Home-based tDCS for Older Adults at Risk of Falling

Overseen By Nicole LaGanke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hebrew SeniorLife

Must not be taking: Neuro-active drugs

Disqualifiers: Cognitive impairment, Seizures, Implanted devices, others

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

Compensation: Varies

Number of Visits: Unknown

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores an at-home treatment called transcranial direct current stimulation (tDCS) to help older adults improve balance and mobility, particularly those who have recently experienced falls. The trial will determine if this treatment, which uses mild electrical currents to the brain, can be safely and effectively administered at home with the assistance of a caregiver or partner. Adults who have fallen in the past year or are concerned about falling again, and can walk unassisted for short distances, may be suitable candidates. The goal is to assess whether caregivers can safely administer this treatment and if it helps reduce falls over time. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance at-home care for fall prevention.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes participants using neuro-active drugs. If you are on such medications, you may not be eligible to participate.

What prior data suggests that this home-based tES intervention is safe for older adults at risk of falling?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for older adults. Most people feel little to no sensation during the procedure. One study found no safety issues during high-definition tDCS sessions.

Previous studies indicate that using tDCS for up to 20 days is safe and can significantly improve thinking skills. This suggests it might help with conditions like depression in older adults.

When combined with transcranial alternating current stimulation (tACS) at 40 Hz, studies suggest tDCS is safe and may benefit cognitive issues in older adults. Trials using these methods reported no major side effects.

Overall, both tDCS and the combination of tDCS and tACS are well-tolerated, with few side effects reported in studies. These methods show promise for safely helping older adults who are at risk of falling. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using transcranial electrical stimulation (tES) for older adults at risk of falling because it offers a non-invasive, home-based approach to enhancing brain function. Unlike traditional balance training or physical therapy methods, tES directly targets the brain's dorsolateral prefrontal cortex (dlPFC) to improve cognitive and motor control, potentially reducing fall risk. Additionally, the combination of tDCS and tACS provides a dual action by stimulating different brain areas, which could lead to more comprehensive improvements in balance and coordination. This innovative approach allows participants to receive treatment in the comfort of their own homes, making it more accessible and convenient compared to other options.

What evidence suggests that this tES intervention is effective for improving mobility in older adults at risk of falling?

Research has shown that transcranial direct current stimulation (tDCS) can help older adults improve balance and reduce the risk of falling. One study found that tDCS significantly enhanced both static and dynamic balance, crucial for fall prevention. Another study suggested that tDCS could aid in treating falls and frailty in older adults. Participants in a study attended 82.3% of the possible sessions and found the treatment practical and safe. In this trial, participants may receive either tDCS alone or a combination of tDCS and transcranial alternating current stimulation (tACS). These findings suggest that tDCS could effectively assist older adults at risk of falling. ^{6 7 8 9 10}

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 pairs of older adults (60+) at risk of falling and their caregivers who are available weekdays. Participants must have had a fall in the past year or fear future falls, with no severe mobility issues, seizures, certain medical devices, or skin conditions on the scalp.

Inclusion Criteria

PF group:

Self-reported computer proficiency and willingness to learn how to use tDCS

I have fallen in the past year, am worried about falling, or have Parkinson's disease.

Exclusion Criteria

I don't have seizures, use neuro-active drugs, have metal in my head, specific implants, or untreated skin conditions on my scalp.

I cannot walk by myself for at least 25 feet.

Evidence of cognitive impairment that would likely interfere with one's ability to understand the study protocol, risks/benefits, and testing procedures. This will be defined as self-reported diagnosis of Alzheimer's disease or dementia, a score of ≤19 on the Telephone Interview for Cognitive Status (TICS) at the time of telephone screening, a score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person screen, or an inability to understand study procedures following review of the Informed Consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Training Development

Development and refinement of training materials for home-based tDCS for PF/PA pairs

4-6 weeks

Phase 2: Pilot Trial

Pilot trial in 12 PF/PA pairs to assess feasibility of home-based tES

6 weeks

Multiple visits for in-person training

Phase 3: Extended Pilot Trial

Extended pilot trial in up to 18 PF/PA pairs to explore compliance and safety over a longer period

52 weeks

Phase 4: Long-term Pilot Trial

Long-term pilot trial in up to 18 PF/PA teams to assess safety, effectiveness, and adherence over an extended period

156 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview The study tests if caregivers can safely administer tDCS at home to improve mobility in older adults prone to falling. It's divided into three phases: developing training materials, piloting the intervention with 12 pairs, and expanding to up to 18 pairs over a longer period.

How Is the Trial Designed?

Group I: tES (transcranial electrical stimulation) Experimental Treatment 1 Intervention

All participants in phase 1 received the tDCS (transcranial direct current stimulation) intervention. For each new potential participant recruited into Phase 2, 3 or 4, the type of tES intervention, either tDCS or a combination of tDCS and tACS (transcranial alternating current stimulation) will be determined at the discretion of the study PI in consultation with the participant. The tDCS intervention will be administered with the goal of facilitating the excitability of the left dlPFC (dorsolateral prefrontal cortex). The combination of tDCS and tACS intervention will be administered with the goals of 1) using tDCS to facilitate the excitability of the left dlPFC using the parameters outlined in the preceding paragraph, and at the same time, 2) using tACS targeting the left angular gyrus at gamma frequency 40 Hz.

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) 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]

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) 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]

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) 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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10757166/

Feasibility and Safety of Sequential Transcranial Direct ... Six fallers (88.8±5.0 y/o, 5F) completed the study and received 82.3% of the possible stimulation sessions, suggesting adding a 20-minute session of stimulation ...

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

Non-invasive neuromodulation in reducing the risk of falls and ... Transcranial direct current stimulation (tDCS) has shown promise in treating falls and frailty syndrome in the older adults. tDCS is being ...

3. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2025.1645962/full

The effect of transcranial direct current stimulation on static ... This systematic review and meta-analysis demonstrated that tDCS significantly improved both static and dynamic postural control in healthy older adults. ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2950307824000444

Effects of transcranial direct current stimulation on dual- ... Feasibility and safety of sequential transcranial direct current stimulation and physical therapy in older adults at risk of falling: A randomized pilot study.

5. 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 ...

6. 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.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5007190/

Safety of transcranial Direct Current Stimulation: Evidence ... This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11218548/

Tolerability and blinding of high-definition transcranial ... There were no safety-related adverse events. HD-tDCS was well tolerated with mostly no (“none”) or “mild” sensations reported across sessions, ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1064748125003781

Efficacy and Safety of Transcranial Direct Current ... These findings suggest that tDCS may be a promising nonpharmacological treatment option for depression in older adults, particularly in the context of comorbid ...

10. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1356073/full

Safety and feasibility of optimized transcranial direct ... Previous research has shown that tDCS can be safely used for 20 days and has significant effects on cognitive function (11, 12). Although there ...