Cognitive Walking + Brain Stimulation for Older Adults

Recruiting at 1 trial location

Overseen By David J Clark, ScD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Neuroplasticity-influencing drugs

Disqualifiers: Major cognitive disorder, others

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

Compensation: Varies

Number of Visits: 20

Duration: 6 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether a combination of walking exercises and brain stimulation can enhance thinking and walking abilities in older adults. Participants will receive either real electrical brain stimulation (Prefrontal Active tDCS, a type of transcranial direct current stimulation) or a sham (inactive) version, both paired with specific walking tasks. The trial aims to determine if real stimulation proves more effective than the sham treatment. Ideal candidates are those over 65 who have noticed a decline in memory or thinking skills and can walk independently for six minutes, even with a cane. As an unphased trial, this study provides a unique opportunity to contribute to innovative research focused on improving cognitive and physical health in older adults.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that are thought to influence tDCS (a type of brain stimulation) neuroplasticity (the brain's ability to change).

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that using active tDCS (a type of brain stimulation) on the front part of the brain is quite safe. Research involving 292 older adults over 3,046 sessions found no unexpected or serious side effects, indicating that active tDCS is generally well-tolerated.

Walking offers many benefits for older adults. Research shows that brisk walking for 30 minutes a day can lower the risk of age-related diseases. Aerobic activity like walking also enhances brain function and mental health in older adults.

These findings together support the safety of both active tDCS and walking exercises. Participants in the trial can feel reassured about the treatment's safety based on existing evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard approaches for cognitive decline in older adults, which often rely on medication or traditional physical therapy, cognitive walking combined with brain stimulation offers a novel way to enhance brain function. Researchers are excited about this technique because it combines complex walking exercises with transcranial direct current stimulation (tDCS) over the prefrontal cortex. This unique combination aims to improve cognitive function by engaging both physical and mental faculties simultaneously, potentially offering benefits beyond what either method could achieve alone. The active tDCS component, specifically, targets brain activity to boost cognitive processes, which is a fresh approach compared to existing treatments.

What evidence suggests that this trial's treatments could be effective for cognitive and walking function in older adults?

Research shows that using a technique called active transcranial direct current stimulation (tDCS) on the front part of the brain can help older adults improve their thinking skills. In this trial, some participants will receive active tDCS combined with walking exercises. Studies have found that combining tDCS with brain exercises can enhance memory and overall mental performance. For physical activity, research consistently shows that exercise improves thinking abilities in older adults, regardless of their current mental state. Engaging in challenging walking activities, like stepping over obstacles, can also boost brain health. Other participants in this trial will receive sham tDCS combined with walking exercises. This combination of brain stimulation and walking exercise offers hope for improving both thinking and movement in older adults. ^{6 7 8 9 10}

Who Is on the Research Team?

David J Clark, ScD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for older adults, aged 65 and above, who have noticed a decline in their memory or cognitive abilities over the past year. Participants should be able to walk on their own for six minutes, even if they need to use a cane.

Inclusion Criteria

I can walk by myself for 6 minutes, even with a cane.

I am 65 years old or older.

Objective executive function decline, based on standardized cognitive assessments

Exclusion Criteria

I do not have a cognitive disorder that affects my independence.

Percentile score less than 10th percentile on standardized cognitive assessments

Contraindications to tDCS or MRI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive complex walking exercise combined with either active or sham tDCS for 18 sessions over a 6-week period

6 weeks

18 sessions (in-person)

Follow-up

Participants are monitored for changes in executive function and walking speed post-intervention

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Prefrontal Active tDCS
• Prefrontal Sham tDCS
• Walking Exercise

Trial Overview The study is looking at whether walking exercises that make you think combined with electrical brain stimulation can help improve brain function in older adults. It compares real electrical stimulation of the brain's prefrontal area with fake (sham) stimulation.

How Is the Trial Designed?

Group I: Walking Exercise plus active tDCS Active Control 2 Interventions

The walking exercise will focus on use of complex walking tasks such as obstacle crossing, accurate foot placement, and walking on compliant surfaces. Each session will consist of 30 minutes of walking. Active tDCS will be delivered over prefrontal cortex.

Group II: Walking Exercise plus sham tDCS Placebo Group 2 Interventions

The walking exercise will focus on use of complex walking tasks such as obstacle crossing, accurate foot placement, and walking on compliant surfaces. Each session will consist of 30 minutes of walking. Sham tDCS will be delivered over prefrontal cortex.

Prefrontal Active tDCS is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Transcranial Direct Current Stimulation for:

• Depression
• Chronic Pain
• Stroke Rehabilitation
• Cognitive Enhancement

Approved in European Union as Transcranial Direct Current Stimulation for:

• Depression
• Chronic Pain
• Stroke Rehabilitation
• Cognitive Enhancement

Approved in Canada as Transcranial Direct Current Stimulation for:

• Depression
• Chronic Pain
• Stroke Rehabilitation
• Cognitive Enhancement

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a study involving 23 young adults and 21 older adults, the combination of anodal transcranial direct current stimulation (tDCS) and treadmill walking did not significantly improve gait parameters, but it did lead to a decrease in motor cortex activity, suggesting improved neural efficiency during dual-task walking.

