Trial Outcomes & Findings for tDCS in Elderly Fallers Study (NCT NCT03814304)

NCT ID: NCT03814304

Last Updated: 2026-07-28

Results Overview

This metric will assess the change from baseline in the degree to which performing a secondary cognitive task diminishes gait speed. The dual-task cost (DTC) to gait speed is calculated by (dual-task gait speed-single-task gait speed)/single-task gait speed \*100. Greater reduction in DTC to gait speed from baseline to post intervention indicates better performance.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

99 participants

Primary outcome timeframe

3-day follow-up; 3-month follow-up; 6-month follow-up

Results posted on

2026-07-28

Participant Flow

Participant milestones

Participant milestones
Measure
tDCS
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Overall Study
STARTED
50
49
Overall Study
COMPLETED
48
43
Overall Study
NOT COMPLETED
2
6

Reasons for withdrawal

Reasons for withdrawal
Measure
tDCS
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Overall Study
Lost to Follow-up
1
3
Overall Study
Adverse Event
1
3

Baseline Characteristics

tDCS in Elderly Fallers Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
tDCS
n=48 Participants
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=43 Participants
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Total
n=91 Participants
Total of all reporting groups
Age, Continuous
80 years
STANDARD_DEVIATION 7 • n=20 Participants
78 years
STANDARD_DEVIATION 7 • n=20 Participants
79 years
STANDARD_DEVIATION 7 • n=40 Participants
Sex: Female, Male
Female
30 Participants
n=20 Participants
27 Participants
n=20 Participants
57 Participants
n=40 Participants
Sex: Female, Male
Male
18 Participants
n=20 Participants
16 Participants
n=20 Participants
34 Participants
n=40 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Race (NIH/OMB)
Asian
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Race (NIH/OMB)
Black or African American
6 Participants
n=20 Participants
2 Participants
n=20 Participants
8 Participants
n=40 Participants
Race (NIH/OMB)
White
41 Participants
n=20 Participants
41 Participants
n=20 Participants
82 Participants
n=40 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=20 Participants
0 Participants
n=20 Participants
1 Participants
n=40 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
BMI
30 kg/m^2
STANDARD_DEVIATION 6 • n=20 Participants
29 kg/m^2
STANDARD_DEVIATION 6 • n=20 Participants
29 kg/m^2
STANDARD_DEVIATION 6 • n=40 Participants
Clinical Dementia Rating (CDR)
CDR=0
38 Participants
n=20 Participants
29 Participants
n=20 Participants
67 Participants
n=40 Participants
Clinical Dementia Rating (CDR)
CDR=0.5
10 Participants
n=20 Participants
14 Participants
n=20 Participants
24 Participants
n=40 Participants

PRIMARY outcome

Timeframe: 3-day follow-up; 3-month follow-up; 6-month follow-up

This metric will assess the change from baseline in the degree to which performing a secondary cognitive task diminishes gait speed. The dual-task cost (DTC) to gait speed is calculated by (dual-task gait speed-single-task gait speed)/single-task gait speed \*100. Greater reduction in DTC to gait speed from baseline to post intervention indicates better performance.

Outcome measures

Outcome measures
Measure
tDCS
n=48 Participants
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=43 Participants
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Change From Baseline in the Dual Task Cost to Gait Speed
Change from baseline to 3-day follow-up
-4.06 percentage
Standard Deviation 6.54
-1.63 percentage
Standard Deviation 6.44
Change From Baseline in the Dual Task Cost to Gait Speed
Change from baseline to 3-month follow-up
-3.94 percentage
Standard Deviation 7.59
-0.37 percentage
Standard Deviation 6.14
Change From Baseline in the Dual Task Cost to Gait Speed
Change from baseline to 6-month follow-up
-3.72 percentage
Standard Deviation 5.53
0.61 percentage
Standard Deviation 6.18

SECONDARY outcome

Timeframe: 3-day follow-up; 3-month follow-up; 6-month follow-up

This metric will assess the change from baseline in fear of falling. Participants will rate, on a 4-point Likert scale, fear of falling when performing 16 activities. Scores are added up to calculate a total score that ranges from 16 to 64. The cut-point for high fear of falling is defined as scores \>23 for this 16-item scale. The decrease of this scale indicates lower fear of falling.

