Trial Outcomes & Findings for Patient Centered-Rehabilitation ver111090.1 (NCT NCT03034954)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

15 minutes after encoding

Results posted on

2018-08-16

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	21	21
Overall Study COMPLETED	20	21
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Machine malfunction; did not reach 3 mA	1	0

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active HD-tDCS n=19 Participants 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	Sham HD-tDCS n=21 Participants 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	Total n=40 Participants Total of all reporting groups
Age, Continuous	66.42 years STANDARD_DEVIATION 8.546 • n=19 Participants	65.38 years STANDARD_DEVIATION 10.604 • n=21 Participants	65.88 years STANDARD_DEVIATION 9.573 • n=40 Participants
Sex: Female, Male Female	11 Participants n=19 Participants	16 Participants n=21 Participants	27 Participants n=40 Participants
Sex: Female, Male Male	8 Participants n=19 Participants	5 Participants n=21 Participants	13 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=19 Participants	0 Participants n=21 Participants	0 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=19 Participants	21 Participants n=21 Participants	40 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=19 Participants	0 Participants n=21 Participants	0 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=19 Participants	0 Participants n=21 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	0 Participants n=19 Participants	1 Participants n=21 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=19 Participants	0 Participants n=21 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Black or African American	0 Participants n=19 Participants	1 Participants n=21 Participants	1 Participants n=40 Participants
Race (NIH/OMB) White	18 Participants n=19 Participants	19 Participants n=21 Participants	37 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=19 Participants	0 Participants n=21 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=19 Participants	0 Participants n=21 Participants	0 Participants n=40 Participants
Region of Enrollment United States	19 Participants n=19 Participants	21 Participants n=21 Participants	40 Participants n=40 Participants
Mini-Mental State Examination	28.58 units on a scale STANDARD_DEVIATION 1.216 • n=19 Participants • 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)	28.37 units on a scale STANDARD_DEVIATION 1.212 • n=19 Participants • 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)	28.47 units on a scale STANDARD_DEVIATION 1.202 • n=38 Participants • 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)
Education	16.82 years STANDARD_DEVIATION 1.59 • n=17 Participants • Missing data for two participants	16.48 years STANDARD_DEVIATION 2.089 • n=21 Participants • Missing data for two participants	16.63 years STANDARD_DEVIATION 1.866 • n=38 Participants • Missing data for two participants
Impedance	0.9512 quality units STANDARD_DEVIATION 0.4004 • n=19 Participants	0.8939 quality units STANDARD_DEVIATION .06314 • n=21 Participants	0.921 quality units STANDARD_DEVIATION 0.528 • n=40 Participants
Object Location Touchscreen Task (Version B) Free Recall Total Error	115.27 centimeters STANDARD_DEVIATION 44.445 • n=19 Participants	102.534 centimeters STANDARD_DEVIATION 6.835 • n=21 Participants	108.583 centimeters STANDARD_DEVIATION 7.239 • n=40 Participants
Object Location Touchscreen Task (Version B) Free Recall Average Error	7.685 centimeters STANDARD_DEVIATION 2.963 • n=19 Participants	6.835 centimeters STANDARD_DEVIATION 2.97 • n=21 Participants	7.239 centimeters STANDARD_DEVIATION 2.96 • n=40 Participants
Object Location Touchscreen Task (Version B) Free Recall Average Time to Respond	3796.361 milliseconds STANDARD_DEVIATION 1188.015 • n=19 Participants	4921.558 milliseconds STANDARD_DEVIATION 2306.631 • n=21 Participants	4387.09 milliseconds STANDARD_DEVIATION 1924.503 • n=40 Participants
Object Location Touchscreen Task (Version B) Cued Recall Total Error	74.513 centimeters STANDARD_DEVIATION 51.385 • n=19 Participants	45.055 centimeters STANDARD_DEVIATION 38.61 • n=21 Participants	59.048 centimeters STANDARD_DEVIATION 46.958 • n=40 Participants
Object Location Touchscreen Task (Version B) Cued Recall Average Error	4.971 centimeters STANDARD_DEVIATION 3.422 • n=19 Participants	3.002 centimeters STANDARD_DEVIATION 2.574 • n=21 Participants	3.937 centimeters STANDARD_DEVIATION 3.129 • n=40 Participants
Object Location Touchscreen Task (Version B) Cued Recall Average Time to Respond	3855.83 milliseconds STANDARD_DEVIATION 2452.1 • n=19 Participants	3307.879 milliseconds STANDARD_DEVIATION 1605.689 • n=21 Participants	3568.155 milliseconds STANDARD_DEVIATION 2043.063 • n=40 Participants
Object Location Touchscreen Task (Version B) Recognition Total Correct	13.11 number of correct answers STANDARD_DEVIATION 1.941 • n=19 Participants	14.05 number of correct answers STANDARD_DEVIATION 1.322 • n=21 Participants	13.6 number of correct answers STANDARD_DEVIATION 1.692 • n=40 Participants
Object Location Touchscreen Task (Version B) Recognition Average Time to Respond	3005.095 milliseconds STANDARD_DEVIATION 1807.47 • n=19 Participants	2456.063 milliseconds STANDARD_DEVIATION 1164.46 • n=21 Participants	2716.853 milliseconds STANDARD_DEVIATION 1510.062 • n=40 Participants

PRIMARY outcome

Timeframe: 15 minutes after encoding

Population: Missing data for one participant

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.

