Trial Outcomes & Findings for The Effects of Noninvasive Brain Stimulation on Physical and Mental Functioning in Older Adults (NCT NCT02436915)
NCT ID: NCT02436915
Last Updated: 2019-06-05
Results Overview
Mobility and turning will be assessed by the timed up-and-go test (TUG) (Podsiadlo \& Richardson, 1991). The participant will be seated in an armed chair. On the word "go," the subject will stand up using the arm rests if needed, walk (with assistive device if needed) around a cone placed three meters in front of the chair, return and sit down as quickly as possible. Time to complete the TUG test will be used as the outcome measure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
baseline, immediately after intervention and 2 weeks post intervention
Results posted on
2019-06-05
Participant Flow
Participant milestones
| Measure |
Real tDCS
The "real tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) at a target current intensity of 1.5 mA.
Real tDCS: Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability.
|
Sham tDCS
The "sham tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation, except current will only be applied for the first 60 seconds of each session.
Sham tDCS: For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation.
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|---|---|---|
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Overall Study
STARTED
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9
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Real tDCS
The "real tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) at a target current intensity of 1.5 mA.
Real tDCS: Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability.
|
Sham tDCS
The "sham tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation, except current will only be applied for the first 60 seconds of each session.
Sham tDCS: For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation.
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|---|---|---|
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Overall Study
Withdrawal by Subject
|
0
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1
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Baseline Characteristics
The Effects of Noninvasive Brain Stimulation on Physical and Mental Functioning in Older Adults
Baseline characteristics by cohort
| Measure |
Real tDCS
n=9 Participants
The "real tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) at a target current intensity of 1.5 mA.
Real tDCS: Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability.
|
Sham tDCS
n=10 Participants
The "sham tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation, except current will only be applied for the first 60 seconds of each session.
Sham tDCS: For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation.
|
Total
n=19 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
83.10 years
STANDARD_DEVIATION 10.36 • n=5 Participants
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78.12 years
STANDARD_DEVIATION 10.79 • n=7 Participants
|
80.46 years
STANDARD_DEVIATION 10.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
29.17 kg/m^2
STANDARD_DEVIATION 4.44 • n=5 Participants
|
31.46 kg/m^2
STANDARD_DEVIATION 5.75 • n=7 Participants
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30.38 kg/m^2
STANDARD_DEVIATION 5.15 • n=5 Participants
|
|
Gait Speed
|
0.73 m/s
STANDARD_DEVIATION 0.17 • n=5 Participants
|
0.73 m/s
STANDARD_DEVIATION 0.14 • n=7 Participants
|
0.73 m/s
STANDARD_DEVIATION 0.15 • n=5 Participants
|
|
Difference between the time to complete Trail Make Test Section B section and Section A
|
148.62 seconds
STANDARD_DEVIATION 81.64 • n=5 Participants
|
143.57 seconds
STANDARD_DEVIATION 71.96 • n=7 Participants
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145.94 seconds
STANDARD_DEVIATION 74.24 • n=5 Participants
|
|
Geriatric Depression Scale Score
|
3.00 units on a scale
STANDARD_DEVIATION 3.02 • n=5 Participants
|
4.00 units on a scale
STANDARD_DEVIATION 2.55 • n=7 Participants
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3.06 units on a scale
STANDARD_DEVIATION 2.21 • n=5 Participants
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PRIMARY outcome
Timeframe: baseline, immediately after intervention and 2 weeks post interventionPopulation: 19 participants were enrolled in the study and completed baseline assessments. One participant withdrew from the follow-up session due to illness deemed unrelated to participation. 18 participants completed all the study sessions.
Mobility and turning will be assessed by the timed up-and-go test (TUG) (Podsiadlo \& Richardson, 1991). The participant will be seated in an armed chair. On the word "go," the subject will stand up using the arm rests if needed, walk (with assistive device if needed) around a cone placed three meters in front of the chair, return and sit down as quickly as possible. Time to complete the TUG test will be used as the outcome measure.
Outcome measures
| Measure |
Real tDCS
n=8 Participants
The "real tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) at a target current intensity of 1.5 mA.
Real tDCS: Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability.
|
Sham tDCS
n=8 Participants
The "sham tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation, except current will only be applied for the first 60 seconds of each session.
Sham tDCS: For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation.
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|---|---|---|
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Percent Change From Baseline to Post Intervention on Mobility
Percent Change (Baseline to Immediate Follow Up)
|
-3.0 percent change of TUG time
Standard Deviation 17.1
|
10.4 percent change of TUG time
Standard Deviation 37.2
|
|
Percent Change From Baseline to Post Intervention on Mobility
Percent Change (Baseline to 2-Week Follow up)
|
-6.1 percent change of TUG time
Standard Deviation 17.6
|
3.4 percent change of TUG time
Standard Deviation 24.1
|
PRIMARY outcome
Timeframe: Baseline, immediately after intervention and 2 weeks post interventionPopulation: 19 participants were enrolled in the study and completed baseline assessments. One participant withdrew from the follow-up session due to illness deemed unrelated to participation. 18 participants completed all the study sessions.
