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Patient Centered-Rehabilitation ver111090.1

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03034954
Acronym
PCN1
Enrollment
42
Registered
2017-01-27
Start date
2016-10-31
Completion date
2017-10-31
Last updated
2018-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Change

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.

Interventions

Participants will receive active HD-tDCS at 3mA for 20 minutes

Participants will receive sham HD-tDCS

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Individuals with intact cognitive functioning. 2. Participants will be age 50 or older.

Exclusion criteria

1. Individuals with a documented history of cognitive impairment. 2. A history of serious mental illness (e.g., bipolar disorder, schizophrenia, axis 2 disorders) 3. Sensory or motor impairments that limit the ability to take part in the study 4. A significant history or current use of alcohol or drug abuse/dependence 5. Those who are currently pregnant (if there is a question of pregnancy, pregnancy tests will be available for participants at no charge) 6. Participants with an Mini Mental State Examination score \<24 at screening.

Design outcomes

Primary

MeasureTime frameDescription
Calculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d')30 minutes post-stimulationThe 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) Free Recall Average Error15 minutes after encodingThe 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 Respond15 minutes after encodingThe 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 Total Error15 minutes after encodingThe 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 Error15 minutes after encodingThe 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) Cued Recall Average Time to Respond15 minutes after encodingThe 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.
Object Location Touchscreen Task (Version C) Recognition Total Correct15 minutes after encodingThe 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.
Object Location Touchscreen Task (Version C) Recognition Average Time to Respond15 minutes after encodingThe 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.
Performance (d') on a Simple Attention (0-back) Test30 minutes post-stimulationThe 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 (2-back) Test30 minutes post-stimulationThe 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.
Performance (d') on a Working Memory (Semantic 2-back) Test30 minutes post-stimulationThe 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-stimulationThe 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.
Object Location Touchscreen Task (Version C) Free Recall Total Error15 minutes after encodingThe 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.

Secondary

MeasureTime frameDescription
Frequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS Session~1 minute post stimulationThe 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 stimulationThe 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 Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS Session~1 minute post stimulationThe 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 stimulationThe 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 stimulationThe 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 stimulationThe 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 stimulationThe 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 stimulationThe 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 stimulationThe 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 stimulationThe 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.
Blinding in Total Sample~1 minute post stimulationParticipants were asked to estimate which group they were in (i.e., active or sham).

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
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
19
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
21
Total40

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyMachine malfunction; did not reach 3 mA10

Baseline characteristics

CharacteristicActive HD-tDCSSham HD-tDCSTotal
Age, Continuous66.42 years
STANDARD_DEVIATION 8.546
65.38 years
STANDARD_DEVIATION 10.604
65.88 years
STANDARD_DEVIATION 9.573
Education16.82 years
STANDARD_DEVIATION 1.59
16.48 years
STANDARD_DEVIATION 2.089
16.63 years
STANDARD_DEVIATION 1.866
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants21 Participants40 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Impedance0.9512 quality units
STANDARD_DEVIATION 0.4004
0.8939 quality units
STANDARD_DEVIATION 0.06314
0.921 quality units
STANDARD_DEVIATION 0.528
Mini-Mental State Examination28.58 units on a scale
STANDARD_DEVIATION 1.216
28.37 units on a scale
STANDARD_DEVIATION 1.212
28.47 units on a scale
STANDARD_DEVIATION 1.202
Object Location Touchscreen Task (Version B) Cued Recall Average Error4.971 centimeters
STANDARD_DEVIATION 3.422
3.002 centimeters
STANDARD_DEVIATION 2.574
3.937 centimeters
STANDARD_DEVIATION 3.129
Object Location Touchscreen Task (Version B) Cued Recall Average Time to Respond3855.83 milliseconds
STANDARD_DEVIATION 2452.1
3307.879 milliseconds
STANDARD_DEVIATION 1605.689
3568.155 milliseconds
STANDARD_DEVIATION 2043.063
Object Location Touchscreen Task (Version B) Cued Recall Total Error74.513 centimeters
STANDARD_DEVIATION 51.385
45.055 centimeters
STANDARD_DEVIATION 38.61
59.048 centimeters
STANDARD_DEVIATION 46.958
Object Location Touchscreen Task (Version B) Free Recall Average Error7.685 centimeters
STANDARD_DEVIATION 2.963
6.835 centimeters
STANDARD_DEVIATION 2.97
7.239 centimeters
STANDARD_DEVIATION 2.96
Object Location Touchscreen Task (Version B) Free Recall Average Time to Respond3796.361 milliseconds
STANDARD_DEVIATION 1188.015
4921.558 milliseconds
STANDARD_DEVIATION 2306.631
4387.09 milliseconds
STANDARD_DEVIATION 1924.503
Object Location Touchscreen Task (Version B) Free Recall Total Error115.27 centimeters
STANDARD_DEVIATION 44.445
102.534 centimeters
STANDARD_DEVIATION 6.835
108.583 centimeters
STANDARD_DEVIATION 7.239
Object Location Touchscreen Task (Version B) Recognition Average Time to Respond3005.095 milliseconds
STANDARD_DEVIATION 1807.47
2456.063 milliseconds
STANDARD_DEVIATION 1164.46
2716.853 milliseconds
STANDARD_DEVIATION 1510.062
Object Location Touchscreen Task (Version B) Recognition Total Correct13.11 number of correct answers
STANDARD_DEVIATION 1.941
14.05 number of correct answers
STANDARD_DEVIATION 1.322
13.6 number of correct answers
STANDARD_DEVIATION 1.692
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
18 Participants19 Participants37 Participants
Region of Enrollment
United States
19 Participants21 Participants40 Participants
Sex: Female, Male
Female
11 Participants16 Participants27 Participants
Sex: Female, Male
Male
8 Participants5 Participants13 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 190 / 21
other
Total, other adverse events
16 / 1919 / 21
serious
Total, serious adverse events
0 / 190 / 21

