60 Participants Needed

Exercise + tDCS for Alzheimer's Disease

(EXACT Trial)

CL
DV
MS
ES
Overseen ByElla Song
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sunnybrook Health Sciences Centre
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do 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.

What 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.12345

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.678910

Is 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.1451112

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.

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

Mild severity of impairment (standardized Mini-Mental State Examination (MMSE) score ≥19)
I have been diagnosed with Alzheimer's or a mix of Alzheimer's and vascular cognitive impairment.
I am 50 years old or older.
See 1 more

Exclusion Criteria

I haven't changed my dementia medication in the last 3 months.
I am currently taking benzodiazepines.
I haven't changed my seizure or mood medications in the last month.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combined exercise and tDCS intervention or control interventions over a 2-week period

2 weeks
Multiple visits (in-person)

Follow-up

Participants are monitored for changes in cognitive function and neuropsychiatric symptoms

2 weeks

Treatment Details

Interventions

  • Exercise
  • tDCS
Trial Overview 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.
Participant Groups
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

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials
693
Recruited
1,569,000+

Findings from Research

This study will investigate the combined effects of aerobic exercise and transcranial direct current stimulation (tDCS) on cognitive improvement in patients with Mild Cognitive Impairment (MCI) and Alzheimer's disease (AD), using a randomized trial design with 10 sessions over 2 weeks.
The primary goal is to assess the efficacy of exercise-primed tDCS on global cognition, while also exploring its impact on specific cognitive domains and neuropsychiatric symptoms, potentially revealing new mechanisms of action for tDCS in enhancing brain function.
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.Liu, CS., Herrmann, N., Song, BX., et al.[2022]
Transcranial direct current stimulation (tDCS) significantly improved cognitive function in patients with mild to moderate Alzheimer's disease, based on a meta-analysis of seven studies involving 146 patients, with a standardized mean difference of 0.37.
Single sessions of tDCS were effective, particularly when stimulating the temporal cortex, while repeated sessions and lower current densities did not show significant benefits, highlighting the need for careful consideration of treatment parameters.
Transcranial Direct Current Stimulation Improves Cognitive Function in Mild to Moderate Alzheimer Disease: A Meta-Analysis.Cai, M., Guo, Z., Xing, G., et al.[2020]
In a study involving 34 Alzheimer's disease patients, both anodal and cathodal transcranial direct current stimulation (tDCS) significantly improved cognitive function as measured by the mini-mental state examination (MMSE) compared to sham stimulation.
tDCS also reduced the P300 latency, a measure associated with cognitive processing, indicating potential benefits in neurorehabilitation for Alzheimer's patients, although it did not affect motor cortex excitability.
A double-blind randomized clinical trial on the efficacy of cortical direct current stimulation for the treatment of Alzheimer's disease.Khedr, EM., Gamal, NF., El-Fetoh, NA., et al.[2022]

References

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 Improves Cognitive Function in Mild to Moderate Alzheimer Disease: A Meta-Analysis. [2020]
A double-blind randomized clinical trial on the efficacy of cortical direct current stimulation for the treatment of Alzheimer's disease. [2022]
Potential of Transcranial Direct Current Stimulation in Alzheimer's Disease: Optimizing Trials Toward Clinical Use. [2022]
Transcranial direct current stimulation improves recognition memory in Alzheimer disease. [2022]
Moderate-to-High Intensity Physical Exercise in Patients with Alzheimer's Disease: A Randomized Controlled Trial. [2022]
The effects of physical exercise on executive function in community-dwelling older adults living with Alzheimer's-type dementia: A systematic review. [2022]
Alzheimer's Disease and Exercise: A Literature Review. [2017]
Vigorous, regular physical exercise may slow disease progression in Alzheimer's disease. [2023]
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]
11.United Statespubmed.ncbi.nlm.nih.gov
Effect of transcranial direct current stimulation on exercise performance: A systematic review and meta-analysis. [2019]
Acute effect of high-definition and conventional tDCS on exercise performance and psychophysiological responses in endurance athletes: a randomized controlled trial. [2023]
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