- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02110407
Modulation of Visual-Spatial Learning in Healthy Young Adults by tDCS
July 26, 2017 updated by: Agnes Flöel, Charite University, Berlin, Germany
Modulation of Visual-Spatial Learning in Healthy Young 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 young adults and to examine the underlying neuronal mechanism.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
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
-
-
-
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
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- right handednesss
- unobtrusive neuropsychological screening
- age: 18-35 years
Exclusion Criteria:
- severe internal or psychiatric disease
- epilepsy
- other severe neurological disease, e.g. previous major stroke, 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 end of a 3 day period of training in tDCS condition vs sham condition
|
Investigation whether the combination of intensive visual-spatial training (LOCATO task) and tDCS leads to improvement of visual-spatial learning and memory measured by the performance in LOCATO task after end of a 3 day period of training compared to sham stimulation.
|
immediately after end of a 3 day period of training in tDCS condition vs sham condition
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cortical excitability
Time Frame: at baseline
|
cortical excitability measured by transcranial magnetic stimulation (TMS)
|
at baseline
|
|
Quality of Life
Time Frame: after 1 month vs baseline
|
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
|
|
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
|
|
genotyping of learning related polymorphisms
Time Frame: once
|
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
|
long term effetcs measured by performance in LOCATO task after end of training and after 1 month compared to control conditions
|
after 1 month vs baseline
|
|
functional changes: Connectivity
Time Frame: after end of 3-day cognitive training vs baseline
|
Connectivity (measured by resting-state fMRT and correlation analysis) at baseline compared to end of training
|
after end of 3-day cognitive training vs baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
March 1, 2014
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
May 1, 2017
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)
July 27, 2017
Last Update Submitted That Met QC Criteria
July 26, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- LOCATO-YA-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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