The Montreal Cognitive Assessment (MoCA) score is used as the outcome measure of Global Cognition Impairment. MoCA score ranges from 0 to 30. Lower MoCA score represents poorer cognitive function (i.e., more severe Global Cognition Impairment).
Outcome measures
| Measure |
Real tDCS
n=8 Participants
The "real tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) at a target current intensity of 1.5 mA.
Real tDCS: Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability.
|
Sham tDCS
n=8 Participants
The "sham tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation, except current will only be applied for the first 60 seconds of each session.
Sham tDCS: For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation.
|
|---|---|---|
|
Percent Change From Baseline to Post Intervention on Global Cognition Impairment
Percent Change (Baseline to Immediate Follow Up)
|
7.9 percent change
Standard Deviation 16.9
|
0.1 percent change
Standard Deviation 8.2
|
|
Percent Change From Baseline to Post Intervention on Global Cognition Impairment
Percent Change (Baseline to 2-Week Follow up)
|
12.6 percent change
Standard Deviation 14.5
|
-0.4 percent change
Standard Deviation 7.8
|
PRIMARY outcome
Timeframe: baseline, immediately after intervention and 2 weeks post interventionSix 24-meter walking trials at a preferred speed are completed and each three of them are in normal or dual task condition. The GaitRite pressure mat (Havertown, PA) will be used to record bilateral foot placements and measure the walking speed. Dual task cost to walking speed is defined as the percent change of walking speed from normal walking to dual task walking. The outcome was calculated by averaging the dual task costs of the six trials.
Outcome measures
| Measure |
Real tDCS
n=8 Participants
The "real tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) at a target current intensity of 1.5 mA.
Real tDCS: Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability.
|
Sham tDCS
n=8 Participants
The "sham tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation, except current will only be applied for the first 60 seconds of each session.
Sham tDCS: For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation.
|
|---|---|---|
|
Percent Change From Baseline to Post Intervention on Dual Task Cost to Walking Speed in 24-meter Walking Test
Percent Change (Baseline to Immediate Follow Up)
|
14.9 percent change
Standard Deviation 17.3
|
3.9 percent change
Standard Deviation 14.5
|
|
Percent Change From Baseline to Post Intervention on Dual Task Cost to Walking Speed in 24-meter Walking Test
Percent Change (Baseline to 2-Week Follow up)
|
6.1 percent change
Standard Deviation 8.4
|
3.9 percent change
Standard Deviation 14.5
|
PRIMARY outcome
Timeframe: baseline, immediately after intervention and 2 weeks post interventionPostural sway speed - assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during six, 30-second trials of standing with eyes open (single task) or performing a cognitive task (dual task standing) on a stationary force platform (Kistler, Amherst, NY). Dual task cost is defined as the percent change of sway speed from single task standing to dual task standing. The outcome was obtained by averaging the dual task costs of the six trials.
Outcome measures
| Measure |
Real tDCS
n=8 Participants
The "real tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) at a target current intensity of 1.5 mA.
Real tDCS: Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability.
|
Sham tDCS
n=8 Participants
The "sham tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation, except current will only be applied for the first 60 seconds of each session.
Sham tDCS: For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation.
|
|---|---|---|
|
Percent Change From Baseline to Post Intervention on Dual Task Cost to Standing Postural Sway Speed
Percent Change (Baseline to 2-Week Follow up)
|
-11.5 percentage change
Standard Deviation 20.2
|
15.3 percentage change
Standard Deviation 30.6
|
|
Percent Change From Baseline to Post Intervention on Dual Task Cost to Standing Postural Sway Speed
Percent Change (Baseline to Immediate Follow Up)
|
-23.1 percentage change
Standard Deviation 24.5
|
16.5 percentage change
Standard Deviation 27.5
|
SECONDARY outcome
Timeframe: baseline, immediately after intervention and 2 weeks post interventionGDS total Score. The GDS total score ranges from 0 to 15. Higher GDS score represents more severe depression.
Outcome measures
| Measure |
Real tDCS
n=8 Participants
The "real tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) at a target current intensity of 1.5 mA.
Real tDCS: Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability.
|
Sham tDCS
n=8 Participants
The "sham tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation, except current will only be applied for the first 60 seconds of each session.