Outcome measures

Outcome measures
Measure
tDCS
n=48 Participants
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=43 Participants
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Change From Baseline in Falls Efficacy Scale
Change from baseline to 3-month follow-up
0.16 Scores on a scale
Standard Deviation 5.26
-0.25 Scores on a scale
Standard Deviation 3.45
Change From Baseline in Falls Efficacy Scale
Change from baseline to 6-month follow-up
-0.34 Scores on a scale
Standard Deviation 3.39
0.92 Scores on a scale
Standard Deviation 4.74
Change From Baseline in Falls Efficacy Scale
Change from baseline to 3-day follow-up
-1.15 Scores on a scale
Standard Deviation 4.23
-0.54 Scores on a scale
Standard Deviation 4.04

SECONDARY outcome

Timeframe: 3-day follow-up; 3-month follow-up; 6-month follow-up

This metric, Montreal Cognitive Assessment (MoCA), is a standardized screening measure of global cognitive function, including attention, executive function, memory, language, visuospatial abilities, abstraction, calculation, and orientation. Total scores range from 0 to 30, with higher scores indicating better cognitive performance.

Outcome measures

Outcome measures
Measure
tDCS
n=48 Participants
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=43 Participants
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score
Change from baseline to 3-day follow-up
1.07 scores on a scale
Standard Deviation 2.34
0.02 scores on a scale
Standard Deviation 2.41
Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score
Change from baseline to 3-month follow-up
0.55 scores on a scale
Standard Deviation 2.63
-0.18 scores on a scale
Standard Deviation 2.01
Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score
Change from baseline to 6-month follow-up
0.61 scores on a scale
Standard Deviation 2.36
-0.03 scores on a scale
Standard Deviation 2.27

SECONDARY outcome

Timeframe: 3-day follow-up; 3-month follow-up; 6-month follow-up

This metric, the Short Physical Performance Battery (SPPB), is a standardized measure of lower-extremity physical function based on standing balance, usual-pace walking speed, and repeated chair stands. Each component is scored from 0 to 4, and the component scores are summed to produce a total score ranging from 0 to 12. Higher scores indicate better lower-extremity physical function.

Outcome measures

Outcome measures
Measure
tDCS
n=48 Participants
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=43 Participants
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Change From Baseline in Short Physical Performance Battery (SPPB)
Change from baseline to 3-day follow-up
0.18 scores on a scale
Standard Deviation 0.31
0.10 scores on a scale
Standard Deviation 0.15
Change From Baseline in Short Physical Performance Battery (SPPB)
Change from baseline to 3-month follow-up
0.09 scores on a scale
Standard Deviation 0.26
0.04 scores on a scale
Standard Deviation 0.23
Change From Baseline in Short Physical Performance Battery (SPPB)
Change from baseline to 6-month follow-up
0.14 scores on a scale
Standard Deviation 0.24
0.08 scores on a scale
Standard Deviation 0.04

SECONDARY outcome

Timeframe: 3-day follow-up; 3-month follow-up; 6-month follow-up

This metric will assess the change from baseline in the degree to which performing a secondary cognitive task diminishes the control of gait. The dual-task cost (DTC) to stride time variability (STV) is calculated by (dual-task STV - single-task STV)/single-task STV \*100. Greater reduction in DTC to STV from baseline to post intervention indicates better performance.

Outcome measures

Outcome measures
Measure
tDCS
n=48 Participants
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=43 Participants
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Change From Baseline in the Dual Task Cost to Stride Time Variability
Change from baseline to 3-month follow-up
-9.31 percentage
Standard Deviation 61.91
-7.2 percentage
Standard Deviation 36.98
Change From Baseline in the Dual Task Cost to Stride Time Variability
Change from baseline to 6-month follow-up
-10.49 percentage
Standard Deviation 65.88
-2.44 percentage
Standard Deviation 41.16
Change From Baseline in the Dual Task Cost to Stride Time Variability
Change from baseline to 3-day follow-up
-15.14 percentage
Standard Deviation 64.97
-4.69 percentage
Standard Deviation 31.74

SECONDARY outcome

Timeframe: 3-day follow-up; 3-month follow-up; 6-month follow-up

This metric will assess the change from baseline in the degree to which walking diminishes the ability to perform a cognitive task. The dual-task cost (DTC) to the correct rate of serial subtraction (correct rate) is calculated by (dual-task correct rate - single-task correct rate)/single-task correct rate \*100. Greater reduction in DTC to correct rate from baseline to post intervention indicates better performance.

