- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03094520
Cognitive Embodiment Activation by tDCS (GEST)
Effects of Transcranial Direct Current Stimulation (tDCS) on Gestural-verbal Brain Associations: the Role of Cognitive Embodiment
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Berlin, Germany, 10117
- Charité
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Right handedness
- unobtrusive neuropsychological screening
Exclusion Criteria:
- History of severe alcoholism or use of drugs.
- Severe psychiatric disorders such as depression, psychosis (if not in remission) and severe untreated medical problems.
- Contraindication for MRT (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anodal tDCS + semantic, motor, attentional tasks
Combination of gestural (subjects have to indicate if the gesture is related to the word), attentional and motor tasks with anodal stimulation
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Transcranial direct current stimulation (tDCS)
Other Names:
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Sham Comparator: Sham tDCS + semantic, motor, attentional tasks
Combination of gestural (subjects have to indicate if the gesture is related to the word), attentional and motor tasks with sham stimulation
|
sham stimulation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
response time in semantic decision task
Time Frame: assessed during stimulation or sham stimulation of semantic decision task (last approximately 10 min) at specific timepoint within 2 weeks
|
Comparing response time in semantic decision task under anodal tDCS compared to sham stimulation (change from sham stimulation)
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assessed during stimulation or sham stimulation of semantic decision task (last approximately 10 min) at specific timepoint within 2 weeks
|
performance in attentional load task
Time Frame: assessed during stimulation or sham stimulation of attentional load task (last approximately 6 min) at specific timepoint within 2 weeks
|
Attentional load task: Participants are presented with a 6 positions ring that includes different shapes, they have to press V when they see a square and N when they see a diamond. They will have to ignore any shapes other than square and diamond within the ring or distractors that appear outside the ring. Comparing performance in attentional load task under anodal tDCS compared to sham stimulation (change from sham stimulation) |
assessed during stimulation or sham stimulation of attentional load task (last approximately 6 min) at specific timepoint within 2 weeks
|
performance in motor task
Time Frame: assessed during stimulation or sham stimulation of motor task (last approximately 4 min) at specific timepoint within 2 weeks
|
Motor Task: Participants are presented with a red Box and they have to click a button each time they see it as fast as they can. Comparing performance in motor task under anodal tDCS compared to sham stimulation (change from sham stimulation) |
assessed during stimulation or sham stimulation of motor task (last approximately 4 min) at specific timepoint within 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional connectivity predictors
Time Frame: assessed during baseline testing
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Connectivity as measured by resting-state fMRI during baseline as predictors for performance and tDCS responsiveness
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assessed during baseline testing
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Other cognitive outcomes: change in working memory performance
Time Frame: change in working memory performance from baseline after 30 min (approximately)
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Digit span backward performance assessed before (baseline) and after stimulation to test for tDCS effects on working memory
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change in working memory performance from baseline after 30 min (approximately)
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Other cognitive outcomes: change in Attention performance
Time Frame: change in attention performance from baseline after 30 min (approximately)
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Digit span forward performance assessed before baseline) and after stimulation to test for tDCS effects on attention
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change in attention performance from baseline after 30 min (approximately)
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Collaborators and Investigators
Investigators
- Principal Investigator: Agnes Floeel, Prof, Charité Universitätsmedizin
Publications and helpful links
General Publications
- Floel A, Rosser N, Michka O, Knecht S, Breitenstein C. Noninvasive brain stimulation improves language learning. J Cogn Neurosci. 2008 Aug;20(8):1415-22. doi: 10.1162/jocn.2008.20098.
- Cohen-Maximov T, Avirame K, Floel A, Lavidor M. Modulation of Gestural-verbal Semantic Integration by tDCS. Brain Stimul. 2015 May-Jun;8(3):493-8. doi: 10.1016/j.brs.2014.12.001. Epub 2014 Dec 11.
- Floel A, Ellger T, Breitenstein C, Knecht S. Language perception activates the hand motor cortex: implications for motor theories of speech perception. Eur J Neurosci. 2003 Aug;18(3):704-8. doi: 10.1046/j.1460-9568.2003.02774.x.
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
Other Study ID Numbers
- GEST
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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