Sham tDCS: For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation.
|
|---|---|---|
|
Percent Change From Baseline to Post Intervention on Geriatric Depression Scale (GDS) Score
Percent Change (Baseline to Immediate Follow Up)
|
10.5 percent change
Standard Deviation 54.4
|
-12.9 percent change
Standard Deviation 72.6
|
|
Percent Change From Baseline to Post Intervention on Geriatric Depression Scale (GDS) Score
Percent Change (Baseline to 2-Week Follow up)
|
27.3 percent change
Standard Deviation 92.5
|
-2.4 percent change
Standard Deviation 76.2
|
SECONDARY outcome
Timeframe: baseline, immediately after intervention and 2 weeks post interventionTime to complete Trail Making Test part B minus time to complete TMT part A. Slower time to complete TMT-B as compared to TMT-A represents poorer executive function.
Outcome measures
| Measure |
Real tDCS
n=8 Participants
The "real tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) at a target current intensity of 1.5 mA.
Real tDCS: Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability.
|
Sham tDCS
n=8 Participants
The "sham tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation, except current will only be applied for the first 60 seconds of each session.
Sham tDCS: For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation.
|
|---|---|---|
|
Percent Change From Baseline to Post Intervention on Trial Making Test (TMT)
Percent Change (Baseline to Immediate Follow Up)
|
-65.8 percent change
Standard Deviation 25.2
|
-17.1 percent change
Standard Deviation 49.5
|
|
Percent Change From Baseline to Post Intervention on Trial Making Test (TMT)
Percent Change (Baseline to 2-Week Follow up)
|
-38.1 percent change
Standard Deviation 34.8
|
-17.2 percent change
Standard Deviation 58.9
|
SECONDARY outcome
Timeframe: baseline, immediately after intervention and 2 weeks post interventionPostural sway speed - assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during six, 30-second trials of standing with eyes open (single task) or performing a cognitive task (dual task standing) on a stationary force platform (Kistler, Amherst, NY). Dual task cost is defined as the percent change of sway area from single task standing to dual task standing. The outcome was calculated by averaging the dual task costs of the six trials.
Outcome measures
| Measure |
Real tDCS
n=8 Participants
The "real tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) at a target current intensity of 1.5 mA.
Real tDCS: Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability.
|
Sham tDCS
n=8 Participants
The "sham tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation, except current will only be applied for the first 60 seconds of each session.
Sham tDCS: For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation.
|
|---|---|---|
|
Percent Change From Baseline to Post Intervention on Dual-task Cost to Standing Sway Area
Percent Change (Baseline to Immediate Follow Up)
|
-32.9 percentage change
Standard Deviation 43.6
|
51.1 percentage change
Standard Deviation 54.2
|
|
Percent Change From Baseline to Post Intervention on Dual-task Cost to Standing Sway Area
Percent Change (Baseline to 2-Week Follow up)
|
-34.4 percentage change
Standard Deviation 24.3
|
211.8 percentage change
Standard Deviation 153.2
|
SECONDARY outcome
Timeframe: baseline, immediately after intervention and 2 weeks post interventionSix 24-meter walking trials at a preferred speed are completed and each three of them are in normal or dual task condition. The GaitRite pressure mat (Havertown, PA) will be used to record bilateral foot placements and measure the walking speed. Dual task cost to stride time is defined as the percent change of stride time from normal walking to dual task walking.The outcome was calculated by averaging the dual task costs of the six trials.
Outcome measures
| Measure |
Real tDCS
n=8 Participants
The "real tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) at a target current intensity of 1.5 mA.
Real tDCS: Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability.
|
Sham tDCS
n=8 Participants
The "sham tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation, except current will only be applied for the first 60 seconds of each session.
Sham tDCS: For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation.
|
|---|---|---|
|
Percent Change From Baseline to Post Intervention on Dual Task Cost to Stride Time in 24-meter Walking Test
Percent Change (Baseline to Immediate Follow Up)
|
-25.7 percent change
Standard Deviation 38.4
|
83.8 percent change
Standard Deviation 175.5
|
|
Percent Change From Baseline to Post Intervention on Dual Task Cost to Stride Time in 24-meter Walking Test
Percent Change (Baseline to 2-Week Follow up)
|
-16.3 percent change
Standard Deviation 37.1
|
57.0 percent change
Standard Deviation 136.9
|
Adverse Events
Real tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Real tDCS
n=8 participants at risk
The "real tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) at a target current intensity of 1.5 mA.
Real tDCS: Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability.
|
Sham tDCS
n=9 participants at risk
The "sham tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation, except current will only be applied for the first 60 seconds of each session.
Sham tDCS: For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Injurious Fall
|
12.5%
1/8 • Number of events 1 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
Additional Information
Brad Manor
Institute for Aging Research, Hebrew SeniorLife
Phone: 617-971-5332
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place