tDCS in Elderly Fallers Study (NCT03814304) | Clinical Trial Compass
CompletedNot Applicable
tDCS in Elderly Fallers Study
United States99 participantsStarted 2019-07-08
Plain-language 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 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.
Who can participate
Age range
60 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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 p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study used personalized transcranial direct current stimulation — a form of mild brain stimulation — to try to reduce fall risk in older adults. Since it's now completed, has the data been published, and would my doctor think the results are relevant to my specific situation?
2The trial measured something called 'dual task cost to gait speed,' which looks at how well someone can walk while thinking at the same time — can my doctor explain whether that's a real concern for me, and whether there are any standard assessments or therapies already available that address the same thing?
3The study also tracked cognitive scores using the Montreal Cognitive Assessment — does my doctor think there's a meaningful connection between my cognitive health and my fall risk that we should be addressing together?
4Since this trial is completed and no longer enrolling, are there similar brain stimulation or balance-focused studies currently open that my doctor might recommend I look into instead?
5The Short Physical Performance Battery was one of the key measures in this study — has my doctor ever assessed me using that tool, and what would my results suggest about my fall risk and next steps?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in the Dual Task Cost to Gait Speed