Outcome measures

Outcome measures
Measure	Active HD-tDCS n=19 Participants 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	Sham HD-tDCS n=20 Participants 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
Object Location Touchscreen Task (Version C) Free Recall Total Error	121.498 centimeters Standard Deviation 26.366	99.77 centimeters Standard Deviation 27.845

PRIMARY outcome

Timeframe: 15 minutes after encoding

Population: Missing data for one participant

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.

Outcome measures

Outcome measures
Measure	Active HD-tDCS n=19 Participants 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	Sham HD-tDCS n=20 Participants 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
Object Location Touchscreen Task (Version C) Free Recall Average Error	8.099 centimeters Standard Deviation 1.757	6.652 centimeters Standard Deviation 1.856

PRIMARY outcome

Timeframe: 15 minutes after encoding

Population: Missing data for one participant

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.

Outcome measures

Outcome measures
Measure	Active HD-tDCS n=19 Participants 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	Sham HD-tDCS n=20 Participants 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
Object Location Touchscreen Task (Version C) Free Recall Average Time to Respond	3419.878 milliseconds Standard Deviation 1690.354	3029.648 milliseconds Standard Deviation 1572.416

PRIMARY outcome

Timeframe: 15 minutes after encoding

Population: Missing data for one participant

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.

Outcome measures

Outcome measures
Measure	Active HD-tDCS n=19 Participants 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	Sham HD-tDCS n=20 Participants 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
Object Location Touchscreen Task (Version C) Cued Recall Total Error	66.806 centimeters Standard Deviation 29.303	43.775 centimeters Standard Deviation 29.32

PRIMARY outcome

Timeframe: 15 minutes after encoding

Population: Missing data for one participant

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.

Outcome measures

Outcome measures
Measure	Active HD-tDCS n=19 Participants 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	Sham HD-tDCS n=20 Participants 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
Object Location Touchscreen Task (Version C) Cued Recall Average Error	4.453 centimeters Standard Deviation 1.954	2.919 centimeters Standard Deviation 1.954

PRIMARY outcome

Timeframe: 15 minutes after encoding

Population: Missing data for one participant

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.

Outcome measures

Outcome measures
Measure	Active HD-tDCS n=19 Participants 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	Sham HD-tDCS n=20 Participants 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
Object Location Touchscreen Task (Version C) Cued Recall Average Time to Respond	3991.659 milliseconds Standard Deviation 2218.596	2666.858 milliseconds Standard Deviation 866.887

PRIMARY outcome

Timeframe: 15 minutes after encoding

Population: Missing data for one participant

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.

Outcome measures

Outcome measures
Measure	Active HD-tDCS n=19 Participants 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	Sham HD-tDCS n=20 Participants 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
Object Location Touchscreen Task (Version C) Recognition Total Correct	12.79 number of correct answers Standard Deviation 1.932	13.45 number of correct answers Standard Deviation 1.669

PRIMARY outcome

Timeframe: 15 minutes after encoding

Population: Missing data for one participant

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.

Outcome measures

Outcome measures
Measure	Active HD-tDCS n=19 Participants 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	Sham HD-tDCS n=20 Participants 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
Object Location Touchscreen Task (Version C) Recognition Average Time to Respond	2804.459 milliseconds Standard Deviation 1244.249	1903.39 milliseconds Standard Deviation 843.244

PRIMARY outcome

Timeframe: 30 minutes post-stimulation

Population: missing data for two participants

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.

Outcome measures

Outcome measures
Measure	Active HD-tDCS n=17 Participants 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	Sham HD-tDCS n=21 Participants 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
Performance (d') on a Simple Attention (0-back) Test	4.26 d' Standard Deviation .231	4.25 d' Standard Deviation .219

PRIMARY outcome

Timeframe: 30 minutes post-stimulation

Population: missing data for two participants

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.

Outcome measures

Outcome measures
Measure	Active HD-tDCS n=17 Participants 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	Sham HD-tDCS n=21 Participants 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
Performance (d') on a Working Memory (2-back) Test	3.05 d' Standard Deviation .508	2.94 d' Standard Deviation .675

PRIMARY outcome

Timeframe: 30 minutes post-stimulation

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

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.

Outcome measures

Outcome measures
Measure	Active HD-tDCS n=14 Participants 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	Sham HD-tDCS n=15 Participants 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
Performance (d') on a Working Memory (Semantic 2-back) Test	1.518 d' Standard Deviation .537	1.69 d' Standard Deviation .495

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	Active HD-tDCS n=13 Participants 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	Sham HD-tDCS n=15 Participants 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
Calculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d')	-1.130 d' Standard Deviation .629	-1.31 d' Standard Deviation .675

PRIMARY outcome

Timeframe: 30 minutes post-stimulation

Population: missing data for two participants

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.