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Neuromodulation
Cognitive Walking + Brain Stimulation for Older Adults
N/A
Recruiting
Led By David J Clark, ScD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-intervention (an average of 6 weeks after baseline), follow-up (an average of 12 weeks after post-intervention)
Summary
This trial aims to test if using a combination of cognitive walking exercises and electrical brain stimulation can help older adults improve their cognitive and walking functions. The study will compare the effects of real brain stimulation with fake
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects from the non-invasive electrical brain stimulation may include mild itching, tingling on the scalp, brief discomfort or fatigue. Walking exercise is generally safe but could potentially cause muscle soreness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post-intervention (an average of 6 weeks after baseline), follow-up (an average of 12 weeks after post-intervention)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-intervention (an average of 6 weeks after baseline), follow-up (an average of 12 weeks after post-intervention)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
score on test of executive function
walking speed for obstacle task negotiation task
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Walking Exercise plus active tDCSActive Control2 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 tDCSPlacebo Group2 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.
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,409 Previous Clinical Trials
767,339 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,803 Previous Clinical Trials
28,193,891 Total Patients Enrolled
David J Clark, ScDPrincipal InvestigatorUniversity of Florida