Trial Outcomes & Findings for Combining tDCS and Neurorehabilitation to Treat Age-related Deficits of Mobility and Cognition: UPfront Walking Study (NCT NCT03122236)
NCT ID: NCT03122236
Last Updated: 2024-06-14
Results Overview
Time to complete a walking course at usual pace. The course is 15 feet in length and arranged as a Figure-8 pattern.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Change (value at 6 weeks minus value at baseline)
Results posted on
2024-06-14
Participant Flow
Participant milestones
| Measure |
Complex Walking With Active tDCS
Neurorehabilitation of Complex Walking and Active Transcranial Direct Current Stimulation (Active tDCS)
Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs.
Acive Transcranial Direct Current Stimulation (Active tDCS): tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits.
|
Complex Walking With Sham tDCS
Neurorehabilitation of Complex Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS)
Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs.
Sham Transcranial Direct Current Stimulation (Sham tDCS): Sham tDCS is a placebo to Active tDCS.
|
Standard Walking With Sham tDCS
Neurorehabilitation of Standard Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS)
Neurorehabilitation of Standard Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of standard walking will focus on the use of typical steady state walking.
Sham Transcranial Direct Current Stimulation (Sham tDCS): Sham tDCS is a placebo to Active tDCS.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
7
|
|
Overall Study
COMPLETED
|
7
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combining tDCS and Neurorehabilitation to Treat Age-related Deficits of Mobility and Cognition: UPfront Walking Study
Baseline characteristics by cohort
| Measure |
Complex Walking With Active tDCS
n=7 Participants
Neurorehabilitation of Complex Walking and Transcranial Direct Current Stimulation (tDCS) dosage B
Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs.
Active Transcranial Direct Current Stimulation (Active tDCS): tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits.
|
Complex Walking With tDCS Dosage A
n=6 Participants
Neurorehabilitation of Complex Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS)
Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs.
Sham Transcranial Direct Current Stimulation (tDCS): Sham tDCS is a placebo to Active tDCS
|
Standard Walking With tDCS Dosage A
n=7 Participants
Neurorehabilitation of Standard Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS)
Neurorehabilitation of Standard Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of standard walking will focus on the use of typical steady state walking.
Sham Transcranial Direct Current Stimulation (tDCS): Sham tDCS is a placebo to Active tDCS
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
75.4 years
STANDARD_DEVIATION 5.8 • n=99 Participants
|
70.6 years
STANDARD_DEVIATION 5.2 • n=107 Participants
|
73.7 years
STANDARD_DEVIATION 7.6 • n=206 Participants
|
73.2 years
STANDARD_DEVIATION 6.03 • n=7 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Typical Walking Speed
|
0.94 meters per second
STANDARD_DEVIATION 0.18 • n=99 Participants
|
0.95 meters per second
STANDARD_DEVIATION 0.15 • n=107 Participants
|
0.97 meters per second
STANDARD_DEVIATION 0.12 • n=206 Participants
|
0.95 meters per second
STANDARD_DEVIATION 0.16 • n=7 Participants
|
PRIMARY outcome
Timeframe: Change (value at 6 weeks minus value at baseline)Time to complete a walking course at usual pace. The course is 15 feet in length and arranged as a Figure-8 pattern.
Outcome measures
| Measure |
Complex Walking With Active tDCS
n=7 Participants
Neurorehabilitation of Complex Walking and Transcranial Direct Current Stimulation (tDCS) dosage B
Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs.
Transcranial Direct Current Stimulation (tDCS) dosage B: tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits.
|
Complex Walking With Sham tDCS
n=5 Participants
Neurorehabilitation of Complex Walking and Transcranial Direct Current Stimulation (tDCS) dosage A
Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs.
Transcranial Direct Current Stimulation (tDCS) dosage A: tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits.
|
Standard Walking With Sham tDCS
n=6 Participants
Neurorehabilitation of Standard Walking and Transcranial Direct Current Stimulation (tDCS) dosage A
Neurorehabilitation of Standard Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of standard walking will focus on the use of typical steady state walking.
