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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02110056
Other study ID # LOCATO-OA-tDCS
Secondary ID
Status Completed
Phase N/A
First received February 13, 2014
Last updated January 29, 2018
Start date March 2014
Est. completion date November 2015

Study information

Verified date January 2018
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 combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement of learning and memory in healthy older adults and to examine the underlying neuronal mechanism.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 90 Years
Eligibility Inclusion Criteria (old healthy controls):

- right handedness

- unobtrusive neuropsychological screening

- age: 50-90 years

Exclusion Criteria:

- severe internal or psychiatric disease

- epilepsy

- other severe neurological diseases, e.g. previous major stroke or brain tumor

- DMS-IV manifest dementia

- contraindication for MRT (claustrophobia, metallic implants, tattoos)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
tDCS
transcranial direct current stimulation (tDCS)
Behavioral:
training
intensive training of visual-spatial abilities (in LOCATO task)

Locations

Country Name City State
Germany Charite Universitätsmedizin Berlin Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Antonenko D, Külzow N, Cesarz ME, Schindler K, Grittner U, Flöel A. Hippocampal Pathway Plasticity Is Associated with the Ability to Form Novel Memories in Older Adults. Front Aging Neurosci. 2016 Mar 22;8:61. doi: 10.3389/fnagi.2016.00061. eCollection 20 — View Citation

Antonenko D, Külzow N, Sousa A, Prehn K, Grittner U, Flöel A. Neuronal and behavioral effects of multi-day brain stimulation and memory training. Neurobiol Aging. 2018 Jan;61:245-254. doi: 10.1016/j.neurobiolaging.2017.09.017. Epub 2017 Sep 28. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Performance in LOCATO task (Visual-Spatial learning and memory) after a combination of intensive visual-spatial training and tDCS Investigation whether the combination of intensive visual-spatial training (LOCATO task) and tDCS leads to an improvement of visual-spatial learning and memory measured by performance in LOCATO task after end of a 3 day training period compared to sham stimulation. immediately after the end of a 3 day training period in tDCS condition compared to sham condition
Secondary long term effects long term effects measured by performance in LOCATO task after end of training and after 1 month compared to control condition after 1 month vs baseline
Secondary functional changes: Connectivity Connectivity (measured by resting-state fMRT and correlation analysis) at baseline compared to end of 3 day period of training after end of 3-day period of training vs baseline
Secondary cortical excitability measured by transcranial magnetic stimulation (TMS) at baseline at baseline
Secondary Quality of life quality of life as measured by standardized questionaire at baseline compared to quality of life measured 1 month after intervention (training and stimulation vs. training and sham-stimualtion) after 1 month vs baseline
Secondary memory memory performance tested at baseline compared to memory performance after the end of a 3-day cognitive training period and after 1 month (posttraining) in training and stimulation vs. training and sham stimulation immediately after end of 3-day of cognitive training, after 1 month vs. baseline
Secondary affective state affective state measured at baseline compared to affective state measured after the end of a 3-day cognitve training period and after 1 month (posttraining) in training and stimulation vs. training and sham stimulation immediately after the end of 3-day cognitive training, after 1 month vs. baseline
Secondary genotyping of learning related polymorphisms To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed (i.e., APOE, BDNF Val66Met, COMT Val158Met). once
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