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Modulation of Visual-Spatial Learning in Healthy Older Adults by tDCS

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ClinicalTrials.gov Identifier: NCT02110056
Recruitment Status : Completed
First Posted : April 10, 2014
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Older Adults Device: tDCS Behavioral: training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Modulation of Visual-Spatial Learning in Healthy Older Adults by Transcranial Direct Current Stimulation - Proof of Principle and Mechanisms
Study Start Date : March 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Experimental: training + tDCS
Combination of intensive training of visual-spatial abilities (LOCATO task) with transcranial direct current stimulation (tDCS)
Device: tDCS
transcranial direct current stimulation (tDCS)

Behavioral: training
intensive training of visual-spatial abilities (in LOCATO task)

Sham Comparator: training + sham stimulation
Combination of intensive training of visual-spatial abilities (LOCATO task) with sham stimulation
Device: tDCS
transcranial direct current stimulation (tDCS)

Behavioral: training
intensive training of visual-spatial abilities (in LOCATO task)




Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. long term effects [ Time Frame: after 1 month vs baseline ]
    long term effects measured by performance in LOCATO task after end of training and after 1 month compared to control condition

  2. functional changes: Connectivity [ Time Frame: after end of 3-day period of training vs baseline ]
    Connectivity (measured by resting-state fMRT and correlation analysis) at baseline compared to end of 3 day period of training

  3. cortical excitability [ Time Frame: at baseline ]
    measured by transcranial magnetic stimulation (TMS) at baseline

  4. 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)

  5. 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

  6. 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

  7. 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).



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110056


Locations
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Germany
Charite Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Agnes Flöel, Prof. Dr. Charite University, Berlin, Germany

Publications of Results:
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Responsible Party: Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02110056     History of Changes
Other Study ID Numbers: LOCATO-OA-tDCS
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

Keywords provided by Agnes Flöel, Charite University, Berlin, Germany:
healthy older adults
tDCS
LOCATO task
visual-spatial learning