Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate whether we can improve associative memory performance in healthy subjects, by applying transcranial Direct Current Stimulation (tDCS) 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 improve associative memory using tDCS, the performance in a Verbal Paired-Associate memory task of 4 groups targeting different areas will be compared.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| memory task with tDCS location 1 | Experimental | memory task paired with tDCS targeting C2 nerve (anode left c2; cathode right C2) |
|
| memory task with tDCS location 2 | Experimental | memory task paired with tDCS targeting C2 nerve (anode right c2; cathode left C2) |
|
| memory task with tDCS location 3 | Experimental | memory task paired with tDCS targeting C5/6 nerve |
|
| memory task with tDCS location 4 | Experimental | memory task paired with tDCS targeting trigeminal nerve dermatomes (left and right temple/jaw) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | tDCS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Associative Memory Assessed by a Verbal Paired-Associate Test | Participants got the opportunity to learn the list of 75-word pairs across a total of eight alternating study (S) and test (T) periods. Participants came back for a final test session (all 75 words tested) 7 days later and were asked to give the English translations of Swahili words. A score was calaculated based on the percentage of words (English trnaslations) correctly recalled words. | Baseline and 1 week after the tDCS |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas of Dallas | Richardson | Texas | 75080 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | C2 Right | memory task paired with tDCS targeting the right Cranial 2 Nerve (C2) using anodal stimulation tDCS: tDCS |
| FG001 | C2 Left | memory task paired with tDCS targeting the left Cranial 2 (C2) nerve using anodal stimulation tDCS: tDCS |
| FG002 | Trigeminal Nerve | memory task paired with tDCS targeting the Trigeminal Nerve tDCS: tDCS |
| FG003 | Cranial 5/6 Nerves | memory task paired with tDCS targeting the fifth cranial nerve (C5) tDCS: tDCS |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | C2 Right | memory task paired with tDCS targeting the right Cranial 2 Nerve (C2) using anodal stimulation tDCS: tDCS |
| BG001 | C2 Left | memory task paired with tDCS targeting the left Cranial 2 (C2) nerve using anodal stimulation tDCS: 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 Verbal Paired-Associate Test | Participants got the opportunity to learn the list of 75-word pairs across a total of eight alternating study (S) and test (T) periods. Participants came back for a final test session (all 75 words tested) 7 days later and were asked to give the English translations of Swahili words. A score was calaculated based on the percentage of words (English trnaslations) correctly recalled words. | Posted | Mean | Standard Error | percentage | Baseline and 1 week after the tDCS |
|
two weeks
TES Adverse events. We use the tDCS Exit questionnaire developed by Brunoni et al. (36) to assess potential side-effect (headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, trouble concentrating, mood changes).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Memory Task With tDCS Location 1 | memory task paired with tDCS targeting location 1 tDCS: tDCS |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | UT Dallas | 972-883-7277 | Sarah.McLeod@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 | Jan 1, 2016 | Jul 8, 2020 | Prot_002.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
Participants will be randomly assigned to one of four groups: (1) tDCS targeting location 1 paired with memory task (2) tDCS targeting location 2 with memory task (3) tDCS targeting location 3 paired with memory task (4) tDCS targeting location 4 paired with memory task
Not provided
Not provided
Not provided
| BG002 | Trigeminal Nerve | memory task paired with tDCS targeting the Trigeminal Nerve tDCS: tDCS |
| BG003 | Cranial 5/6 Nerves | memory task paired with tDCS targeting the fifth cranial nerve (C5) tDCS: tDCS |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | This was not collected | That was not collected | Count of Participants | Participants |
|
| Race (NIH/OMB) | Data was not colelcted | Data was not collected | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Beck Depression Inventory Scale | 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 |
|
| Beck Anxiety Inventory Scale | 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 |
|
| Mini Mental State Examination >25 | 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. | Count of Participants | Participants |
|
| OG002 | Trigeminal Nerve | memory task paired with tDCS targeting the Trigeminal Nerve tDCS: tDCS |
| OG003 | Cranial 5/6 Nerves | memory task paired with tDCS targeting the fifth cranial nerve (C5) tDCS: tDCS |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Memory Task With tDCS Location 2 | memory task paired with tDCS targeting location 2 tDCS: tDCS | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Memory Task With tDCS Location 3 | memory task paired with tDCS targeting location 3 tDCS: tDCS | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Memory Task With tDCS Location 4 | memory task paired with tDCS targeting location 4 tDCS: tDCS | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
Not provided
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| Male |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|