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Investigating Accelerated Learning in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055884
Recruitment Status : Suspended (low numbers of participants)
First Posted : February 16, 2017
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Sven Vanneste, The University of Texas at Dallas

Tracking Information
First Submitted Date  ICMJE February 14, 2017
First Posted Date  ICMJE February 16, 2017
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE February 13, 2017
Actual Primary Completion Date April 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
Associative Memory assessed by a Verbal Paired-Associate memory test [ Time Frame: baseline and 1 week after the tDCS ]
Changes in performance in the Verbal Paired-Associate memory task is compared between the 4 groups (1. tDCS+verbal paired-associate learning task with repeated retrieval practice, 2. tDCS + verbal paired-associate learning task without repeated retrieval practice, 3. Sham tDCS+verbal paired-associate learning task with repeated retrieval practice, 4. Sham tDCS + verbal paired-associate learning task without repeated retrieval practice) to investigate the influence of tDCS and learning method on Associative Memory
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
Associative Memory assessed by a Verbal Paired-Associate test [ Time Frame: baseline and 1 week after the tDCS ]
Changes in performance in the Verbal Paired-Associate memory task is compared between the 4 groups (1. tDCS+verbal paired-associate learning task with repeated retrieval practice, 2. tDCS + verbal paired-associate learning task without repeated retrieval practice, 3. Sham tDCS+verbal paired-associate learning task with repeated retrieval practice, 4. Sham tDCS + verbal paired-associate learning task without repeated retrieval practice) to investigate the influence of tDCS and learning method on Associative Memory
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigating Accelerated Learning in Healthy Subjects
Official Title  ICMJE Investigating Accelerated Learning in Healthy Subjects
Brief Summary The purpose of this study is to investigate whether it is possible to accelerate learning and improve associative memory performance in healthy subjects, by (1) applying transcranial Direct Current Stimulation (tDCS) during a verbal paired-associate learning task and by (2) optimizing the learning method with repeated retrieval practice.
Detailed Description

Associative memory refers to remembering the association between two items, such as a face and a name or a word in English and the same word in another language. It is not only important for learning, but it is also one of the first aspects of memory performance that is impacted by aging and by Alzheimer׳s disease. For decades, neuroscientists have investigated associative learning and memory and ways to accelerate and enhance associative learning and memory.

Transcranial Direct Current stimulation (tDCS) is a non-invasive and painless electrical stimulation technique that has demonstrated to accelerate learning and improve memory in some studies. Previous research has also emphasized the importance of repeated retrieval practice as a way to accelerate learning and enhance associative memory performance. Therefore, this study will examine the effect of repeated retrieval practice on associative memory performance by using two versions of an associative memory task.

To investigate whether it is possible to accelerate learning and improve associative memory using tDCS and repeated retrieval practice, the performance in a Verbal Paired-Associate memory task during the first visit and 1 week after will be compared for four study groups. The first group will get active tDCS during a version of the verbal paired-associate learning task with repeated retrieval practice. The second group will get active tDCS during a version of the verbal paired-associate learning task without repeated retrieval practice. The third group will get sham tDCS during a version of the verbal paired-associate learning task with repeated retrieval practice and the fourth group will get Sham tDCS during a version of the verbal paired-associate learning task without repeated retrieval practice.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Adults
Intervention  ICMJE
  • Device: tDCS
    active tDCS versus sham tDCS
  • Behavioral: Verbal paired-associate learning task
    with or without repeated retrieval practice
Study Arms  ICMJE
  • Experimental: active tDCS with repeated retrieval practice
    active tDCS with verbal paired-associate learning task with repeated retrieval practice
    Interventions:
    • Device: tDCS
    • Behavioral: Verbal paired-associate learning task
  • Experimental: active tDCS without repeated retrieval practice
    active tDCS with verbal paired-associate learning task without repeated retrieval practice
    Interventions:
    • Device: tDCS
    • Behavioral: Verbal paired-associate learning task
  • Sham Comparator: Sham tDCS with repeated retrieval practice
    sham tDCS with verbal paired-associate learning task with repeated retrieval practice
    Intervention: Behavioral: Verbal paired-associate learning task
  • Sham Comparator: Sham tDCS without repeated retrieval practice
    shamtDCS with verbal paired-associate learning task without repeated retrieval practice
    Intervention: Behavioral: Verbal paired-associate learning task
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: February 14, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 22, 2020
Actual Primary Completion Date April 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age: 18-35 years
  • Native English Speaker

Exclusion Criteria:

  • History of severe head injuries,epileptic insults, or heart disease
  • Severe psychiatric disorders and severe untreated medical problems.
  • Acquainted with the foreign language used in the learning task
  • Contraindications for tDCS (pregnant women, implanted devices)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03055884
Other Study ID Numbers  ICMJE 17-34
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sven Vanneste, The University of Texas at Dallas
Study Sponsor  ICMJE The University of Texas at Dallas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sven Vanneste The University of Texas at Dallas
PRS Account The University of Texas at Dallas
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP