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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02795702
Other study ID # TRAINSTIM2.B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2017
Est. completion date May 1, 2018

Study information

Verified date May 2021
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual associative memory leads to a performance improvement in healthy older individuals.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date May 1, 2018
Est. primary completion date March 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 65 Years
Eligibility Inclusion Criteria: - Age: older in working age (50-65 years) - Right handedness - unobtrusive neuropsychological screening Exclusion Criteria: - Mild cognitive impairment (MCI) or other neurological diseases. - 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 MRI (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women).

Study Design


Related Conditions & MeSH terms


Intervention

Device:
tDCS
Transcranial direct current stimulation
Behavioral:
training
Cognitive training

Locations

Country Name City State
Germany Charité Universitätsmedizin Berlin Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Breitenstein C, Jansen A, Deppe M, Foerster AF, Sommer J, Wolbers T, Knecht S. Hippocampus activity differentiates good from poor learners of a novel lexicon. Neuroimage. 2005 Apr 15;25(3):958-68. — View Citation

Breitenstein C, Knecht S. Development and validation of a language learning model for behavioral and functional-imaging studies. J Neurosci Methods. 2002 Mar 15;114(2):173-9. — View Citation

Flöel A, Rösser 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Performance in a verbal associative learning paradigm under anodal tDCS compared to sham Investigation whether anodal tDCS leads to improved performance accuracy in the Wernicko task compared to sham stimulation. assessed immediately after training period (several learning blocks) compared to sham
Secondary Functional connectivity predictors Connectivity as measured by resting-state fMRI during baseline as predictors for performance and tDCS responsiveness assessed during baseline testing
Secondary Structural predictors Microstructure of white matter (Fractional Anisotropy) as measured by diffusion tensor imaging during baseline as predictors for performance and tDCS responsiveness assessed during baseline testing
Secondary Genotyping of learning related polymorphisms To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed : assessed during baseline screening
Secondary Other cognitive outcome: Attention Digit span forward performance assessed before and after stimulation to test for tDCS effects on attention assessed directly before and immediately after tDCS + training compared to
Secondary Other cognitive outcome: Working memory Digit span backwards performance assessed before and after stimulation to test for tDCS effects on working memory assessed directly before and immediately after tDCS + training compared to
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