Older adults showed higher cortical activity in several brain areas during walking tasks, which may indicate a compensatory mechanism for age-related gait dysfunction, highlighting the complexity of motor and cognitive processes involved in walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bi-Anodal Transcranial Direct Current Stimulation Combined With Treadmill Walking Decreases Motor Cortical Activity in Young and Older Adults. Orcioli-Silva, D., Islam, A., Baker, MR., et al.[2021]

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]

The pilot study involving older adults demonstrated that combining frontal lobe transcranial direct current stimulation (tDCS) with complex walking rehabilitation is feasible and safe, with 90% of participants completing the intervention without significant side effects.

Preliminary results indicated that the Active/Complex group experienced notable improvements in executive function, suggesting that tDCS may enhance the benefits of walking rehabilitation, warranting further investigation in larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Frontal Transcranial Direct Current Stimulation With Walking Rehabilitation to Enhance Mobility and Executive Function: A Pilot Clinical Trial. Clark, DJ., Chatterjee, SA., Skinner, JW., et al.[2022]

In a study of 50 older adults with walking difficulties, pairing active transcranial direct current stimulation (tDCS) with practice of a complex obstacle negotiation task led to significant retention of walking performance gains one week later compared to no tDCS.

However, during the practice session, the sham tDCS group showed greater immediate improvements in walking speed than both the active tDCS and no tDCS groups, indicating that active tDCS did not enhance immediate performance gains over sham stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Prefrontal Transcranial Direct Current Stimulation on Retention of Performance Gains on an Obstacle Negotiation Task in Older Adults. Chatterjee, SA., Seidler, RD., Skinner, JW., et al.[2023]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

Transcranial direct current stimulation (tDCS) significantly improved walking speed and functional strength of lower limbs in a study of 57 healthy older adults, indicating its potential as a method to enhance physical function.

The study demonstrated that tDCS is a safe and effective intervention for improving motor performance, particularly in gait and balance, although it did not show significant effects on dynamic balance for the right side.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Transcranial Direct Current Stimulation on Walking Speed, Functional Strength, and Balance in Older Adults: A Randomized, Double-Blind Controlled Trial. Yi, D., Sung, Y., Yim, J.[2022]

In a study involving 16 individuals with chronic stroke, a single session of transcranial direct current stimulation (tDCS) did not show significant improvements in walking performance compared to sham stimulation, indicating mixed effects of tDCS on gait.

However, personalized responses to tDCS suggested potential benefits in fastest comfortable gait speed and paretic step ratio, highlighting the importance of individual variability in response to different electrode montages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation Electrode Montages May Differentially Impact Variables of Walking Performance in Individuals Poststroke: A Preliminary Study. Seamon, BA., Bowden, MG., Kindred, JH., et al.[2023]

Transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex (dlPFC) significantly reduced the oxygen consumption (ΔHbO2 cost) in this brain region during dual task walking in older adults, indicating improved efficiency in brain activity related to walking tasks.

The study involved a small subset of seven participants per group, and the results showed that tDCS specifically affected the left prefrontal cortex during dual task conditions, while sham stimulation had no effect, suggesting that tDCS may enhance cognitive and motor function in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation May Reduce Prefrontal Recruitment During Dual Task Walking in Functionally Limited Older Adults - A Pilot Study. Jor'dan, AJ., Bernad-Elazari, H., Mirelman, A., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11456488/

A meta-analysis of the effects of transcranial direct current ... The results show that active tDCS combined with CT statistically effectively improved WM in healthy older adults compared to the control ...

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

Effects of transcranial direct current stimulation on dual- ... Modulation of prefrontal activity using tDCS can effectively decrease the cost of performing cognitive tasks during walking or standing in older adults.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9836784/

Effects of Multi-Session Prefrontal Transcranial Direct ... The present study reports results from a multi-session intervention in older adults comparing active and sham tDCS over the left dorsolateral prefrontal cortex ...

4. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2022.843122/full

Transcranial Direct Current Stimulation May Reduce ... A recent meta-analysis of published evidence concluded that tDCS appears to be a promising tool to counteract age- and disease-related declines ...

5. nature.com nature.com/articles/s41598-025-08322-6

Enhanced cognitive performance in older adults through ... These findings suggest that combining CT with active tDCS is more effective in enhancing and sustaining cognitive performance in older adults compared to CT ...

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35410769/

Effects of Prefrontal Transcranial Direct Current Stimulation on ... Pairing prefrontal active tDCS with a single session of obstacle negotiation practice may enhance one-week retention of gains in walking performance compared ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X23019010

Tolerability and blinding of high-definition transcranial ... Safety: Across the 292 older adults and 3046 sessions, there were no unexpected or severe adverse events related to HD-tDCS. Thus, there were no safety concerns ...

9. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2022.814204/full

Anodal Transcranial Direct Current Stimulation Over ... Transcranial direct current stimulation (tDCS) has emerged to be especially promising because of its low cost, safety, portability, and its ability to be ...

10. tandfonline.com tandfonline.com/doi/full/10.1080/0361073X.2025.2468103?af=R

Full article: Comparison of the Effect of Active Video Games ... The results of the study demonstrated that AVG and tDCS significantly improved working memory and cognitive flexibility in the elderly.