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

Trial Summary

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).

What data supports the effectiveness of the treatment Cognitive Walking + Brain Stimulation for Older Adults?

Research suggests that transcranial direct current stimulation (tDCS) targeting the prefrontal cortex can improve walking performance in older adults, especially when combined with walking exercises. Studies have shown that tDCS may enhance neural efficiency and improve complex walking tasks, indicating potential benefits for mobility and cognitive function. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for older adults?

Transcranial direct current stimulation (tDCS) is generally reported as safe, but there are warnings that it could potentially cause harmful effects in healthy individuals. It's important for participants to be aware of these risks and discuss them with the research team. ^{1 2 6 7 8}

How is the Cognitive Walking + Brain Stimulation treatment different from other treatments for older adults?

This treatment is unique because it combines transcranial direct current stimulation (tDCS) with walking exercises to improve both cognitive and motor functions in older adults. Unlike other treatments that may focus solely on physical or cognitive aspects, this approach targets the brain's prefrontal cortex to enhance dual-task walking, which involves walking while performing a cognitive task, potentially improving overall neural efficiency. ^{1 2 3 6 9}

What is the purpose of this trial?

Declines in cognitive function and walking function are highly intertwined in older adults. A therapeutic approach that combines complex (cognitively engaging) aerobic walking exercise with non-invasive electrical brain stimulation may be effective at restoring lost function. This study tests whether electrical stimulation of prefrontal brain regions is more beneficial than sham stimulation.

Research Team

David J Clark, ScD

Principal Investigator

University of Florida

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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]

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) 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) 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]

References

1. Switzerland 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. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Bi-Anodal Transcranial Direct Current Stimulation Combined With Treadmill Walking Decreases Motor Cortical Activity in Young and Older Adults. [2021]

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

Transcranial Direct Current Stimulation Electrode Montages May Differentially Impact Variables of Walking Performance in Individuals Poststroke: A Preliminary Study. [2023]

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

Combining Frontal Transcranial Direct Current Stimulation With Walking Rehabilitation to Enhance Mobility and Executive Function: A Pilot Clinical Trial. [2022]

5. United States 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. [2023]

6. United States 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. [2022]

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

Safety of transcranial direct current stimulation in healthy participants. [2021]

8. 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]

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

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