Healthy Older Adults Clinical Trial
— TRAINSTIM2Official title:
Effects of Transcranial Direct Current Stimulation (tDCS) on Associative Learning in Older Adults
NCT number | NCT02839993 |
Other study ID # | TRAINSTIM2.A |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2016 |
Est. completion date | May 1, 2018 |
Verified date | May 2021 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | May 1, 2018 |
Est. primary completion date | March 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 66 Years and older |
Eligibility | Inclusion Criteria: - Age: old-retired (=66 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) |
Country | Name | City | State |
---|---|---|---|
Germany | Charité Universitätsmedizin Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Performance in a verbal associative learning paradigm under anodal tDCS compared to sham tDCS. | Investigation whether anodal tDCS leads to improved performance accuracy in the Wernicko task compared to sham stimulation. | Performance is assessed within 1 day 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 outcomes: Attention performance | Digit span forward performance assessed before and after stimulation to test for tDCS effects on attention | Performance is assessed within 1 day before and after tDCS + training compared to sham | |
Secondary | Other cognitive outcomes: working memory | Digit span backwards performance assessed before and after stimulation to test for tDCS effects on working memory | Performance is assessed within 1 day before and after tDCS + training compared to sham |
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