Outcome results

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.

Time frame: 30 minutes post-stimulation

Population: missing data for 12 participants: 11 2-back (5 Active; 6 sham) due to Eprime miscalculation \& one 0-back (Active)

ArmMeasureValue (MEAN)Dispersion
Active HD-tDCSCalculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d')-1.130 d'Standard Deviation 0.629
Sham HD-tDCSCalculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d')-1.31 d'Standard Deviation 0.675
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.

Time frame: 30 minutes post-stimulation

Population: missing data for two participants

ArmMeasureValue (MEAN)Dispersion
Active HD-tDCSCalculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d')-2.69 d'Standard Deviation 0.58
Sham HD-tDCSCalculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d')-2.56 d'Standard Deviation 0.47
Comparison: A Multivariate ANOVA was used to compare Active vs. Sham groups on discriminability measures (i.e. 0-back d', 2-back d', semantic 2-back d') and calculated working memory measures (i.e., 2-back d' minus 0-back d', semantic 2-back d' minus 0-back d').p-value: 0.45MANOVA
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.

Time frame: 15 minutes after encoding

Population: Missing data for one participant

ArmMeasureValue (MEAN)Dispersion
Active HD-tDCSObject Location Touchscreen Task (Version C) Cued Recall Average Error4.453 centimetersStandard Deviation 1.954
Sham HD-tDCSObject Location Touchscreen Task (Version C) Cued Recall Average Error2.919 centimetersStandard Deviation 1.954
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.

Time frame: 15 minutes after encoding

Population: Missing data for one participant

ArmMeasureValue (MEAN)Dispersion
Active HD-tDCSObject Location Touchscreen Task (Version C) Cued Recall Average Time to Respond3991.659 millisecondsStandard Deviation 2218.596
Sham HD-tDCSObject Location Touchscreen Task (Version C) Cued Recall Average Time to Respond2666.858 millisecondsStandard Deviation 866.887
Comparison: Univariate analysis of the OLTT Cued 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).p-value: 0.15Repeated Measures ANOVA
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.

Time frame: 15 minutes after encoding

Population: Missing data for one participant

ArmMeasureValue (MEAN)Dispersion
Active HD-tDCSObject Location Touchscreen Task (Version C) Cued Recall Total Error66.806 centimetersStandard Deviation 29.303
Sham HD-tDCSObject Location Touchscreen Task (Version C) Cued Recall Total Error43.775 centimetersStandard Deviation 29.32
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.

Time frame: 15 minutes after encoding

Population: Missing data for one participant

ArmMeasureValue (MEAN)Dispersion
Active HD-tDCSObject Location Touchscreen Task (Version C) Free Recall Average Error8.099 centimetersStandard Deviation 1.757
Sham HD-tDCSObject Location Touchscreen Task (Version C) Free Recall Average Error6.652 centimetersStandard Deviation 1.856
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.

