The objective of this study is to determine if a four-week, 20-session intervention of personalized transcranial direct current stimulation (tDCS), as compared to sham intervention, improves dual task standing and walking performance (Aim 1), as well as other physical (Aim 2) and cognitive (Aim 3) factors on the causal pathway to falls, in older adults who report two or more falls within the past year and fear of falling again in the future, yet who do not have any acute or over neurological or musculoskeletal condition. Primary endpoints will include the "dual task" costs to gait speed when walking and postural sway speed when standing, as induced by performing a serial subtraction cognitive task (i.e., \[(speeddual task - speedsingle task) / speedsingle task) X 100\] (Aim 1), the Short Physical Performance Battery (Aim 2), and the Trail Making Test (Part B minus Part A) (AIM 3). Secondary endpoints will include the dual task cost to serial subtraction performance, additional gait and balance outcomes derived from the dual task paradigm, the Timed Up-and-Go, fear of falling, habitual physical activity, and performance within a battery of neuropsychological tests focused on global cognitive function, attention, verbal fluency and memory.
In older adults, falls are costly, consequential and correlated with both physical and cognitive decline. Most falls occur when standing or walking. Many activities require people to stand or walk while performing tasks like talking or making decisions. Such "dual tasking" interferes with the control of standing and walking. This interference, or "cost," is exaggerated in older adults with previous falls and is predictive of future falls. Neuroimaging evidence indicates that standing and walking,especially when dual tasking, activate distributed brain networks including the left dorsolateral prefrontal cortex (dlPFC)-a brain region sub-serving executive function. Thus, strategies that facilitate activation of the left dlPFC and its connected neural networks hold promise to mitigate dual task costs, improve physical and cognitive function, and ultimately, reduce falls. Transcranial direct current stimulation (tDCS) provides a noninvasive means of selectively modulating cortical excitability. The investigators have shown in younger and older adults that a 20-minute session of tDCS designed to increase excitability of the left dlPFC reduces dual task costs and improves mobility when tested just after stimulation. The investigators have since completed a pilot, sham-controlled trial of a 2-week, 10-session tDCS intervention targeting the left dlPFC in 20 older adults with slow gait and mild-to-moderate executive dysfunction. The intervention was successfully double-blinded and well-attended. tDCS, compared to sham, reduced dual task costs and induced trends towards improved mobility and executive function over a 2-week follow-up. The investigators thus contend that tDCS targeting the left dlPFC holds promise to improve the control of standing and walking-and ultimately reduce falls-in older adults. Still, the size and duration of tDCS-induced benefits to older adult "fallers" have not been established. Moreover, to date, tDCS delivery has attempted to optimize current flow based on a "typical" brain and has thus not accounted for individual differences in skin, skull, cerebrospinal fluid and brain tissue in the aging brain. Such personalization is now possible with the current flow modeling the investigators propose. The Overall Aim is to compare, in older adults with previous falls, the effects of a personalized tDCS intervention designed to target the left dlPFC on the dual task costs to standing and walking, and other physical and cognitive factors that are on the causal pathway to falls and important to everyday function. The investigators will conduct a randomized, sham-controlled, double-blinded trial with assessments at baseline and post-intervention (immediate, 3-, 6-month follow-up) in 120 non-demented men and women (60 per arm) aged 60 or older who are at risk of falls and report mobility and balance problems and a fear of falling, yet have no major neural or musculoskeletal disorders that explain their falls. The tDCS intervention will comprise 20, 20-minute sessions of tDCS over a 4-week period. The investigators hypothesize that, in older adults at risk of falls and over a 6-month follow-up, a personalized tDCS intervention targeting the left dlPFC, as compared to sham, will mitigate dual task costs to the control of standing and walking and enhance other metrics of both physical and cognitive function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
118
The participant will receive 20, 20-minute sessions of personalized tDCS on Monday-Friday, at approximately the same time of day, over four consecutive weeks.
The participant will receive 20, 20-minute sessions of active-sham stimulation on Monday-Friday, at approximately the same time of day, over four consecutive weeks.
Hebrew Rehabilitation Center
Roslindale, Massachusetts, United States
Change from baseline in the dual task cost to gait speed
This metric will assess the change from baseline in the degree to which performing a secondary cognitive task diminishes gait speed.
Time frame: 3-day follow-up; 3-month follow-up; 6-month follow-up
Change from baseline in the dual task cost to standing postural sway speed
This metric will assess the change from baseline in the degree to which performing a secondary cognitive task diminishes the control of standing posture.
Time frame: 3-day follow-up; 3-month follow-up; 6-month follow-up
Change from baseline in Short Physical Performance Battery (SPPB)
This metric will assess the change from baseline in overall physical function.
Time frame: 3-day follow-up; 3-month follow-up; 6-month follow-up
Change from baseline in Montreal Cognitive Assessment (MoCA) total score
This common test will assess the change from baseline in global cognitive function
Time frame: 3-day follow-up; 3-month follow-up; 6-month follow-up
Change from baseline in the dual task cost to serial subtraction performance
This metric will assess the change from baseline in the degree to which standing or walking diminishes the ability to perform a cognitive task.
Time frame: 3-day follow-up; 3-month follow-up; 6-month follow-up
Change from baseline in the dual task cost to stride time variability
This metric will assess the change from baseline in the degree to which performing a secondary cognitive task diminishes the control of gait.
Time frame: 3-day follow-up; 3-month follow-up; 6-month follow-up
Change from baseline in dual task cost to walking double support time
This metric will assess the change from baseline in the degree to which performing a secondary cognitive task diminishes the control of gait.
Time frame: 3-day follow-up; 3-month follow-up; 6-month follow-up
Change from baseline in the dual task cost to standing postural sway elliptical area
This metric will assess the change from baseline in the degree to which performing a secondary cognitive task
Time frame: 3-day follow-up; 3-month follow-up; 6-month follow-up
Change from baseline in Trail Making Test B - A
This metric will assess the change from baseline in cognitive executive function.
Time frame: 3-day follow-up; 3-month follow-up; 6-month follow-up
Change from baseline in Timed Up-and-Go (TUG)
This metric will assess the change from baseline in mobility.
Time frame: 3-day follow-up; 3-month follow-up; 6-month follow-up
Change from baseline in Falls Efficacy Scale
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 (FOF) is defined as scores \>23 for this 16-item scale.
Time frame: 3-day follow-up; 3-month follow-up; 6-month follow-up
Change from baseline in 5-day accelerometry-based habitual physical activity
This metric will assess the change from baseline in the quantity and quality of habitual physical activity.
Time frame: 3-day follow-up; 3-month follow-up; 6-month follow-up
Change from baseline in Digit Span
This common test will assess the change from baseline in working memory.
Time frame: 3-day follow-up; 3-month follow-up; 6-month follow-up
Change from baseline in WAIS-IV Coding Test
This common test will assess the change from baseline in sustained attention and motor speed.
Time frame: 3-day follow-up; 3-month follow-up; 6-month follow-up
Change from baseline in Category and Phonemic Fluency Test
This common test will assess the change from baseline in word retrieval
Time frame: 3-day follow-up; 3-month follow-up; 6-month follow-up
Change from baseline in Hopkins Verbal Learning Test
This common test will assess the change from baseline in memory
Time frame: 3-day follow-up; 3-month follow-up; 6-month follow-up
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