NCT04882527

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 28, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

2.3 years

First QC Date

May 6, 2021

Last Update Submit

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

EXPERIMENTAL

Anodal stimulation over the right inferior frontal lobe

Device: Non-invasive brain stimulation

cathodal stimulation of the rIFL

EXPERIMENTAL

Cathodal stimulation over the right inferior frontal lobe

Device: Non-invasive brain stimulation

anodal stimulation of the lIFL

EXPERIMENTAL

Anodal stimulation over the left inferior frontal lobe

Device: Non-invasive brain stimulation

cathodal stimulation of the lIFL

EXPERIMENTAL

Cathodal stimulation over the left inferior frontal lobe

Device: Non-invasive brain stimulation

anodal stimulation of the rSPL

EXPERIMENTAL

Anodal stimulation over the right superior parietal lobe

Device: Non-invasive brain stimulation

cathodal stimulation of the rSPL

EXPERIMENTAL

Cathodal stimulation over the right superior parietal lobe

Device: Non-invasive brain stimulation

sham stimulation

SHAM COMPARATOR

Sham stimulation over either of the three real stimulation areas

Device: Sham stimulation

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.

Also known as: high-definition transcranial direct current stimulation, HD-tDCS, Soterix medical
anodal stimulation of the lIFLanodal stimulation of the rIFLanodal stimulation of the rSPLcathodal stimulation of the lIFLcathodal stimulation of the rIFLcathodal stimulation of the rSPL

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.

sham stimulation

Eligibility Criteria

Age60 Years - 80 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale and female participants will be equally distributed between groups.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

Study Officials

  • Stefan Klöppel, Prof. Dr.

    University of Bern

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR

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

Locations