Time frame: 15 minutes after encoding

Population: Missing data for one participant

ArmMeasureValue (MEAN)Dispersion
Active HD-tDCSObject Location Touchscreen Task (Version C) Free Recall Average Time to Respond3419.878 millisecondsStandard Deviation 1690.354
Sham HD-tDCSObject Location Touchscreen Task (Version C) Free Recall Average Time to Respond3029.648 millisecondsStandard Deviation 1572.416
Comparison: A Repeated Measures ANOVA was used to compare baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham). The multivariate analyses included OLTT Response Times (i.e., Free Recall Average Response Time, Cued Recall Average Response Time, Recognition Average Response Time)p-value: 0.044Repeated Measures ANOVA
Comparison: 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).p-value: 0.006Repeated Measures ANOVA
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.

Time frame: 15 minutes after encoding

Population: Missing data for one participant

ArmMeasureValue (MEAN)Dispersion
Active HD-tDCSObject Location Touchscreen Task (Version C) Free Recall Total Error121.498 centimetersStandard Deviation 26.366
Sham HD-tDCSObject Location Touchscreen Task (Version C) Free Recall Total Error99.77 centimetersStandard Deviation 27.845
Comparison: We used a multivariate statistic to compare OLTT means (Free Recall Total Error, Free Recall Average Error, Cued Recall Total Error, Cued Recall Average Error, Recognition Total Correct) at baseline (Version B) to post HD-tDCS OLTT means (Version C), by groups (active vs. sham). The overall statistic represents the simultaneous comparison of baseline OLTT measures to post HD-tDCS OLTT measures.p-value: 0.3Repeated Measures ANOVA
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.

Time frame: 15 minutes after encoding

Population: Missing data for one participant

ArmMeasureValue (MEAN)Dispersion
Active HD-tDCSObject Location Touchscreen Task (Version C) Recognition Average Time to Respond2804.459 millisecondsStandard Deviation 1244.249
Sham HD-tDCSObject Location Touchscreen Task (Version C) Recognition Average Time to Respond1903.39 millisecondsStandard Deviation 843.244
Comparison: Univariate analysis of the OLTT Recognition 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).p-value: 0.3Repeated Measures ANOVA
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.

Time frame: 15 minutes after encoding

Population: Missing data for one participant

ArmMeasureValue (MEAN)Dispersion
Active HD-tDCSObject Location Touchscreen Task (Version C) Recognition Total Correct12.79 number of correct answersStandard Deviation 1.932
Sham HD-tDCSObject Location Touchscreen Task (Version C) Recognition Total Correct13.45 number of correct answersStandard Deviation 1.669
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.

Time frame: 30 minutes post-stimulation

Population: missing data for two participants

ArmMeasureValue (MEAN)Dispersion
Active HD-tDCSPerformance (d') on a Simple Attention (0-back) Test4.26 d'Standard Deviation 0.231
Sham HD-tDCSPerformance (d') on a Simple Attention (0-back) Test4.25 d'Standard Deviation 0.219
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.

Time frame: 30 minutes post-stimulation

Population: missing data for two participants

ArmMeasureValue (MEAN)Dispersion
Active HD-tDCSPerformance (d') on a Working Memory (2-back) Test3.05 d'Standard Deviation 0.508
Sham HD-tDCSPerformance (d') on a Working Memory (2-back) Test2.94 d'Standard Deviation 0.675
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.

Time frame: 30 minutes post-stimulation

Population: missing data for eleven participants (5 Active; 6 Sham) due to Eprime miscalculation

ArmMeasureValue (MEAN)Dispersion
Active HD-tDCSPerformance (d') on a Working Memory (Semantic 2-back) Test1.518 d'Standard Deviation 0.537
Sham HD-tDCSPerformance (d') on a Working Memory (Semantic 2-back) Test1.69 d'Standard Deviation 0.495
Secondary

Blinding in Total Sample

Participants were asked to estimate which group they were in (i.e., active or sham).

Time frame: ~1 minute post stimulation

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Active HD-tDCSBlinding in Total SampleSaid Active9 Participants
Active HD-tDCSBlinding in Total SampleSaid Sham9 Participants
Active HD-tDCSBlinding in Total SampleSaid Don't Know1 Participants
Sham HD-tDCSBlinding in Total SampleSaid Active6 Participants
Sham HD-tDCSBlinding in Total SampleSaid Sham8 Participants
Sham HD-tDCSBlinding in Total SampleSaid Don't Know7 Participants
Comparison: Chi-squared tests were conducted to determine group differences in actual condition assignment vs. estimated/perceived conditionp-value: 0.078Chi-squared
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.

Time frame: ~1 minute post stimulation

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Active HD-tDCSFrequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS SessionNONE9 Participants
Active HD-tDCSFrequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS SessionMILD10 Participants
Active HD-tDCSFrequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS SessionMODERATE0 Participants
Active HD-tDCSFrequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS SessionSEVERE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS SessionSEVERE1 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS SessionNONE7 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS SessionMODERATE5 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS SessionMILD8 Participants
p-value: 0.082Fisher Exact
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.

