NCT04633499

Brief Summary

The aim of the study is to explore the effect of transcranial direct current stimulation (tDCS) on either the right tempo-parietal junction (rTPJ) or the dorsomedial prefrontal cortex (dmPFC) in healthy older adults (replication in a different sample of a study by Martin et al., 2020).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

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

Study Start

First participant enrolled

August 1, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

June 2, 2022

Status Verified

June 1, 2022

Enrollment Period

1.8 years

First QC Date

August 27, 2020

Last Update Submit

June 1, 2022

Conditions

Keywords

tDCSSocial Cognition

Outcome Measures

Primary Outcomes (4)

  • Response Time in milliseconds in Visual-Perspective Taking Paradigm (VPT) in the active tDCS.

    The outcome in the VPT paradigm will be response time in milliseconds (for correct answers only).

    at Day 1 or 7 (depends on randomization)

  • Response Time in milliseconds in Visual-Perspective Taking Paradigm (VPT) in the sham tDCS.

    The outcome in the VPT paradigm will be response time in milliseconds (for correct answers only).

    at Day 1 or 7 (depends on randomization)

  • Response Time in milliseconds in the Reading the mind in the eyes test (RMET) in the active tDCS.

    Outcome in the RMET will be reaction times in milliseconds (of correct answers only) in either rTPJ or dmPFC stimulation in comparison to sham stimulation.

    at Day 1 or 7 (depends on randomization)

  • Response Time in milliseconds in the Reading the mind in the eyes test (RMET) in the sham tDCS.

    Outcome in the RMET will be reaction times in milliseconds (of correct answers only) in either rTPJ or dmPFC stimulation in comparison to sham stimulation.

    at Day 1 or 7 (depends on randomization)

Secondary Outcomes (1)

  • Functional and structural connectivity (via MRI)

    MRI Assessment takes places before participants are stimulated with tDCS at Baseline (Day 1).

Study Arms (3)

dmPFC tDCS + Social Cognition tasks in older participants

ACTIVE COMPARATOR

Participants will receive either active or sham stimulation over the dmPFC while conducting two different social cognition paradigms: one regarding emotion recognition, one on visual perspective taking.

Behavioral: Social Cognition TaskDevice: tDCS

rTPJ tDCS + Social Cognition tasks in older participants

EXPERIMENTAL

Participants will receive either active or sham stimulation over the rTPJ while conducting two different social cognition paradigms: one regarding emotion recognition, one on visual perspective taking.

Behavioral: Social Cognition TaskDevice: tDCS

Social cognition tasks in younger participants

ACTIVE COMPARATOR

Participants will conduct two different social cognition paradigms: one regarding emotion recognition, one on visual perspective taking but without tDCS stimulation.

Behavioral: Social Cognition Task

Interventions

Two paradigms will be tested: visual perspective taking and reading the mind in the eyes.

Social cognition tasks in younger participantsdmPFC tDCS + Social Cognition tasks in older participantsrTPJ tDCS + Social Cognition tasks in older participants
tDCSDEVICE

tDCS either over the dmPFC or the rTPJ.

dmPFC tDCS + Social Cognition tasks in older participantsrTPJ tDCS + Social Cognition tasks in older participants

Eligibility Criteria

Age18 Years - 80 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsParticipants were asked to name the gender with which they identify.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy older (60 - 80 years) and younger (18 - 30 years) participants
  • German as their main language or sufficient german skills to understand the experiment and the task

You may not qualify if:

  • participants with neuropsychological or psychiatric disease that affect cognition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medicine Greifswald

Greifswald, 17489, Germany

Location

Related Publications (2)

  • Martin AK, Kessler K, Cooke S, Huang J, Meinzer M. The Right Temporoparietal Junction Is Causally Associated with Embodied Perspective-taking. J Neurosci. 2020 Apr 8;40(15):3089-3095. doi: 10.1523/JNEUROSCI.2637-19.2020. Epub 2020 Mar 4.

    PMID: 32132264BACKGROUND
  • Roheger M, Mader A, Riemann S, Niemann F, Kessler K, Martin AK, Meinzer M. Intact embodiment during perspective-taking in older adults is not affected by focal tDCS. Geroscience. 2025 Dec;47(6):6823-6837. doi: 10.1007/s11357-025-01554-4. Epub 2025 Feb 19.

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Marcus Meinzer, Dr.

    Universitymedicine Greifswald

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants will receive either an active or a sham tDCS stimulation. Sham stimulation will use a ramp-up, so that participants are not able to tell whether they are stimulated or not, if they are tDCS naive. Sham or active tDCS is applied via codes. Principal Investigators are blinded for these codes.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: It is a randomized, balanced cross-over design with within- as well as between group comparisons. Two groups will be investigate: young participants (n = 30) and older participants (n = 60). The group of young participants will serve as a control group and will only get a neuropsychological assessment of their cognitive abilities at the beginning of the study, an MRI assessment and one session of the investigated paradigms (without tDCS). The group of older participants will conduct a session of MRI assessment and neuropsychological assessment, as well as two tDCS sessions (anodal/sham). The stimulation will either be over the rTPJ or the dmPFC. This set-up is identical to the study of Martin et al., (2020).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2020

First Posted

November 18, 2020

Study Start

August 1, 2020

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

June 2, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations