Patient Centered-Rehabilitation ver111090.1
- Conditions
- Cognitive Change
- Interventions
- Device: Sham HD-tDCSDevice: Active HD-tDCS
- Registration Number
- NCT03034954
- Lead Sponsor
- University of Michigan
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Individuals with intact cognitive functioning.
- Participants will be age 50 or older.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham HD-tDCS Sham HD-tDCS Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session. Active HD-tDCS Active HD-tDCS Participants will receive "real" HD-tDCS (3 milliamps for 20 minutes) for a single session.
- Primary Outcome Measures
Name Time Method Object Location Touchscreen Task (Version C) Free Recall Average Error 15 minutes after encoding 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.
Object Location Touchscreen Task (Version C) Free Recall Average Time to Respond 15 minutes after encoding 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.
Object Location Touchscreen Task (Version C) Cued Recall Average Error 15 minutes after encoding 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.
Object Location Touchscreen Task (Version C) Free Recall Total Error 15 minutes after encoding 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.
Object Location Touchscreen Task (Version C) Recognition Average Time to Respond 15 minutes after encoding 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.
Calculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d') 30 minutes post-stimulation 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.
Object Location Touchscreen Task (Version C) Recognition Total Correct 15 minutes after encoding 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.
Performance (d') on a Working Memory (2-back) Test 30 minutes post-stimulation 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.
Object Location Touchscreen Task (Version C) Cued Recall Total Error 15 minutes after encoding 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.
Object Location Touchscreen Task (Version C) Cued Recall Average Time to Respond 15 minutes after encoding 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.
Performance (d') on a Simple Attention (0-back) Test 30 minutes post-stimulation 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.
Performance (d') on a Working Memory (Semantic 2-back) Test 30 minutes post-stimulation 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.
Calculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d') 30 minutes post-stimulation 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.
- Secondary Outcome Measures
Name Time Method Blinding in Total Sample ~1 minute post stimulation Participants were asked to estimate which group they were in (i.e., active or sham).
Frequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS Session ~1 minute 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".
Frequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS Session ~1 minute 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".
Frequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS Session ~1 minute 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".
Frequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS Session ~1 minute 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".
Frequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS Session ~1 minute 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".
Frequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS Session ~1 minute 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".
Frequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS Session ~1 minute 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".
Frequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS Session ~1 minute 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".
Frequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS Session ~1 minute 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".
Frequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS Session ~1 minute 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".
Trial Locations
- Locations (1)
University of Michigan - Department of Psychiatry
🇺🇸Ann Arbor, Michigan, United States