Outcome measures

Outcome measures
Measure
tDCS
n=48 Participants
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=43 Participants
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Change From Baseline in the Dual Task Cost to the Correct Rate of Serial Subtraction
Change from baseline to 3-month follow-up
11.61 percentage
Standard Deviation 50.32
0.59 percentage
Standard Deviation 11.13
Change From Baseline in the Dual Task Cost to the Correct Rate of Serial Subtraction
Change from baseline to 6-month follow-up
8.73 percentage
Standard Deviation 49.79
1.83 percentage
Standard Deviation 16.78
Change From Baseline in the Dual Task Cost to the Correct Rate of Serial Subtraction
Change from baseline to 3-day follow-up
6.94 percentage
Standard Deviation 53.90
1.07 percentage
Standard Deviation 15.27

SECONDARY outcome

Timeframe: 3-day follow-up; 3-month follow-up; 6-month follow-up

The Trail Making Test (TMT) assesses visual attention, processing speed, cognitive flexibility, and executive function. In Part A, participants connect numbered targets in sequential order. In Part B, participants alternate between numbers and letters in sequential order. Completion time is recorded in seconds, with a maximum allowable completion time of 300 seconds. The "TMT B - A" score was calculated by subtracting the time required to complete Part A from the time required to complete Part B. This derived score reflects the additional executive-function and set-shifting demands of Part B while accounting for visual scanning and motor speed. Lower values indicate better performance.

Outcome measures

Outcome measures
Measure
tDCS
n=48 Participants
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=43 Participants
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Change From Baseline in Trail Making Test B - A
Change from baseline to 3-day follow-up
-6.62 second
Standard Deviation 34.69
-1.38 second
Standard Deviation 32.83
Change From Baseline in Trail Making Test B - A
Change from baseline to 6-month follow-up
-2.66 second
Standard Deviation 33.49
-0.03 second
Standard Deviation 2.27
Change From Baseline in Trail Making Test B - A
Change from baseline to 3-month follow-up
-0.35 second
Standard Deviation 39.59
-8.29 second
Standard Deviation 32.71

SECONDARY outcome

Timeframe: 3-day follow-up; 3-month follow-up; 6-month follow-up

This metric, time to complete Timed-Up-and-Go (TUG) task, is a standardized measure of functional mobility and balance. It records the time, in seconds, required for a participant to stand up from a chair, walk straightly, turn around, walk back straightly, and sit down. Faster TUG time indicates better mobility.

Outcome measures

Outcome measures
Measure
tDCS
n=48 Participants
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=43 Participants
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Change From Baseline in Timed-Up-and-Go (TUG) Time
Change from baseline to 3-day follow-up
0.17 second
Standard Deviation 1.58
-0.65 second
Standard Deviation 3.59
Change From Baseline in Timed-Up-and-Go (TUG) Time
Change from baseline to 3-month follow-up
0.07 second
Standard Deviation 3.13
-0.95 second
Standard Deviation 3.00
Change From Baseline in Timed-Up-and-Go (TUG) Time
Change from baseline to 6-month follow-up
-1.40 second
Standard Deviation 5.09
-0.99 second
Standard Deviation 4.09

SECONDARY outcome

Timeframe: 3-day follow-up; 3-month follow-up; 6-month follow-up

This test will assess the change from baseline in working memory. The score of Digit Span ranges from 0 to 32. Higher total scores indicate better working memory performance. Change from baseline was calculated as the follow-up total score minus the baseline total score. Possible change scores range from -32 to 32. Positive values indicate improvement, negative values indicate worsening, and a value of 0 indicates no change.