Transcranial Direct Current Stimulation (tDCS) dosage A: tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits.
|
|---|---|---|---|
|
Mobility: Figure-of-eight Walking Test (Figure-8 Walk Test)
|
10.57 seconds
Standard Deviation 1.93
|
9.58 seconds
Standard Deviation 1.42
|
11.00 seconds
Standard Deviation 2.00
|
SECONDARY outcome
Timeframe: Change (value at 6 weeks minus value at baseline)EXAMINER is an acronym for "Executive Abilities:Measures and Instruments for Neurobehavioral Evaluation and Research. EXAMINER is a battery of assessments that tests 7 domains of executive function separately and as a composite score. The composite score is based on Item Response Theory (logistic modeling) and ranges from a minimum value of -4 to a maximum value of 4. Higher scores indicate better performance.
Outcome measures
| Measure |
Complex Walking With Active tDCS
n=7 Participants
Neurorehabilitation of Complex Walking and Transcranial Direct Current Stimulation (tDCS) dosage B
Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs.
Transcranial Direct Current Stimulation (tDCS) dosage B: tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits.
|
Complex Walking With Sham tDCS
n=5 Participants
Neurorehabilitation of Complex Walking and Transcranial Direct Current Stimulation (tDCS) dosage A
Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs.
Transcranial Direct Current Stimulation (tDCS) dosage A: tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits.
|
Standard Walking With Sham tDCS
n=6 Participants
Neurorehabilitation of Standard Walking and Transcranial Direct Current Stimulation (tDCS) dosage A
Neurorehabilitation of Standard Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of standard walking will focus on the use of typical steady state walking.
Transcranial Direct Current Stimulation (tDCS) dosage A: tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits.
|
|---|---|---|---|
|
Cognitive Composite Executive Score on EXAMINER Battery
|
-0.19 units on a scale
Standard Deviation 0.74
|
0.29 units on a scale
Standard Deviation 0.22
|
0.03 units on a scale
Standard Deviation 0.96
|
Adverse Events
Complex Walking With Active tDCS
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Complex Walking With Sham tDCS
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Standard Walking With Sham tDCS
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Complex Walking With Active tDCS
n=7 participants at risk
Neurorehabilitation of Complex Walking and Transcranial Direct Current Stimulation (tDCS) dosage B
Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs.
Active Transcranial Direct Current Stimulation (Active tDCS): tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits.
|
Complex Walking With Sham tDCS
n=6 participants at risk
Neurorehabilitation of Complex Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS)
Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs.
Sham Transcranial Direct Current Stimulation (tDCS): Sham tDCS is a placebo to Active tDCS
|
Standard Walking With Sham tDCS
n=7 participants at risk
Neurorehabilitation of Standard Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS)
Neurorehabilitation of Standard Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of standard walking will focus on the use of typical steady state walking.
Sham Transcranial Direct Current Stimulation (tDCS): Sham tDCS is a placebo to Active tDCS
|
|---|---|---|---|
|
Renal and urinary disorders
kidney stones
|
14.3%
1/7 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/7 • 6 weeks
|
Other adverse events
| Measure |
Complex Walking With Active tDCS
n=7 participants at risk
Neurorehabilitation of Complex Walking and Transcranial Direct Current Stimulation (tDCS) dosage B
Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs.
Active Transcranial Direct Current Stimulation (Active tDCS): tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the "activity-dependent neuroplasticity" that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits.
|
Complex Walking With Sham tDCS
n=6 participants at risk
Neurorehabilitation of Complex Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS)
Neurorehabilitation of Complex Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs.
Sham Transcranial Direct Current Stimulation (tDCS): Sham tDCS is a placebo to Active tDCS
|
Standard Walking With Sham tDCS
n=7 participants at risk
Neurorehabilitation of Standard Walking and Sham Transcranial Direct Current Stimulation (Sham tDCS)
Neurorehabilitation of Standard Walking: Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of standard walking will focus on the use of typical steady state walking.
Sham Transcranial Direct Current Stimulation (tDCS): Sham tDCS is a placebo to Active tDCS
|
|---|---|---|---|
|
General disorders
Falling (no injury)
|
14.3%
1/7 • 6 weeks
|
33.3%
2/6 • 6 weeks
|
28.6%
2/7 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place