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Modulating Prospective Memory in Older Adults With Non-invasive Brain Stimulation

NCT ID: NCT04882527

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-28

Study Completion Date

2023-10-31

Brief Summary

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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

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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

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Healthy Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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anodal stimulation of the rIFL

Anodal stimulation over the right inferior frontal lobe

Group Type EXPERIMENTAL

Non-invasive brain stimulation

Intervention Type DEVICE

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.

cathodal stimulation of the rIFL

Cathodal stimulation over the right inferior frontal lobe

Group Type EXPERIMENTAL

Non-invasive brain stimulation

Intervention Type DEVICE

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.

anodal stimulation of the lIFL

Anodal stimulation over the left inferior frontal lobe

Group Type EXPERIMENTAL

Non-invasive brain stimulation

Intervention Type DEVICE

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.

cathodal stimulation of the lIFL

Cathodal stimulation over the left inferior frontal lobe

Group Type EXPERIMENTAL

Non-invasive brain stimulation

Intervention Type DEVICE

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.

anodal stimulation of the rSPL

Anodal stimulation over the right superior parietal lobe

Group Type EXPERIMENTAL

Non-invasive brain stimulation

Intervention Type DEVICE

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.

cathodal stimulation of the rSPL

Cathodal stimulation over the right superior parietal lobe

Group Type EXPERIMENTAL

Non-invasive brain stimulation

Intervention Type DEVICE

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 stimulation

Sham stimulation over either of the three real stimulation areas

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type DEVICE

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.

Interventions

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Non-invasive brain stimulation

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.

Intervention Type DEVICE

Sham stimulation

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.

Intervention Type DEVICE

Other Intervention Names

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high-definition transcranial direct current stimulation HD-tDCS Soterix medical

Eligibility Criteria

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Inclusion Criteria

* No cognitive impairments
* Fluent in German
* Right-handed
* Normal or corrected-to-normal vision
* Non-smokers
* Written informed consent

Exclusion Criteria

* Current/lifetime severe psychiatric or neurological disorder
* Metal implants in the head area
* Psychotropic medication
* Dermatosis
* Current/lifetime alcohol abuse
* Magnetisable implants
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Klöppel, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Jessica Peter, PD Dr.

Role: STUDY_CHAIR

University of Bern

Matthias Kliegel, Prof. Dr.

Role: STUDY_CHAIR

University of Geneva

Nadine Schmidt, MSc.

Role: STUDY_CHAIR

University of Bern

Locations

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Universitätsklinik für Alterspsychiatrie und Psychotherapie

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 37549139 (View on PubMed)

Other Identifiers

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2019-01599

Identifier Type: -

Identifier Source: org_study_id