Outcome measures

Outcome measures
Measure
tDCS
n=48 Participants
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=43 Participants
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Change From Baseline in Digit Span
Change from baseline to 3-day follow-up
0.68 point
Standard Deviation 1.03
-0.67 point
Standard Deviation 3.66
Change From Baseline in Digit Span
Change from baseline to 3-month follow-up
0.91 point
Standard Deviation 4.59
-0.77 point
Standard Deviation 5.08
Change From Baseline in Digit Span
Change from baseline to 6-month follow-up
0.74 point
Standard Deviation 3.66
-0.56 point
Standard Deviation 5.01

SECONDARY outcome

Timeframe: 3-day follow-up; 3-month follow-up; 6-month follow-up

This common test will assess the change from baseline in word retrieval. Higher scores indicate better verbal fluency performance.

Outcome measures

Outcome measures
Measure
tDCS
n=48 Participants
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=43 Participants
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Change From Baseline in Category and Phonemic Fluency Test
Change from baseline to 3-day follow-up
0.29 number of words
Standard Deviation 5.07
-0.55 number of words
Standard Deviation 4.05
Change From Baseline in Category and Phonemic Fluency Test
Change from baseline to 3-month follow-up
1.35 number of words
Standard Deviation 4.89
-0.35 number of words
Standard Deviation 3.46
Change From Baseline in Category and Phonemic Fluency Test
Change from baseline to 6-month follow-up
1.80 number of words
Standard Deviation 6.58
0.92 number of words
Standard Deviation 4.74

SECONDARY outcome

Timeframe: 3-day follow-up; 3-month follow-up; 6-month follow-up

This common test will assess the change from baseline in s verbal learning and episodic memory. The score ranges from 0% to 100%, with higher percentages indicating better retention of previously learned verbal information.

Outcome measures

Outcome measures
Measure
tDCS
n=48 Participants
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=43 Participants
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Change From Baseline in Retention Rate in Hopkins Verbal Learning Test
Change from baseline to 3-day follow-up
-1.68 Percentage of words correctly recalled
Standard Deviation 24.98
-0.84 Percentage of words correctly recalled
Standard Deviation 24.42
Change From Baseline in Retention Rate in Hopkins Verbal Learning Test
Change from baseline to 6-month follow-up
3.18 Percentage of words correctly recalled
Standard Deviation 19.14
2.12 Percentage of words correctly recalled
Standard Deviation 20.86
Change From Baseline in Retention Rate in Hopkins Verbal Learning Test
Change from baseline to 3-month follow-up
4.42 Percentage of words correctly recalled
Standard Deviation 30.89
-4.04 Percentage of words correctly recalled
Standard Deviation 19.25

SECONDARY outcome

Timeframe: 3-day follow-up; 3-month follow-up; 6-month follow-up

The 12-Item Short Form Health Survey Physical Component Summary (SF-12 PCS) is a patient-reported measure of physical health and physical health-related quality of life. Scores range from 0 to 100, with higher scores indicating better physical health and functioning.

Outcome measures

Outcome measures
Measure
tDCS
n=48 Participants
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=43 Participants
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Change From Baseline in Short Form (SF) - 12-physical
Change from baseline to 6-month follow-up
1.15 scores on a scale
Standard Deviation 8.68
-0.84 scores on a scale
Standard Deviation 5.54
Change From Baseline in Short Form (SF) - 12-physical
Change from baseline to 3-month follow-up
2.34 scores on a scale
Standard Deviation 8.30
-0.57 scores on a scale
Standard Deviation 8.37
Change From Baseline in Short Form (SF) - 12-physical
Change from baseline to 3-day follow-up
2.97 scores on a scale
Standard Deviation 8.35
-1.56 scores on a scale
Standard Deviation 5.21

SECONDARY outcome

Timeframe: 3-day follow-up; 3-month follow-up; 6-month follow-up

This questionnaire measures the changes in mental-health-related quality of life from baseline to post-intervention follow-ups. The 12-Item Short Form Health Survey Mental Component Summary (SF-12 MCS) is a patient-reported measure of mental health and mental health-related quality of life. Scores range from 0 to 100, with higher scores indicating better mental health and functioning.

