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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transcranial direct current stimulation (tDCS) can aid older adults with balance and walking, aiming to prevent falls. The study compares this brain-stimulation treatment to a placebo to determine its effectiveness. It seeks participants aged 60 or older who have experienced two or more falls in the past year and are concerned about falling again. Those with mobility and balance issues, but without serious neurological or musculoskeletal conditions, may be suitable candidates. As an unphased trial, this study offers an opportunity to contribute to important research that could enhance fall prevention strategies for older adults.

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 prior data suggests that this tDCS intervention is safe for preventing falls in the elderly?

Research shows that transcranial direct current stimulation (tDCS) is generally safe for people, including older adults. Studies have not reported any serious side effects. The procedure is non-invasive, meaning it doesn't involve surgery or entering the body.

In one study with very frail older adults, tDCS proved both practical and safe, causing no major health problems and suggesting it is well-tolerated. Another study found that tDCS can improve balance and brain functions in older adults without causing harm.

Overall, personalized tDCS has shown safety for older adults, with only minor side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about personalized transcranial direct current stimulation (tDCS) for preventing falls in the elderly because it offers a non-invasive approach to enhance brain activity, specifically targeting the left dorsolateral prefrontal cortex (dlPFC). Unlike traditional treatments like physical therapy or medication, which focus on improving muscle strength or balance, tDCS aims to directly influence brain function to enhance cognitive processes that can help prevent falls. This approach uses a gentle electrical current to stimulate the brain, potentially offering a novel way to reduce fall risk without the side effects associated with medications. The personalized nature of this tDCS treatment means it can be tailored to each individual's needs, maximizing its effectiveness and comfort.

What evidence suggests that personalized tDCS is effective for preventing falls in the elderly?

Research has shown that personalized transcranial direct current stimulation (tDCS), which participants in this trial may receive, can help older adults improve balance and mobility. Studies have found that tDCS makes standing still without wobbling easier, which is crucial for preventing falls, especially in older individuals. The treatment is safe and suitable even for very frail older adults. These findings suggest that personalized tDCS might reduce fall risk by enhancing both physical and mental abilities related to balance and walking. Another group in this trial will receive an active-sham treatment, designed to mimic the sensations of tDCS without significantly affecting cortical tissue. ^{1 2 3 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) 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]

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) 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) 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]

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) 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. clinicaltrials.gov clinicaltrials.gov/study/NCT03814304

NCT03814304 | Personalized tDCS in Elderly Fallers Study The objective of this study is to determine if a four-week, 20-session intervention of personalized transcranial direct current stimulation (tDCS), as compared ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2837962

Personalized Transcranial Direct Current Stimulation for ... This comparative effectiveness study compares the behavioral and neurophysiologic outcomes associated with fixed-dose vs individualized-dose ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12380813/

The effect of transcranial direct current stimulation on static ... Compared to control conditions, tDCS significantly improved following outcomes in older adults, static postural stability index (APSIstatic: p < ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2590109523000447

Feasibility and Safety of Sequential Transcranial ... This study provides preliminary evidence about the feasibility, safety, and challenges to combine PT and tDCS in very frail older adults.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03814304/personalized-tdcs-in-elderly-fallers-study

Personalized tDCS in Elderly Fallers Study The objective of this study is to determine if a four-week, 20-session intervention of personalized transcranial direct current stimulation ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10956576/

Non-invasive neuromodulation in reducing the risk of falls and ... These findings indicate that tDCS can be used as a non-invasive and safe method to enhance cognitive processes in the older adults, potentially ...

7. withpower.com withpower.com/trial/phase-6-2019-08f59

tDCS for Preventing Falls in Elderly · Info for Participants Transcranial direct current stimulation (tDCS) is generally considered safe for humans, including older adults, with no reports of serious adverse effects or ...