- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04633499
Effects of tDCS on Social Cognition in Aging (SoCoStim)
Effects of tDCS on Visual Perspective Taking and Emotion Recognition in Healthy Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Humans are fundamentally social animals. The ability to operate within large social networks requires considerable cognitive capacity, often referred to as social cognition. One social cognitive process thought to involve embodied and nonembodied processes is perspective-taking. Recently, the right temporoparietal junction (rTPJ) has been suggested as a key hub for embodied processing relevant to social cognition. A study of Martin et al. (2020) could further provide causal evidence that the right temporoparietal junction is involved specifically in the embodied component of perspective-taking. Specifically, HD-tDCS (high-definition transcranial direct current stimulation) to the right temporoparietal junction, but not another hub of the social brain (dorsomedial PFC), increased the effect of body position during perspective-taking, but not tracking. As social cognition is affected by the aging process and decline of socio-cognitive abilities is a key feature of neurological diseases such as Alzheimer's or Parkinson's disease, the aim of the present study is to replicate the findings of Martin et al., (2020) in a sample of healthy older adults to better understand the modulation of socio-cognitive processes in older age.
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). 60 healthy older adults and 30 younger participants (serving as a control group) will be tested in a Reading the Eyes in the Mind Task (RMET) and a Task of Visual Perspective Taking (VPT) , while stimulation either the rTPJ or the dmPFC with either active or sham tDCS (stimulation only in the group of older participants). In the RMET the expectation is that older participants have higher reaction times after correct answers under rTPJ tDCS. No stimulation effects of the dmPFC are expected. In the VPT older participants are expected to have a selective effect on body position (similar to the results of Martin et al., 2020) under rTPJ stimulation, but not dmPFC stimulation.
A further focus of the study is how functional and structural connectivity of the brain and individual differences measured with an MRI assessment influence with the success of the RMET and VPT paradigms in an explorative research question.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Greifswald, Germany, 17489
- University Medicine Greifswald
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- participants with neuropsychological or psychiatric disease that affect cognition.
- standard MRI exclusion criteria (e.g. pregnancy, metal implants)
- standard tDCS exclusion criteria (e.g. metal implants in the head)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: dmPFC tDCS + Social Cognition tasks in older participants
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.
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Two paradigms will be tested: visual perspective taking and reading the mind in the eyes.
tDCS either over the dmPFC or the rTPJ.
|
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Experimental: rTPJ tDCS + Social Cognition tasks in older participants
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.
|
Two paradigms will be tested: visual perspective taking and reading the mind in the eyes.
tDCS either over the dmPFC or the rTPJ.
|
|
Active Comparator: Social cognition tasks in younger participants
Participants will conduct two different social cognition paradigms: one regarding emotion recognition, one on visual perspective taking but without tDCS stimulation.
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Two paradigms will be tested: visual perspective taking and reading the mind in the eyes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Response Time in milliseconds in Visual-Perspective Taking Paradigm (VPT) in the active tDCS.
Time Frame: at Day 1 or 7 (depends on randomization)
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The outcome in the VPT paradigm will be response time in milliseconds (for correct answers only).
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at Day 1 or 7 (depends on randomization)
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Response Time in milliseconds in Visual-Perspective Taking Paradigm (VPT) in the sham tDCS.
Time Frame: at Day 1 or 7 (depends on randomization)
|
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.
Time Frame: at Day 1 or 7 (depends on randomization)
|
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.
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at Day 1 or 7 (depends on randomization)
|
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Response Time in milliseconds in the Reading the mind in the eyes test (RMET) in the sham tDCS.
Time Frame: at Day 1 or 7 (depends on randomization)
|
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.
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at Day 1 or 7 (depends on randomization)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional and structural connectivity (via MRI)
Time Frame: MRI Assessment takes places before participants are stimulated with tDCS at Baseline (Day 1).
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It will be investigated how functional and structural connectivity of the brain and individual differences measured with an MRI assessment influence with the success of the RMET and VPT paradigms in an explorative research question.Structural and functional connectivity will be assessed.
|
MRI Assessment takes places before participants are stimulated with tDCS at Baseline (Day 1).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marcus Meinzer, Dr., Universitymedicine Greifswald
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SoCoStim
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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