Outcome measures

Outcome measures
Measure
tDCS
n=48 Participants
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=43 Participants
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Change From Baseline in Short Form (SF)-12-mental
Change from baseline to 3-day follow-up
0.53 scores on a scale
Standard Deviation 6.04
-0.39 scores on a scale
Standard Deviation 5.92
Change From Baseline in Short Form (SF)-12-mental
Change from baseline to 3-month follow-up
-0.16 scores on a scale
Standard Deviation 7.98
-1.36 scores on a scale
Standard Deviation 8.19
Change From Baseline in Short Form (SF)-12-mental
Change from baseline to 6-month follow-up
0.96 scores on a scale
Standard Deviation 9.87
0.24 scores on a scale
Standard Deviation 8.70

SECONDARY outcome

Timeframe: 3-day follow-up; 3-month follow-up; 6-month follow-up

This measure the change in gait speed when walking in dual task condition from baseline to post-intervention follow-ups. Faster speed indicates better gait performance.

Outcome measures

Outcome measures
Measure
tDCS
n=48 Participants
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=43 Participants
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Change From Baseline in Dual Task Gait Speed
Change from baseline to 3-month follow-up
0.047 m/s
Standard Deviation 0.097
0.014 m/s
Standard Deviation 0.069
Change From Baseline in Dual Task Gait Speed
Change from baseline to 6-month follow-up
0.055 m/s
Standard Deviation 0.086
0.002 m/s
Standard Deviation 0.111
Change From Baseline in Dual Task Gait Speed
Change from baseline to 3-day follow-up
0.038 m/s
Standard Deviation 0.084
-0.023 m/s
Standard Deviation 0.165

SECONDARY outcome

Timeframe: 3-day follow-up; 3-month follow-up; 6-month follow-up

This outcome measures the change in gait stride time variability (STV) when walking in dual task condition from baseline to post-intervention follow-ups. Lower STV indicates better gait performance.

Outcome measures

Outcome measures
Measure
tDCS
n=48 Participants
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=43 Participants
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Change From Baseline in Dual Task Gait Stride Time Variability
Change from baseline to 3-day follow-up
-0.009 second
Standard Deviation 0.027
-0.005 second
Standard Deviation 0.017
Change From Baseline in Dual Task Gait Stride Time Variability
Change from baseline to 3-month follow-up
-0.013 second
Standard Deviation 0.023
-0.006 second
Standard Deviation 0.016
Change From Baseline in Dual Task Gait Stride Time Variability
Change from baseline to 6-month follow-up
-0.015 second
Standard Deviation 0.025
-0.004 second
Standard Deviation 0.019

SECONDARY outcome

Timeframe: 3-day follow-up; 3-month follow-up; 6-month follow-up

The outcome measures the change in gait speed when walking in single task condition from baseline to post-intervention follow-ups. faster gait speed indicates better gait performance.

Outcome measures

Outcome measures
Measure
tDCS
n=48 Participants
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=43 Participants
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Changes From Baseline in Gait Speed in Single Task Condition
Change from baseline to 3-day follow-up
0.014 m/s
Standard Deviation 0.079
-0.004 m/s
Standard Deviation 0.075
Changes From Baseline in Gait Speed in Single Task Condition
Change from baseline to 3-month follow-up
0.006 m/s
Standard Deviation 0.104
-0.002 m/s
Standard Deviation 0.079
Changes From Baseline in Gait Speed in Single Task Condition
Change from baseline to 6-month follow-up
0.014 m/s
Standard Deviation 0.098
-0.004 m/s
Standard Deviation 0.111

SECONDARY outcome

Timeframe: 3-day follow-up; 3-month follow-up; 6-month follow-up

This outcome measures the changes in gait stride time variability (STV) when walking in single task condition from baseline to post-intervention follow-ups. Lower STV indicates better gait performance.

