- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02110056
Modulation of Visual-Spatial Learning in Healthy Older Adults by tDCS
January 29, 2018 updated by: Agnes Flöel, Charite University, Berlin, Germany
Modulation of Visual-Spatial Learning in Healthy Older Adults by Transcranial Direct Current Stimulation - Proof of Principle and Mechanisms
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Berlin, Germany, 10117
- Charité Universitätsmedizin Berlin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: training + sham stimulation
Combination of intensive training of visual-spatial abilities (LOCATO task) with sham stimulation
|
transcranial direct current stimulation (tDCS)
intensive training of visual-spatial abilities (in LOCATO task)
|
|
Experimental: training + tDCS
Combination of intensive training of visual-spatial abilities (LOCATO task) with transcranial direct current stimulation (tDCS)
|
transcranial direct current stimulation (tDCS)
intensive training of visual-spatial abilities (in LOCATO task)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance in LOCATO task (Visual-Spatial learning and memory) after a combination of intensive visual-spatial training and tDCS
Time Frame: immediately after the end of a 3 day training period in tDCS condition compared to sham condition
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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.
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immediately after the end of a 3 day training period in tDCS condition compared to sham condition
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
memory
Time Frame: immediately after end of 3-day of cognitive training, after 1 month vs. baseline
|
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
|
|
affective state
Time Frame: immediately after the end of 3-day cognitive training, after 1 month vs. baseline
|
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
|
|
genotyping of learning related polymorphisms
Time Frame: once
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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
|
|
long term effects
Time Frame: after 1 month vs baseline
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long term effects measured by performance in LOCATO task after end of training and after 1 month compared to control condition
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after 1 month vs baseline
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functional changes: Connectivity
Time Frame: after end of 3-day period of training vs baseline
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Connectivity (measured by resting-state fMRT and correlation analysis) at baseline compared to end of 3 day period of training
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after end of 3-day period of training vs baseline
|
|
cortical excitability
Time Frame: at baseline
|
measured by transcranial magnetic stimulation (TMS) at baseline
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at baseline
|
|
Quality of life
Time Frame: after 1 month vs baseline
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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)
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after 1 month vs baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Antonenko D, Kulzow N, Cesarz ME, Schindler K, Grittner U, Floel 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 2016.
- Antonenko D, Kulzow N, Sousa A, Prehn K, Grittner U, Floel 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
February 13, 2014
First Submitted That Met QC Criteria
April 8, 2014
First Posted (Estimate)
April 10, 2014
Study Record Updates
Last Update Posted (Actual)
January 30, 2018
Last Update Submitted That Met QC Criteria
January 29, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- LOCATO-OA-tDCS
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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