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As we age, a number of factors can reduce our cognitive (or thinking) abilities. This study will evaluate whether transcranial electrical stimulation (TES), which uses small amounts of electricity to modulate brain functioning, can improve cognitive abilities. Here, the effects of TES on working memory, learning, and memory, will be evaluated in a group of healthy older adults.
The primary objective is to investigate the cognitive effects of high definition anodal tDCS (HD-tDCS; anode at center electrode) at 3 mA (for 20 minutes) on learning, memory, and working memory. Participants will be randomized to active or sham stimulation and will complete a series of cognitive tests both during and after stimulation.
Tolerability and blinding will also be evaluated using standard side effect questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active HD-tDCS | Active Comparator | Participants will receive "real" HD-tDCS (3 milliamps for 20 minutes) for a single session. |
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| Sham HD-tDCS | Sham Comparator | Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active HD-tDCS | Device | Participants will receive active HD-tDCS at 3mA for 20 minutes |
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| Measure | Description | Time Frame |
|---|---|---|
| Object Location Touchscreen Task (Version C) Free Recall Total Error | The Object Location Touchscreen Task (OLTT) is an ecologically relevant measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a black screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance. | 15 minutes after encoding |
| Object Location Touchscreen Task (Version C) Free Recall Average Error | The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance. | 15 minutes after encoding |
| Object Location Touchscreen Task (Version C) Free Recall Average Time to Respond | The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses. | 15 minutes after encoding |
| Object Location Touchscreen Task (Version C) Cued Recall Total Error |
| Measure | Description | Time Frame |
|---|---|---|
| Blinding in Total Sample | Participants were asked to estimate which group they were in (i.e., active or sham). | ~1 minute post stimulation |
| Frequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS Session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin M Hampstead, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan - Department of Psychiatry | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21320389 | Background | Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15. |
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Two participants were excluded after consent due to failing the tDCS safety screen. One participant endorsed a skin condition with lesions at site of electrode placement. One participant disclosed a prior head injury.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active HD-tDCS | Participants will receive "real" HD-tDCS (3 milliamps for 20 minutes) for a single session. Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes |
| FG001 | Sham HD-tDCS | Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session. Sham HD-tDCS: Participants will receive sham HD-tDCS |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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One participant was a statistical outlier for several behavioral measures and was excluded from baseline data and all analyses
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| ID | Title | Description |
|---|---|---|
| BG000 | Active HD-tDCS | Participants will receive "real" HD-tDCS (3 milliamps for 20 minutes) for a single session. Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes |
| BG001 | Sham HD-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 | Object Location Touchscreen Task (Version C) Free Recall Total Error | The Object Location Touchscreen Task (OLTT) is an ecologically relevant measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a black screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance. | Missing data for one participant | Posted | Mean | Standard Deviation | centimeters | 15 minutes after encoding |
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Adverse events data were collected for the duration of participation (i.e., approximately 2-3 hours)
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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 HD-tDCS | Participants will receive "real" HD-tDCS (3 milliamps for 20 minutes) for a single session. Active HD-tDCS: Participants will receive active HD-tDCS at 3mA for 20 minutes |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Annalise Rahman-Filipiak | University of Michigan | 734-763-9259 | rahmanam@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 25, 2018 | May 9, 2018 | Prot_SAP_000.pdf |
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| Sham HD-tDCS | Device | Participants will receive sham HD-tDCS |
|
The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance. |
| 15 minutes after encoding |
| Object Location Touchscreen Task (Version C) Cued Recall Average Error | The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance. | 15 minutes after encoding |
| Object Location Touchscreen Task (Version C) Cued Recall Average Time to Respond | The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses. | 15 minutes after encoding |
| Object Location Touchscreen Task (Version C) Recognition Total Correct | The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition total is the number of correct selections on all 15 trials. Higher scores represent better performance. | 15 minutes after encoding |
| Object Location Touchscreen Task (Version C) Recognition Average Time to Respond | The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition Average Response Time is the average latency to respond across all 15 trials. Lower scores represent faster responses. | 15 minutes after encoding |
| Performance (d') on a Simple Attention (0-back) Test | The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability. | 30 minutes post-stimulation |
| Performance (d') on a Working Memory (2-back) Test | The n-back is a well validated measure of working memory. During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability. | 30 minutes post-stimulation |
| Performance (d') on a Working Memory (Semantic 2-back) Test | The n-back is a well validated measure of working memory. During Semantic-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability. | 30 minutes post-stimulation |
| Calculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d') | The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance. | 30 minutes post-stimulation |
| Calculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d') | The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During Semantic 2-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance. | 30 minutes post-stimulation |
The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".
