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Accidental FallsNCT03814304

tDCS in Elderly Fallers Study

A study testing tDCS in people with Accidental Falls and Aging, run by Hebrew SeniorLife at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to determine if a four-week, 20-session intervention of 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… Read more about this study

Who is it for?
Ages 60 to 100 years
Conditions the study is for
Accidental Falls, Aging
What is being tested?
tDCS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
1 siteUnited States
Study dates
8 Jul 2019to 31 Jul 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women aged 60 or older
  • Self-report of mobility and balance problems
  • Self-report of fear of falling defined by a "yes" answer to the yes-or-no question "Is the participant worried about falling in the future?"
  • Trail Making Test (TMT) Part B time below 75th percentile of age-and education-based norms
  • A score of 10 or below on the Short Physical Performance Battery

Who cannot join

  • Inability to stand or walk unassisted for 60 seconds
  • Hospitalization within the past three months due to acute illness, or as the result of a musculoskeletal injury significantly affecting gait or balance
  • Any unstable medical condition
  • a diagnosis of a gait disorder, Parkinson's disease, Alzheimer's disease or dementia, multiple sclerosis, previous stroke or other neurodegenerative disorder
  • Chronic vertigo
  • Myocardial infarction within the past 6 months
Show all 13Show fewer
  • Active cancer for which chemo-/radiation therapy is being received
  • Psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
  • Chronic use of any sedating medications (sedatives, anti-psychotics, hypnotics, anti-depressants) or change in medication within the previous month
  • Legal blindness
  • Contraindications to MRI or tDCS, including reported seizure within the past two years, use of neuro-active drugs, the risk of metal objects anywhere in the body, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp
  • A score below 22 on the Telephone Interview of Cognitive Status (TICS)
  • Mild or severe dementia defined by a Clinical Dementia Rating (CDR) score of one or greater

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Hebrew Rehabilitation Center

    Roslindale, Massachusetts, 02131

Other trials in United States

About this study

Official title: Personalized Brain Activity Modulation to Improve Balance and Cognition in Elderly Fallers

The objective of this study is to determine if a four-week, 20-session intervention of 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.

Read the detailed description

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 modeling 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 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 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.

Being tested
tDCS, Active-Sham

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tDCSOther

    The participant will receive 20, 20-minute sessions of tDCS on Monday-Friday, at approximately the same time of day, over four consecutive weeks.

  • Active-ShamOther

    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.

Study groups in NCT03814304
Study groupRoleWhat they receive
tDCSExperimentaltDCS: 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.
Receives: Other: tDCS
Active-ShamSham comparatorThe 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.
Receives: Other: Active-Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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. 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.

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

Secondary outcomes (16)
  1. 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 is defined as scores >23 for this 16-item scale. The decrease of this scale indicates lower fear of falling.

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

  2. Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score

    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.

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

  3. Change From Baseline in Short Physical Performance Battery (SPPB)

    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.

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

  4. 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. 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.

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

  5. Change From Baseline in the Dual Task Cost to the Correct Rate of Serial Subtraction

    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.

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

  6. Change From Baseline in Trail Making Test B - A

    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.

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

  7. Change From Baseline in Timed-Up-and-Go (TUG) Time

    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.

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

  8. Change From Baseline in Digit Span

    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.

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

  9. Change From Baseline in Category and Phonemic Fluency Test

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

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

  10. Change From Baseline in Retention Rate in Hopkins Verbal Learning Test

    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.

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

  11. Change From Baseline in Short Form (SF) - 12-physical

    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.

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

  12. Change From Baseline in Short Form (SF)-12-mental

    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.

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

  13. Change From Baseline in Dual Task Gait Speed

    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.

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

  14. Change From Baseline in Dual Task Gait Stride Time Variability

    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.

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

  15. Changes From Baseline in Gait Speed in Single Task Condition

    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.

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

  16. Changes From Baseline in Gait Stride Time Variability in Single Task Condition

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2019
  2. Study start8 Jul 2019
  3. Primary completion24 Jan 2025
  4. Study completion31 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The investigators will conduct a single site, sham-controlled, double-blinded, randomized trial of tDCS. Participants will perform baseline functional assessments, as well as a structural MRI of the brain. They will then be assigned to a four-week, 20-session intervention of either tDCS or sham (i.e., control) stimulation, via permuted block randomization stratified by sex to ensure that equal numbers of women, and equal numbers of men, are randomized to each arm.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03814304
Sponsor's protocol ID
AG059089-01
Other IDs
R01AG059089
Status last verified
Jul 2026
First submitted
9 Jan 2019
Last updated
28 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The HSL Institute for Aging Research will promote the development of new research and new investigators by making the data available to outside investigators. The database will include longitudinal demographic, clinical, functional, physiologic, and brain imaging data, from all participants. All data will be stripped of primary identifiers and entered into a master database. All data collection procedures, variable definitions and codes, field locations, and frequencies will be documented in a separate file.

Questions about this trial

What is this clinical trial studying?

A study testing tDCS in people with Accidental Falls and Aging, run by Hebrew SeniorLife at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Dual Task Cost to Gait Speed (time frame: 3-day follow-up; 3-month follow-up; 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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