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The purpose of this study is to investigate whether we can accelerate learning and improve associative memory performance in healthy subjects by applying transcranial Direct Current Stimulation (tDCS) during a Face Name memory task.
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. To investigate whether we can accelerate learning and improve associative memory using tDCS, we will compare the performance in a Face Name Associate memory task from 2 groups. The first group will get active tDCS during the study phase of the Face Name Memory task, whereas the second group will get sham tDCS during the study phase of the task.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active tDCS | Experimental | active tDCS with Face Name associate Memory task |
|
| sham tDCS | Sham Comparator | sham tDCS with Face Name associate Memory task |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | active tDCS |
| |
| sham tDCS |
| Measure | Description | Time Frame |
|---|---|---|
| Associative Memory Assessed by a Face Name Associate Memory Experiment | All participants performed a face memory task .The face stimuli consisted of 120 grayscale pictures of human faces. Only faces with a neutral expression facing forward were selected. Half of the faces were male, and the other half were female. The face-name association memory task was divided into (1) an encoding phase, (2) a consolidation phase, and (3) a retrieval phase. During the encoding phase, participants studied 60 successively presented face-name pairs and were instructed to assess their gender to keep them focused to the task. The encoding phase was followed by a consolidation phase where participants were instructed to "sit still, relax, and think about nothing in particular" for 10 minutes, During the retrieval phase, participants were presented with 60 old and 60 new faces and were instructed to assess whether they have seen this face during the encoding phase. The outcome was the percent of Correct Name to Face Matches | Associate Memory is assessed after a 10 minutes break following the study phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sven Vanneste, PhD | The University of Texas at Dallas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas of Dallas | Richardson | Texas | 75080 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active tDCS | active tDCS with Face Name associate Memory task tDCS: active tDCS |
| FG001 | Sham tDCS | sham tDCS with Face Name associate Memory task sham tDCS: sham tDCS |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS | active tDCS with Face Name associate Memory task tDCS: active tDCS |
| BG001 | Sham tDCS | sham tDCS with Face Name associate Memory task sham tDCS: sham tDCS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Associative Memory Assessed by a Face Name Associate Memory Experiment | All participants performed a face memory task .The face stimuli consisted of 120 grayscale pictures of human faces. Only faces with a neutral expression facing forward were selected. Half of the faces were male, and the other half were female. The face-name association memory task was divided into (1) an encoding phase, (2) a consolidation phase, and (3) a retrieval phase. During the encoding phase, participants studied 60 successively presented face-name pairs and were instructed to assess their gender to keep them focused to the task. The encoding phase was followed by a consolidation phase where participants were instructed to "sit still, relax, and think about nothing in particular" for 10 minutes, During the retrieval phase, participants were presented with 60 old and 60 new faces and were instructed to assess whether they have seen this face during the encoding phase. The outcome was the percent of Correct Name to Face Matches | Posted | Mean | Standard Deviation | Percent of Correct Name to Face Matches | Associate Memory is assessed after a 10 minutes break following the study phase |
|
1 week
At the end of the stimulation procedure, participants complete an exit questionnaire on which they can report side-effects from the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active tDCS | active tDCS with Face Name associate Memory task tDCS: active tDCS |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sven Vanneste, Principal Investigator | University of Texas at Dallas | 972-883-7277 | sven.vanneste@utdallas.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Protocol 17-96 | Jan 1, 2016 | Jul 8, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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Participants will be randomly assigned to one of two groups: (1) active tDCS with Face Name associate memory task (2) sham tDCS with Face Name associate memory task
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| Device |
sham tDCS |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Beck Depression Inventory Scale | The Beck Depression Inventory (BDI, BDI-1A, BDI-II), created by Aaron T. Beck, is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. The Beck Depression Inventory uses the following scale to assess patients: 0 - 13: Minimal depression, 14 - 19: Mild depression, 20 - 28: Moderate depression, 29 - 63: Severe depression Min score: 0; Max Score: 63; The higher the score the more mood | Mean | Standard Deviation | units on a scale |
|
| Beck Anxiety Inventory Scale | The Beck Anxiety Inventory (BAI), created by Aaron T. Beck and other colleagues, is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults. The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs[4] are: 0-7: minimal anxiety 8-15: mild anxiety 16-25: moderate anxiety 26-63: severe anxiety | Mean | Standard Deviation | units on a scale |
|
| Mini Mental State Examination | The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. | Mean | Standard Deviation | units on a scale |
|
| Profile of Mood States- Mood Disturbance | The Profile of Mood States (POMS) is a psychological rating scale used to access transient, distinct mood states. The total score is reported. The higher the score the more people are sensitive to mood swings. Min score 0 - Max score is 148. | Mean | Standard Deviation | units on a scale |
|
| OG000 | Active tDCS | active tDCS with Face Name associate Memory task tDCS: active tDCS |
| OG001 | Sham tDCS | sham tDCS with Face Name associate Memory task sham tDCS: sham tDCS |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Sham tDCS | sham tDCS with Face Name associate Memory task sham tDCS: sham tDCS | 0 | 15 | 0 | 15 | 0 | 15 |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |