groups.
Measured: During both sessions (for stimulation session: during intervention), fixed to 14 minutes
Ongoing-task intra-individual coefficient of variation
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.
Change from baseline to intervention session, difference between intervention groups.
Measured: During both sessions (for stimulation session: during intervention), fixed to 14 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start28 Jun 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Klöppel, Prof. Dr., Principal investigator, University of BernJessica Peter, PD Dr., Study chair, University of BernMatthias Kliegel, Prof. Dr., Study chair, University of Geneva, SwitzerlandNadine Schmidt, MSc., Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882527
- Sponsor's protocol ID
- 2019-01599
- Other IDs
- 2019
- Status last verified
- Dec 2023
- First submitted
- 6 May 2021
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37549139
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Prospective Memory in Older Adults With Noninvasive Brain Stimulation
- ClinicalTrials.gov ID
- NCT04882527
- Acronym / sponsor ID
- 2019-01599
- Conditions
- Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
A 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.
The 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.
It 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| anodal stimulation of the rIFL | Experimental | Device: Non-invasive brain stimulationAnodal stimulation over the right inferior frontal lobe |
| cathodal stimulation of the rIFL | Experimental | Device: Non-invasive brain stimulationCathodal stimulation over the right inferior frontal lobe |
| anodal stimulation of the lIFL | Experimental | Device: Non-invasive brain stimulationAnodal stimulation over the left inferior frontal lobe |
| cathodal stimulation of the lIFL | Experimental | Device: Non-invasive brain stimulationCathodal stimulation over the left inferior frontal lobe |
| anodal stimulation of the rSPL | Experimental | Device: Non-invasive brain stimulationAnodal stimulation over the right superior parietal lobe |
| cathodal stimulation of the rSPL | Experimental | Device: Non-invasive brain stimulationCathodal stimulation over the right superior parietal lobe |
| sham stimulation | Sham comparator | Device: Sham stimulationSham stimulation over either of the three real stimulation areas |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- No cognitive impairments
- Fluent in German
- Right-handed
- Normal or corrected-to-normal vision
- Non-smokers
Key exclusion criteria (6 listed)
- Current/lifetime severe psychiatric or neurological disorder
- Metal implants in the head area
- Psychotropic medication
- Dermatosis
- Current/lifetime alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive brain stimulationAlso: high-definition transcranial direct current stimulation, HD-tDCS, Soterix medicalStimulation 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. | Device | 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 |
| Sham stimulationThe 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. | Device | sham stimulation |
Primary outcome
Prospective memory performance
Time frame: During both sessions (for stimulation session: during intervention), fixed to 14 minutes
Assessed with a computer task. Number of correct answers given to prospective memory stimuli. Change from baseline to intervention session, difference between intervention groups.
Prospective memory reaction time
Time frame: During both sessions (for stimulation session: during intervention), fixed to 14 minutes
Assessed with a computer task. Reaction times of answers given to prospective memory stimuli. Change from baseline to intervention session, difference between intervention groups.
Executive controlling functioning
Time frame: During both sessions (for stimulation session: during intervention), task fixed to 6 minutes
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.
Flexibility performance
Time frame: During both sessions (for stimulation session: directly after intervention), 3 minutes
Assessed with a computer task (TAP- Test of Attentional Performance). Number of correct answers. Change from baseline to intervention session, difference between intervention groups.
Inhibition errors
Time frame: During both sessions (for stimulation session: directly after intervention), 2 minutes
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.
Divided attention misses
Time frame: During both sessions (for stimulation session: directly after intervention), 3 minutes 30 seconds
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.
Flexibility reaction-time
Time frame: During both sessions (for stimulation session: directly after intervention), 3 minutes
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.
Inhibition reaction time
Time frame: During both sessions (for stimulation session: directly after intervention), 2 minutes
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.
Divided attention reaction time
Time frame: During both sessions (for stimulation session: directly after stimulation), 3 minutes 30 seconds
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.
5 secondary outcomes
Alerting network functioning
Time frame: During both sessions (for stimulation session: during intervention), task fixed to 6 minutes
Orienting network functioning
Time frame: During both sessions (for stimulation session: during intervention), task fixed to 6 minutes
Ongoing-task performance
Time frame: During both sessions (for stimulation session: during intervention), fixed to 14 minutes
Ongoing-task reaction time
Time frame: During both sessions (for stimulation session: during intervention), fixed to 14 minutes
Ongoing-task intra-individual coefficient of variation
Time frame: During both sessions (for stimulation session: during intervention), fixed to 14 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Derived from this study: PubMed 37549139Schmidt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Klöppel, Prof. Dr. principal investigator
University of Bern
Jessica Peter, PD Dr. study chair
University of Bern
Matthias Kliegel, Prof. Dr. study chair
University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive brain stimulation in people with Healthy Aging, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospective memory performance (time frame: During both sessions (for stimulation session: during intervention), fixed to 14 minutes). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04882527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.