Exercise + tDCS for Alzheimer's Disease (EXACT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Sunnybrook Health Sciences Centre
No Placebo Group
Trial Summary
What is the purpose of this trial?Mild cognitive impairment and Alzheimer's disease are conditions that involve memory difficulties. Transcranial direct current stimulation is a type of brain stimulation. It may help improve these memory difficulties. However, it works better on active brain areas. This study looks at if combining exercise and applying current to important parts of the brain can help improve memory in people with Mild Cognitive Impairment or Alzheimer's disease.
What safety data exists for exercise and tDCS in Alzheimer's treatment?
The provided research primarily focuses on the effects of physical exercise on Alzheimer's disease, highlighting its potential benefits such as improved cognitive function, reduced neuropsychiatric symptoms, and slower decline in daily activities. Exercise is generally considered safe with fewer side effects compared to medications. However, there is no specific mention of safety data for the combination of exercise and transcranial direct current stimulation (tDCS) in these studies. Further research would be needed to evaluate the safety of this combined treatment approach.
3451112Is Exercise and tDCS a promising treatment for Alzheimer's Disease?
Yes, combining exercise with tDCS, a type of brain stimulation, shows promise in improving brain function in Alzheimer's patients. Exercise can make the brain more active, which might help tDCS work better to boost memory and thinking skills.
168910What data supports the idea that Exercise + tDCS for Alzheimer's Disease is an effective treatment?
The available research shows that combining exercise with transcranial direct current stimulation (tDCS) could be effective for Alzheimer's Disease. Exercise is known to make the brain more active, which might help tDCS work better. Some studies have shown that tDCS can improve thinking skills in people with mild to moderate Alzheimer's Disease. While the research is still developing, there is growing evidence that this combination could help slow down memory loss and improve brain function in Alzheimer's patients.
127910Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot join if you've changed cognitive enhancing medications in the last 3 months or anticonvulsants/psychotropic medications in the last month. You also cannot be taking benzodiazepines.
Eligibility Criteria
This trial is for individuals over 50 with mild Alzheimer's or cognitive impairment who can communicate in English and have an MMSE score of at least 19. It's not suitable for those recently changing medication, using benzodiazepines, having metal implants like pacemakers, other significant neurological conditions, psychiatric disorders, substance use disorder, or medical reasons preventing exercise.Inclusion Criteria
I have been diagnosed with Alzheimer's or a mix of Alzheimer's and vascular cognitive impairment.
I am 50 years old or older.
Exclusion Criteria
I am currently taking benzodiazepines.
I have a significant neurological condition like epilepsy or Parkinson's.
Participant Groups
The study tests if brain stimulation (tDCS) combined with exercise improves memory in people with Mild Cognitive Impairment or Alzheimer's. Participants will receive either real tDCS while exercising or a sham treatment without active stimulation alongside exercise education.
3Treatment groups
Experimental Treatment
Group I: Exercise and tDCSExperimental Treatment2 Interventions
Patients randomized to this group will attend Toronto Rehabilitation Institute - University Health Network (TRI-UHN) for an individualized exercise program and active tDCS intervention.
Group II: Exercise and Sham tDCSExperimental Treatment2 Interventions
Patients randomized to this group will attend TRI-UHN for an individualized exercise program and sham tDCS intervention.
Group III: Exercise Education and tDCSExperimental Treatment2 Interventions
Patients randomized to this group will undergo treatment as usual, receiving routine advice about physical activity and active tDCS intervention.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Sunnybrook Health Sciences CentreToronto, Canada
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
References
Transcranial direct current stimulation improves recognition memory in Alzheimer disease. [2022]To evaluate the cognitive effect of transcranial direct current stimulation (tDCS) over the temporoparietal areas in patients with Alzheimer disease (AD).
A double-blind randomized clinical trial on the efficacy of cortical direct current stimulation for the treatment of Alzheimer's disease. [2022]The purpose of this study was to investigate the long-term efficacy of transcranial direct current stimulation (tDCS) in the neurorehabilitation of Alzheimer's disease (AD).
Moderate-to-High Intensity Physical Exercise in Patients with Alzheimer's Disease: A Randomized Controlled Trial. [2022]Studies of physical exercise in patients with Alzheimer's disease (AD) are few and results have been inconsistent.
Alzheimer's Disease and Exercise: A Literature Review. [2017]Alzheimer's disease (AD) is a progressive neurodegenerative disease that impairs memory and cognitive judgment. It is the leading cause of dementia in late adult life and is associated with a significant social burden and increased morbidity and mortality in the elderly. Because of mixed effectiveness of medications, exercise has been considered as a treatment for pre-clinical AD, late stage AD, and as a prevention strategy. Exercise appears to improve brain blood flow, increase hippocampal volume, and improve neurogenesis. Prospective studies indicate that physical inactivity is one of the most common preventable risk factors for developing AD and that higher physical activity levels are associated with a reduced risk of development of disease. Exercise as a treatment for AD shows improvement in cognitive function, decreased neuropsychiatric symptoms, and a slower decline in activities of daily living (ADL). Exercise has been shown to have fewer side effects and better adherence compared to medications.