Time frame: ~1 minute post stimulation

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Active HD-tDCSFrequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS SessionNONE17 Participants
Active HD-tDCSFrequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS SessionMILD2 Participants
Active HD-tDCSFrequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS SessionMODERATE0 Participants
Active HD-tDCSFrequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS SessionSEVERE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS SessionSEVERE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS SessionNONE21 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS SessionMODERATE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS SessionMILD0 Participants
p-value: 0.219Fisher Exact
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.

Time frame: ~1 minute post stimulation

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Active HD-tDCSFrequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS SessionHeadache NONE19 Participants
Active HD-tDCSFrequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS SessionHeadache MILD0 Participants
Active HD-tDCSFrequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS SessionHeadache MODERATE0 Participants
Active HD-tDCSFrequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS SessionHeadache SEVERE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS SessionHeadache SEVERE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS SessionHeadache NONE18 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS SessionHeadache MODERATE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS SessionHeadache MILD3 Participants
p-value: 0.233Fisher Exact
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.

Time frame: ~1 minute post stimulation

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Active HD-tDCSFrequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS SessionNONE16 Participants
Active HD-tDCSFrequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS SessionMILD3 Participants
Active HD-tDCSFrequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS SessionMODERATE0 Participants
Active HD-tDCSFrequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS SessionSEVERE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS SessionSEVERE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS SessionNONE14 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS SessionMODERATE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS SessionMILD7 Participants
p-value: 0.281Fisher Exact
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.

Time frame: ~1 minute post stimulation

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Active HD-tDCSFrequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS SessionNONE19 Participants
Active HD-tDCSFrequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS SessionMILD0 Participants
Active HD-tDCSFrequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS SessionMODERATE0 Participants
Active HD-tDCSFrequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS SessionSEVERE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS SessionSEVERE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS SessionNONE21 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS SessionMODERATE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS SessionMILD0 Participants
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.

Time frame: ~1 minute post stimulation

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Active HD-tDCSFrequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS SessionNeck Pain NONE19 Participants
Active HD-tDCSFrequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS SessionNeck Pain MODERATE0 Participants
Active HD-tDCSFrequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS SessionNeck Pain SEVERE0 Participants
Active HD-tDCSFrequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS SessionNeck Pain MILD0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS SessionNeck Pain SEVERE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS SessionNeck Pain NONE21 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS SessionNeck Pain MILD0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS SessionNeck Pain MODERATE0 Participants
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.

Time frame: ~1 minute post stimulation

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Active HD-tDCSFrequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS SessionNONE16 Participants
Active HD-tDCSFrequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS SessionMILD1 Participants
Active HD-tDCSFrequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS SessionMODERATE1 Participants
Active HD-tDCSFrequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS SessionSEVERE1 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS SessionSEVERE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS SessionNONE20 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS SessionMODERATE1 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS SessionMILD0 Participants
p-value: 0.6Fisher Exact
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.

Time frame: ~1 minute post stimulation

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Active HD-tDCSFrequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS SessionNONE19 Participants
Active HD-tDCSFrequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS SessionMILD0 Participants
Active HD-tDCSFrequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS SessionMODERATE0 Participants
Active HD-tDCSFrequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS SessionSEVERE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS SessionSEVERE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS SessionNONE19 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS SessionMODERATE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS SessionMILD2 Participants
p-value: 0.49Fisher Exact
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.

Time frame: ~1 minute post stimulation

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Active HD-tDCSFrequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS SessionMODERATE0 Participants
Active HD-tDCSFrequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS SessionNONE19 Participants
Active HD-tDCSFrequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS SessionSEVERE0 Participants
Active HD-tDCSFrequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS SessionMILD0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS SessionSEVERE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS SessionNONE18 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS SessionMODERATE1 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS SessionMILD2 Participants
p-value: 0.488Fisher Exact
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.

Time frame: ~1 minute post stimulation

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Active HD-tDCSFrequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS SessionNONE6 Participants
Active HD-tDCSFrequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS SessionMILD12 Participants
Active HD-tDCSFrequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS SessionMODERATE1 Participants
Active HD-tDCSFrequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS SessionSEVERE0 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS SessionSEVERE1 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS SessionNONE7 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS SessionMODERATE2 Participants
Sham HD-tDCSFrequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS SessionMILD11 Participants
p-value: 0.999Fisher Exact

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026