| ~1 minute post stimulation |
| Frequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | ~1 minute post stimulation |
| Frequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | ~1 minute post stimulation |
| Frequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | ~1 minute post stimulation |
| Frequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | ~1 minute post stimulation |
| Frequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | ~1 minute post stimulation |
| Frequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | ~1 minute post stimulation |
| Frequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | ~1 minute post stimulation |
| Frequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | ~1 minute post stimulation |
| Frequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | ~1 minute post stimulation |
Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.
Sham HD-tDCS: Participants will receive sham HD-tDCS
| 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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| Mini-Mental State Examination | The Mini Mental-State Examination is a 30-item global cognitive screen. Scores range from 0-30 with higher scores represent better performances and scores 23 and below are suggestive of cognitive impairment. | Participants were not screened if an MMSE was completed within the past six months as part of their involvement with the Michigan Alzheimer's Disease Center (n = 2) | Mean | Standard Deviation | units on a scale |
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| Education | Missing data for two participants | Mean | Standard Deviation | years |
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| Impedance | The first impedance reading averaged across all five electrodes. The unit measured is in "Quality Units" as produced by the Soterix transcranial direct current stimulation machine, which is a proprietary measurement of impedance. Lower values represent less impedance. | Mean | Standard Deviation | quality units |
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| Object Location Touchscreen Task (Version B) Free Recall Total Error | The Object Location Touchscreen Task (OLTT) is an ecologically relevant measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a black screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance. | Mean | Standard Deviation | centimeters |
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| Object Location Touchscreen Task (Version B) Free Recall Average Error | The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance. | Mean | Standard Deviation | centimeters |
|
| Object Location Touchscreen Task (Version B) Free Recall Average Time to Respond | The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses. | Mean | Standard Deviation | milliseconds |
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| Object Location Touchscreen Task (Version B) Cued Recall Total Error | The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance. | Mean | Standard Deviation | centimeters |
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| Object Location Touchscreen Task (Version B) Cued Recall Average Error | The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance. | Mean | Standard Deviation | centimeters |
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| Object Location Touchscreen Task (Version B) Cued Recall Average Time to Respond | The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses. | Mean | Standard Deviation | milliseconds |
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| Object Location Touchscreen Task (Version B) Recognition Total Correct | The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition total is the number of correct selections on all 15 trials. Higher scores represent better performance. | Mean | Standard Deviation | number of correct answers |
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| Object Location Touchscreen Task (Version B) Recognition Average Time to Respond | The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition Average Response Time is the average latency to respond across all 15 trials. Lower scores represent faster responses. | Mean | Standard Deviation | milliseconds |
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| OG001 | Sham HD-tDCS | Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session. Sham HD-tDCS: Participants will receive sham HD-tDCS |
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| Primary | Object Location Touchscreen Task (Version C) Free Recall Average Error | The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance. | Missing data for one participant | Posted | Mean | Standard Deviation | centimeters | 15 minutes after encoding |
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| Primary | Object Location Touchscreen Task (Version C) Free Recall Average Time to Respond | The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses. | Missing data for one participant | Posted | Mean | Standard Deviation | milliseconds | 15 minutes after encoding |
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| Primary | Object Location Touchscreen Task (Version C) Cued Recall Total Error | The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance. | Missing data for one participant | Posted | Mean | Standard Deviation | centimeters | 15 minutes after encoding |
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| Primary | Object Location Touchscreen Task (Version C) Cued Recall Average Error | The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance. | Missing data for one participant | Posted | Mean | Standard Deviation | centimeters | 15 minutes after encoding |
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| Primary | Object Location Touchscreen Task (Version C) Cued Recall Average Time to Respond | The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses. | Missing data for one participant | Posted | Mean | Standard Deviation | milliseconds | 15 minutes after encoding |
