tDCS for Preventing Falls in Elderly

Overseen By Lewis Lipsitz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hebrew SeniorLife

Must not be taking: Sedatives, Antipsychotics, Hypnotics, Antidepressants

Disqualifiers: Gait disorder, Parkinson's, Alzheimer's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 23

Duration: 4 weeks

118 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are using sedating medications or have changed medications in the past month. Also, you cannot use neuro-active drugs.

Will I have to stop taking my current medications?

The trial excludes participants who have changed their medication within the previous month or who use sedating medications regularly. If you are on such medications, you may need to stop or adjust them to participate.

What safety data exists for tDCS in preventing falls in the elderly?

The safety of transcranial direct current stimulation (tDCS) has been extensively reviewed. A 2016 evidence-based update on tDCS safety found no reports of serious adverse effects or irreversible injury across over 33,200 sessions and 1,000 subjects, including potentially vulnerable populations like the elderly. Conventional tDCS protocols used in human trials (up to 40 minutes, 4 milliamperes, and 7.2 Coulombs) are considered safe. This suggests that tDCS is a well-tolerated and safe technique for use in older adults. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for use in humans, including older adults?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, including older adults, with no reports of serious adverse effects or irreversible injury in over 33,200 sessions across various studies. It is a non-invasive and well-tolerated technique, even in potentially vulnerable populations like the elderly. ^{1 2 3 4 5}

Is the treatment tDCS promising for preventing falls in elderly people?

Yes, tDCS is promising for preventing falls in elderly people. It can improve balance, posture, and walking ability, which are important for reducing fall risk. ^{1 2 3 4 6}

How does the treatment tDCS for preventing falls in elderly differ from other treatments?

tDCS (Transcranial Direct Current Stimulation) is unique because it is a non-invasive brain stimulation technique that can improve balance and cognitive-motor function in older adults, potentially reducing fall risk. Unlike other treatments, it involves applying a mild electrical current to specific brain areas to enhance brain activity, which may improve dual-task performance and postural control. ^{1 2 3 4 6}

What data supports the idea that tDCS for Preventing Falls in Elderly is an effective treatment?

The available research shows that tDCS can help improve balance and reduce the risk of falls in older adults. One study found that tDCS improved balance control, as seen in better performance on balance tests and reduced postural sway. Another study showed that tDCS helped improve postural stability, which is important for preventing falls. Additionally, a review of multiple studies confirmed that tDCS significantly improved balance in older adults compared to a control group. These findings suggest that tDCS is a promising treatment for reducing fall risk in the elderly. ^{1 3 4 6 7}

What data supports the effectiveness of the treatment Personalized tDCS for preventing falls in elderly?

Research shows that transcranial direct current stimulation (tDCS) can improve balance and postural control in older adults, which are important for preventing falls. Studies found that tDCS can enhance balance control, reduce postural sway, and improve dual-task walking, suggesting it may help reduce fall risk in the elderly. ^{1 3 4 6 7}

Who Is on the Research Team?

Brad Manor, PhD

Principal Investigator

Hebrew SeniorLife

Are You a Good Fit for This Trial?

This trial is for adults aged 60 or older who have fallen twice in the past year, are worried about falling again, and have mobility and balance issues. They must score below a certain level on physical performance tests but can't join if they've had recent heart attacks, active cancer treatments, severe mental health conditions, blindness, contraindications to MRI or tDCS like seizures or metal implants, dementia, sedative use changes recently, inability to stand/walk unassisted for a minute.

Inclusion Criteria

I have issues with moving around and keeping my balance.

My Trail Making Test result is within the normal range for my age and education.

I am 60 years old or older.

Exclusion Criteria

A score below 22 on the Telephone Interview of Cognitive Status (TICS)

I have been diagnosed with a major psychiatric condition like depression, schizophrenia, or psychosis.

I cannot stand or walk by myself for a minute.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive personalized tDCS intervention targeting the left dlPFC over a 4-week period

4 weeks

20 sessions (in-person)

Follow-up

Participants are monitored for changes in cognitive and physical function post-intervention

6 months

Assessments at 3-day, 3-month, and 6-month intervals

What Are the Treatments Tested in This Trial?

Interventions

• Personalized tDCS

Trial Overview The study tests whether personalized transcranial direct current stimulation (tDCS) over four weeks improves standing/walking tasks while doing another task (like counting backwards), physical abilities and cognitive functions related to fall risk in elderly with fear of falling. It compares this method against a sham intervention using various performance measures.

How Is the Trial Designed?

Group I: Personalized tDCS Experimental Treatment 1 Intervention

Personalized tDCS: 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.

