Patient Centered-Rehabilitation ver111090.1

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of 3mA HD-tDCS on Associative and Working Memory in Cognitively Intact Older Adults

Conditions
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Cognitive Change

Intervention / Treatment
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* Device: Active HD-tDCS
* Device: Sham HD-tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals with intact cognitive functioning. Participants will be age 50 or older. Exclusion Criteria: Individuals with a documented history of cognitive impairment. A history of serious mental illness (e.g., bipolar disorder, schizophrenia, axis 2 disorders) Sensory or motor impairments that limit the ability to take part in the study A significant history or current use of alcohol or drug abuse/dependence Those who are currently pregnant (if there is a question of pregnancy, pregnancy tests will be available for participants at no charge) Participants with an Mini Mental State Examination score <24 at screening.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active HD-tDCS<br>Participants will receive real HD-tDCS (3 milliamps for 20 minutes) for a single session. | Device: Active HD-tDCS<br>* Participants will receive active HD-tDCS at 3mA for 20 minutes<br>* Other names: HD-tDCS;|
| Sham Comparator: Sham HD-tDCS<br>Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session. | Device: Sham HD-tDCS<br>* Participants will receive sham HD-tDCS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |