Investigating Accelerated Learning in Healthy Subjects

• ClinicalTrials.gov Identifier: NCT03055884
• Recruitment Status: Suspended
• First Posted: February 16, 2017
• Last Update Posted: November 4, 2020
• Sponsor: The University of Texas at Dallas
• Information provided by (Responsible Party): Sven Vanneste, The University of Texas at Dallas

Tracking Information

• First Submitted Date: February 14, 2017
• First Posted Date: February 16, 2017
• Last Update Posted Date: November 4, 2020
• Actual Study Start Date: February 13, 2017
• Actual Primary Completion Date: April 22, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Investigating Accelerated Learning in Healthy Subjects
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Basic Science
• Condition: Healthy Adults

Intervention

• Device: tDCS
  active tDCS versus sham tDCS
• Behavioral: Verbal paired-associate learning task
  with or without repeated retrieval practice

Study Arms

• 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

Recruitment Information

• Recruitment Status: Suspended
• Estimated Enrollment (submitted: February 14, 2017): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 22, 2020
• Actual Primary Completion Date: April 22, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03055884
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Responsible Party: Sven Vanneste, The University of Texas at Dallas
• Study Sponsor: The University of Texas at Dallas
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sven Vanneste; The University of Texas at Dallas

• PRS Account: The University of Texas at Dallas
• Verification Date: November 2020