Outcome measures

Outcome measures
Measure
tDCS
n=48 Participants
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=43 Participants
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Changes From Baseline in Gait Stride Time Variability in Single Task Condition
Change from baseline to 3-day follow-up
-0.001 second
Standard Deviation 0.011
0 second
Standard Deviation 0.008
Changes From Baseline in Gait Stride Time Variability in Single Task Condition
Change from baseline to 3-month follow-up
-0.001 second
Standard Deviation 0.012
-0.001 second
Standard Deviation 0.011
Changes From Baseline in Gait Stride Time Variability in Single Task Condition
Change from baseline to 6-month follow-up
-0.005 second
Standard Deviation 0.01
0 second
Standard Deviation 0.013

Adverse Events

tDCS

Serious events: 12 serious events
Other events: 45 other events
Deaths: 1 deaths

Active-Sham

Serious events: 7 serious events
Other events: 36 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
tDCS
n=50 participants at risk
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=49 participants at risk
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Cardiac disorders
Atrial fibrillation
2.0%
1/50 • Number of events 2 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
0.00%
0/49 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
General disorders
Death
2.0%
1/50 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
0.00%
0/49 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Infections and infestations
COVID-19
2.0%
1/50 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
0.00%
0/49 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Infections and infestations
Gastroenteritis paracolon bacillus
2.0%
1/50 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
0.00%
0/49 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Infections and infestations
Influenza
2.0%
1/50 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
0.00%
0/49 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Injury, poisoning and procedural complications
Fall
2.0%
1/50 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
2.0%
1/49 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Injury, poisoning and procedural complications
Hip fracture
2.0%
1/50 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
2.0%
1/49 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Injury, poisoning and procedural complications
Muscle strain
2.0%
1/50 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
0.00%
0/49 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Nervous system disorders
Headache
0.00%
0/50 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
2.0%
1/49 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Nervous system disorders
Transient ischaemic attack
0.00%
0/50 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
2.0%
1/49 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Psychiatric disorders
Suicidal ideation
2.0%
1/50 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
4.1%
2/49 • Number of events 4 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Respiratory, thoracic and mediastinal disorders
Dyspnoea
2.0%
1/50 • Number of events 2 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
0.00%
0/49 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
2.0%
1/50 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
0.00%
0/49 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Surgical and medical procedures
Carotid endarterectomy
2.0%
1/50 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
0.00%
0/49 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Surgical and medical procedures
Proctectomy
0.00%
0/50 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
2.0%
1/49 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Vascular disorders
Hypotension
2.0%
1/50 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
0.00%
0/49 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).

Other adverse events

Other adverse events
Measure
tDCS
n=50 participants at risk
tDCS: This intervention is designed to facilitate the excitability of the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
Active-Sham
n=49 participants at risk
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.
Musculoskeletal and connective tissue disorders
Arthralgia
14.0%
7/50 • Number of events 12 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
8.2%
4/49 • Number of events 4 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Musculoskeletal and connective tissue disorders
Back pain
10.0%
5/50 • Number of events 7 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
2.0%
1/49 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
General disorders
Balance disorder
8.0%
4/50 • Number of events 6 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
4.1%
2/49 • Number of events 3 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Infections and infestations
COVID-19
14.0%
7/50 • Number of events 7 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
12.2%
6/49 • Number of events 6 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Gastrointestinal disorders
Diarrhea
4.0%
2/50 • Number of events 2 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
8.2%
4/49 • Number of events 4 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Nervous system disorders
Dizziness
8.0%
4/50 • Number of events 4 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
6.1%
3/49 • Number of events 5 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Injury, poisoning and procedural complications
Fall
68.0%
34/50 • Number of events 113 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
55.1%
27/49 • Number of events 123 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Nervous system disorders
Headache
8.0%
4/50 • Number of events 5 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
8.2%
4/49 • Number of events 12 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Infections and infestations
Nasopharyngitis
10.0%
5/50 • Number of events 6 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
6.1%
3/49 • Number of events 3 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Gastrointestinal disorders
Nausea
6.0%
3/50 • Number of events 7 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
2.0%
1/49 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Musculoskeletal and connective tissue disorders
Pain in extremity
8.0%
4/50 • Number of events 4 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
2.0%
1/49 • Number of events 1 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Eye disorders
Photopsia
6.0%
3/50 • Number of events 5 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
0.00%
0/49 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
Infections and infestations
Pneumonia
6.0%
3/50 • Number of events 3 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).
0.00%
0/49 • A total of 7 months from randomization/start of intervention through final follow-up (approximately 6 months after intervention).

Additional Information

Brad Manor

Hebrew SeniorLife

Phone: 6179715332

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place