The effects of physical exercise on executive function in community-dwelling older adults living with Alzheimer's-type dementia: A systematic review. [2022]Executive function deficit is an indicator of Alzheimer's-type dementia and manifests as disruptions of attentional control, memory, cognitive flexibility, planning, and reasoning, among other cognitive problems. Physical exercise is suggested to have a protective effect on global cognition with aging. However, whether it influences executive function in people living with Alzheimer's-type dementia specifically is unknown. The current systematic review examined the efficacy of physical exercise on executive function performance in community-dwelling older adults living with Alzheimer's-type dementia. An electronic search of databases retrieved randomized and non-randomized controlled trials of community-dwelling older adults diagnosed with Alzheimer's-type dementia who completed a physical exercise intervention and who were assessed using an executive function outcome measure. Methodological quality of six studies meeting the inclusion criteria published between 2009 and 2016 was scored independently by two raters using the Physiotherapy Evidence Database and a Cochrane informed domain-based assessment of risk of bias. Trends toward improvement in executive function scores were seen across all six studies, and significant improvement was seen in four of the eligible studies. Future studies should explore the benefits of the American College of Sports Medicine recommended 150 min of physical exercise per week with select measures of executive function.
Effect of transcranial direct current stimulation on exercise performance: A systematic review and meta-analysis. [2019]Transcranial direct current stimulation (tDCS) has been used to improve exercise performance, though the protocols used, and results found are mixed.
Transcranial Direct Current Stimulation Improves Cognitive Function in Mild to Moderate Alzheimer Disease: A Meta-Analysis. [2020]The purpose of this meta-analysis was to evaluate the therapeutic effect of transcranial direct current stimulation (tDCS) on mild to moderate Alzheimer disease (AD) patients.
Acute effect of high-definition and conventional tDCS on exercise performance and psychophysiological responses in endurance athletes: a randomized controlled trial. [2023]Transcranial direct current stimulation (tDCS) has been used aiming to boost exercise performance and inconsistent findings have been reported. One possible explanation is related to the limitations of the so-called "conventional" tDCS, which uses large rectangular electrodes, resulting in a diffuse electric field. A new tDCS technique called high-definition tDCS (HD-tDCS) has been recently developed. HD-tDCS uses small ring electrodes and produces improved focality and greater magnitude of its aftereffects. This study tested whether HD-tDCS would improve exercise performance to a greater extent than conventional tDCS. Twelve endurance athletes (29.4 ± 7.3 years; 60.15 ± 5.09 ml kg-1 min-1) were enrolled in this single-center, randomized, crossover, and sham-controlled trial. To test reliability, participants performed two time to exhaustion (TTE) tests (control conditions) on a cycle simulator with 80% of peak power until volitional exhaustion. Next, they randomly received HD-tDCS (2.4 mA), conventional (2.0 mA), or active sham tDCS (2.0 mA) over the motor cortex for 20-min before performing the TTE test. TTE, heart rate (HR), associative thoughts, peripheral (lower limbs), and whole-body ratings of perceived exertion (RPE) were recorded every minute. Outcome measures were reliable. There was no difference in TTE between HD-tDCS (853.1 ± 288.6 s), simulated conventional (827.8 ± 278.7 s), sham (794.3 ± 271.2 s), or control conditions (TTE1 = 751.1 ± 261.6 s or TTE2 = 770.8 ± 250.6 s) [F(1.95; 21.4) = 1.537; P = 0.24; η2p = 0.123]. There was no effect on peripheral or whole-body RPE and associative thoughts (P > 0.05). No serious adverse effect was reported. A single session of neither HD-tDCS nor conventional tDCS changed exercise performance and psychophysiological responses in athletes, suggesting that a ceiling effect may exist.
Exercise priming with transcranial direct current stimulation: a study protocol for a randomized, parallel-design, sham-controlled trial in mild cognitive impairment and Alzheimer's disease. [2022]Transcranial direct current stimulation (tDCS) is a non-invasive type of brain stimulation that uses electrical currents to modulate neuronal activity. A small number of studies have investigated the effects of tDCS on cognition in patients with Mild Cognitive Impairment (MCI) and Alzheimer's disease (AD), and have demonstrated variable effects. Emerging evidence suggests that tDCS is most effective when applied to active brain circuits. Aerobic exercise is known to increase cortical excitability and improve brain network connectivity. Exercise may therefore be an effective, yet previously unexplored primer for tDCS to improve cognition in MCI and mild AD.
Potential of Transcranial Direct Current Stimulation in Alzheimer's Disease: Optimizing Trials Toward Clinical Use. [2022]Transcranial direct current stimulation (tDCS) is a safe and well-tolerated noninvasive method for stimulating the brain that is rapidly developing into a treatment method for various neurological and psychiatric conditions. In particular, there is growing evidence of a therapeutic role for tDCS in ameliorating or delaying the cognitive decline in Alzheimer's disease (AD). We provide a brief overview of the current development and application status of tDCS as a nonpharmacological therapeutic method for AD and mild cognitive impairment (MCI), summarize the levels of evidence, and identify the improvements needed for clinical applications. We also suggest future directions for large-scale controlled clinical trials of tDCS in AD and MCI, and emphasize the necessity of identifying the mechanistic targets to facilitate clinical applications.
Vigorous, regular physical exercise may slow disease progression in Alzheimer's disease. [2023]Mild to moderate exercise may decrease Alzheimer's disease (AD) risk, but the effects of vigorous, regular physical exercise remain unclear.
Moderate and vigorous leisure time physical activity in older adults and Alzheimer's disease-related mortality in the USA: a dose-response, population-based study. [2023]Data for the dose-response associations of moderate physical activity (MPA) and vigorous physical activity (VPA) with Alzheimer's disease-related mortality are scarce. We aimed to examine the prospective associations of such activity with Alzheimer's disease-related mortality.