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| Primary | Object Location Touchscreen Task (Version C) Recognition Total Correct | The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition total is the number of correct selections on all 15 trials. Higher scores represent better performance. | Missing data for one participant | Posted | Mean | Standard Deviation | number of correct answers | 15 minutes after encoding |
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| Primary | Object Location Touchscreen Task (Version C) Recognition Average Time to Respond | The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition Average Response Time is the average latency to respond across all 15 trials. Lower scores represent faster responses. | Missing data for one participant | Posted | Mean | Standard Deviation | milliseconds | 15 minutes after encoding |
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| Primary | Performance (d') on a Simple Attention (0-back) Test | The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability. | missing data for two participants | Posted | Mean | Standard Deviation | d' | 30 minutes post-stimulation |
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| Primary | Performance (d') on a Working Memory (2-back) Test | The n-back is a well validated measure of working memory. During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability. | missing data for two participants | Posted | Mean | Standard Deviation | d' | 30 minutes post-stimulation |
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| Primary | Performance (d') on a Working Memory (Semantic 2-back) Test | The n-back is a well validated measure of working memory. During Semantic-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability. | missing data for eleven participants (5 Active; 6 Sham) due to Eprime miscalculation | Posted | Mean | Standard Deviation | d' | 30 minutes post-stimulation |
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| Primary | Calculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d') | The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance. | missing data for 12 participants: 11 2-back (5 Active; 6 sham) due to Eprime miscalculation & one 0-back (Active) | Posted | Mean | Standard Deviation | d' | 30 minutes post-stimulation |
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| Primary | Calculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d') | The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During Semantic 2-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance. | missing data for two participants | Posted | Mean | Standard Deviation | d' | 30 minutes post-stimulation |
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| Secondary | Blinding in Total Sample | Participants were asked to estimate which group they were in (i.e., active or sham). | Posted | Count of Participants | Participants | ~1 minute post stimulation |
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| Secondary | Frequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | Posted | Count of Participants | Participants | ~1 minute post stimulation |
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| Secondary | Frequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | Posted | Count of Participants | Participants | ~1 minute post stimulation |
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| Secondary | Frequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | Posted | Count of Participants | Participants | ~1 minute post stimulation |
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| Secondary | Frequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | Posted | Count of Participants | Participants | ~1 minute post stimulation |
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| Secondary | Frequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | Posted | Count of Participants | Participants | ~1 minute post stimulation |
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| Secondary | Frequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | Posted | Count of Participants | Participants | ~1 minute post stimulation |
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|
|
| Secondary | Frequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | Posted | Count of Participants | Participants | ~1 minute post stimulation |
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| Secondary | Frequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | Posted | Count of Participants | Participants | ~1 minute post stimulation |
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| Secondary | Frequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | Posted | Count of Participants | Participants | ~1 minute post stimulation |
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| Secondary | Frequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS Session | The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe". | Posted | Count of Participants | Participants | ~1 minute post stimulation |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 16 |
| 19 |
| EG001 | Sham HD-tDCS | Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session. Sham HD-tDCS: Participants will receive sham HD-tDCS | 0 | 21 | 0 | 21 | 19 | 21 |
| Neck Pain | General disorders | Systematic Assessment |
|
| Scalp Pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Tingling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Burning sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sleepiness | General disorders | Systematic Assessment |
|
| Concentration Changes | General disorders | Systematic Assessment |
|
| Mood Changes | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Univariate analysis of the OLTT Free Recall Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham). | Repeated Measures ANOVA | .006 | Other |
| Said Don't Know |
|
| Headache MODERATE |
|
| Headache SEVERE |
|
| Neck Pain MODERATE |
|
| Neck Pain SEVERE |
|
| MODERATE |
|
| SEVERE |
|
| MODERATE |
|
| SEVERE |
|
| MODERATE |
|
| SEVERE |
|
| MODERATE |
|
| SEVERE |
|
| MODERATE |
|
| SEVERE |
|
| MODERATE |
|
| SEVERE |
|
| MODERATE |
|
| SEVERE |
|
| MODERATE |
|
| SEVERE |
|