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The purpose of this study is to investigate whether it is possible to accelerate learning and improve associative memory performance in healthy subjects, by applying transcranial Direct Current Stimulation (tDCS) targeting the trigeminal nerve during a verbal paired-associate learning 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 it is possible to accelerate learning and improve associative memory using tDCS, the performance in a Verbal Paired-Associate memory task of 2 groups will be compared. The first group will get active tDCS during the verbal paired-associate learning task. The second group will get sham tDCS during the verbal paired-associate learning task.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | Active transcranial Direct Current Stimulation targeting the trigeminal nerve |
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| Sham tDCS | Sham Comparator | Sham transcranial Direct Current Stimulation targeting the trigeminal nerve |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS | Device | Transcranial Direct Current Stimulation targeting the trigeminal nerve |
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| Measure | Description | Time Frame |
|---|---|---|
| Associative Memory Assessed by a Verbal Paired-Associate Test | Changes in performance in the Verbal Paired-Associate memory task is compared between the 2 groups (1. Active tDCS 2. Sham tDCS) to investigate the influence of tDCS on Associative Memory. | 1 week after stimualtion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sven Vanneste | 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 transcranial Direct Current Stimulation targeting the trigeminal nerve Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve |
| FG001 | Sham tDCS | Sham transcranial Direct Current Stimulation targeting the trigeminal nerve Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS | Active transcranial Direct Current Stimulation targeting the trigeminal nerve Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve |
| BG001 | Sham tDCS |
| Units | Counts |
|---|---|
| Participants |
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| 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 Verbal Paired-Associate Test | Changes in performance in the Verbal Paired-Associate memory task is compared between the 2 groups (1. Active tDCS 2. Sham tDCS) to investigate the influence of tDCS on Associative Memory. | Posted | Mean | Standard Deviation | percentage of words recalled from V1 | 1 week after stimualtion |
|
One Week
Before the end of the experiment, participants were asked to fill out a questionnaire (Brunoni et al., 2011) to assess their experiences of possible side effects (e.g., headache, neck pain, and scalp pain) related to the stimulation on a 4-point scale (1 = absent, 2 = mild, 3 = moderate, and 4 = severe).
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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 transcranial Direct Current Stimulation targeting the trigeminal nerve Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve |
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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 17-34 TN | Jan 1, 2016 | Jul 8, 2020 | Prot_001.pdf |
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participants will be randomly assigned to one of 2 groups: (1) active tDCS (2) sham tDCS
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Sham transcranial Direct Current Stimulation targeting the trigeminal nerve Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Beck Depression Inventory Scale | Measure Description: Measure Description: 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 |
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| Beck Anxiety Inventory Scale | Measure Description: Measure Description: 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 are: 0-7: minimal anxiety 8-15: mild anxiety 16-25: moderate anxiety 26-63: severe anxiety | Mean | Standard Deviation | units on a scale |
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| Mini Mental State Examination | Measure Description: Measure Description: 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 |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Sham tDCS | Sham transcranial Direct Current Stimulation targeting the trigeminal nerve Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS: Transcranial Direct Current Stimulation targeting the trigeminal nerve | 0 | 10 | 0 | 10 | 0 | 10 |
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