Group II: Active-Sham Placebo Group 1 Intervention

The 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.

Personalized tDCS is already approved in United States, European Union for the following indications:

Approved in United States as Transcranial Direct Current Stimulation for:

• Depression
• Cognitive Impairment
• Auditory Hallucinations
• Rehabilitation for Stroke and Neurological Disorders

Approved in European Union as Transcranial Direct Current Stimulation for:

• Depression
• Cognitive Impairment
• Rehabilitation for Stroke and Neurological Disorders

Who Is Running the Clinical Trial?

Hebrew SeniorLife

Lead Sponsor

Trials

52

Recruited

273,000+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) applied during walking significantly reduced the dual-task cost to gait speed in older adults, indicating improved performance when multitasking, as shown in a study with 25 participants aged around 74 years.

In contrast, tDCS applied while seated or sham stimulation during walking did not produce any significant effects on gait speed or cognitive performance, highlighting the importance of timing and context in neuro-modulation for enhancing dual-task performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining transcranial direct current stimulation with a motor-cognitive task: the impact on dual-task walking costs in older adults. Schneider, N., Dagan, M., Katz, R., et al.[2021]

Cerebellar anodal transcranial direct current stimulation (a-tDCS) significantly improved postural stability and balance in older adults, as evidenced by decreased postural sway and increased Berg Balance Scores after a 20-minute session.

In a study involving 29 older adults, those receiving active a-tDCS showed significant improvements compared to a sham group, highlighting the potential of a-tDCS as an effective intervention for enhancing balance in the aging population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of cerebellar transcranial direct current stimulation on static and dynamic postural stability in older individuals: a randomized double-blind sham-controlled study. Ehsani, F., Samaei, A., Zoghi, M., et al.[2018]

Transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex improved cognitive function, particularly executive function, in older adults with mild-to-moderate impairments, as evidenced by significant changes in the Montreal Cognitive Assessment scores after ten sessions.

The tDCS intervention also enhanced dual-task standing and walking abilities, with these improvements lasting for at least two weeks, indicating its potential as a safe and effective cognitive-motor intervention for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation May Improve Cognitive-Motor Function in Functionally Limited Older Adults. Manor, B., Zhou, J., Harrison, R., et al.[2019]

Transcranial direct current stimulation (tDCS) significantly improves balance control in older adults, as shown by a meta-analysis of 10 studies involving 280 participants, with large effects on various balance tests.

The results indicate that tDCS can enhance performance in tasks like the timed-up-and-go test and the Berg balance scale, suggesting it could be a beneficial intervention for improving balance in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Transcranial Direct Current Stimulation (tDCS) on Balance Control in Older Adults: A Systematic Review and Meta-Analysis. Guo, Z., Bao, D., Manor, B., et al.[2022]

Anodal transcranial direct current stimulation (tDCS) applied to the supplementary motor area (SMA) significantly improved anticipatory postural adjustments (APAs) in 12 healthy older adults, indicating enhanced motor control.

The stimulation also reduced center of pressure (COP) sway path length immediately and 15 minutes after treatment, suggesting that tDCS can improve postural stability during rapid movements in older individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anodal Transcranial Direct Current Stimulation Over the Supplementary Motor Area Improves Anticipatory Postural Adjustments in Older Adults. Nomura, T., Kirimoto, H.[2020]

Transcranial direct current stimulation (tDCS) is a safe and non-invasive technique that has shown potential in improving functionality in older adults, with 7 out of 9 studies indicating better outcomes compared to sham stimulation.

Specifically, anodal tDCS applied over the motor cortex may enhance balance and posture control in healthy individuals aged 60 and above, but more high-quality trials are needed to optimize treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Transcranial Direct Current Stimulation Enhance Functionality in Older Adults? A Systematic Review. Pino-Esteban, A., Megía-García, Á., Martín-Caro Álvarez, D., et al.[2021]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Combining transcranial direct current stimulation with a motor-cognitive task: the impact on dual-task walking costs in older adults. [2021]

2. France pubmed.ncbi.nlm.nih.gov

The effects of cerebellar transcranial direct current stimulation on static and dynamic postural stability in older individuals: a randomized double-blind sham-controlled study. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation May Improve Cognitive-Motor Function in Functionally Limited Older Adults. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of Transcranial Direct Current Stimulation (tDCS) on Balance Control in Older Adults: A Systematic Review and Meta-Analysis. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Anodal Transcranial Direct Current Stimulation Over the Supplementary Motor Area Improves Anticipatory Postural Adjustments in Older Adults. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Can Transcranial Direct Current Stimulation Enhance Functionality in Older Adults? A Systematic Review. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]