80 Participants Needed

Exercise + Brain Stimulation for Vascular Cognitive Impairment

(EXPRESS-V Trial)

MS
VF
Overseen ByVivian Feng
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

What is the purpose of this trial?

People with vascular conditions are at risk of having memory problems, and these memory problems increase the risk for further cognitive decline. Brain stimulation has been used to improve mood and memory. Transcranial direct current stimulation (tDCS) is believed to work best on brain cells that are active or "primed" before stimulation. The purpose of this study is to compare the effects of exercise and tDCS on memory performance in patients who have completed cardiac rehabilitation and are at risk of cognitive decline.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have changed psychotropic medications in the last 4 weeks or are currently using benzodiazepines, you may not be eligible to participate.

What data supports the effectiveness of the treatment Exercise + Brain Stimulation for Vascular Cognitive Impairment?

Research suggests that combining exercise with transcranial direct current stimulation (tDCS) may enhance brain function, as exercise increases brain activity, potentially making tDCS more effective. Studies have shown that tDCS can improve cognitive function in conditions like mild cognitive impairment and Alzheimer's disease, and enhance physical performance, indicating potential benefits for vascular cognitive impairment.12345

Is the combination of exercise and transcranial direct current stimulation (tDCS) safe for humans?

Research shows that transcranial direct current stimulation (tDCS) is generally safe for humans when used at conventional levels (up to 4 milliamperes for 40 minutes) and has not resulted in serious adverse effects across thousands of sessions. Exercise is also widely recognized as safe for most people. Combining these two methods has not shown any severe side effects, but more research is needed to fully understand their interactions.36789

How does the treatment of exercise combined with tDCS differ from other treatments for vascular cognitive impairment?

This treatment is unique because it combines physical exercise with transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique that can enhance exercise performance and potentially improve cognitive function by modulating brain activity. Unlike traditional treatments, this approach targets both physical and cognitive aspects, potentially offering a more comprehensive benefit for vascular cognitive impairment.23101112

Research Team

KL

Krista Lanctôt, PhD

Principal Investigator

Sunnybrook Research Institute

Eligibility Criteria

This trial is for English-speaking adults over 50, especially post-menopausal women, with cardiovascular risks or disease and mild memory issues. They must be able to exercise moderately but can't have had a stroke, recent psychotropic medication changes, benzodiazepine use, metal implants affecting brain stimulation safety, or significant neurological/psychiatric conditions.

Inclusion Criteria

I am over 50 and, if female, I am post-menopausal.
Must be able to exercise at a moderate intensity level
Presence of modest deficits (1 standard deviation below population norm) in one of the following domains: executive function, verbal memory, working memory, or visuospatial memory
See 3 more

Exclusion Criteria

Any medical contraindications to exercise
I am currently taking benzodiazepines.
I have had a stroke in the past.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to one of four interventions: Exercise primer with tDCS, Treatment as usual with tDCS, Exercise primer with sham tDCS, or Treatment as usual with sham tDCS. Interventions include exercise and/or tDCS.

2 weeks

Follow-up

Participants are monitored for cognitive and behavioral changes after treatment

4 weeks

Treatment Details

Interventions

  • Exercise
  • Sham stimulation
  • tDCS
  • Treatment as usual
Trial OverviewThe study tests if exercising before brain stimulation (tDCS) improves memory in those at risk of cognitive decline after cardiac rehab. It compares the combination of exercise and tDCS against sham stimulation and usual treatment to see which is more effective.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Treatment as usual (exercise education) & tDCSExperimental Treatment2 Interventions
Individuals randomized to this group will receive routine advice about physical activity, and active tDCS.
Group II: Treatment as usual (exercise education) & sham stimulationExperimental Treatment2 Interventions
Individuals randomized to this group will receive routine advice about physical activity, and sham tDCS.
Group III: Exercise primed tDCSExperimental Treatment2 Interventions
Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by active tDCS.
Group IV: Exercise primed Sham stimulationExperimental Treatment2 Interventions
Individuals randomized to this group will receive exercise at University Health Network-Toronto Rehabilitation Institute followed by sham tDCS.

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]
In a study involving 18 chronic stroke patients, bi-hemispheric transcranial direct current stimulation (tDCS) combined with multimodal physical training (MPT) significantly improved motor function and strength compared to sham stimulation, with notable effect sizes in various measures such as Fugl-Meyer scores and peak torque.
The combination of tDCS and MPT led to substantial enhancements in cardiorespiratory capacity and motor performance, indicating that tDCS can effectively optimize rehabilitation outcomes in stroke survivors.
Multimodal physical training combined with tDCS improves physical fitness components in people after stroke: a double-blind randomized controlled trial.Massaferri, R., Montenegro, R., de Freitas Fonseca, G., et al.[2023]
Transcranial direct current stimulation (tDCS) significantly increased the time to exhaustion (TTE) during submaximal running in trained men, with TTE lasting 21.18 minutes under tDCS compared to 18.44 minutes with sham stimulation.
Despite the improvement in exercise duration, tDCS did not affect the perceived exertion or cardiorespiratory responses (like heart rate and oxygen consumption), suggesting that it enhances endurance without altering physiological stress levels during exercise.
Transcranial Direct Current Stimulation of motor cortex enhances running performance.Park, SB., Sung, DJ., Kim, B., et al.[2023]

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]
Multimodal physical training combined with tDCS improves physical fitness components in people after stroke: a double-blind randomized controlled trial. [2023]
Transcranial Direct Current Stimulation of motor cortex enhances running performance. [2023]
Does prefrontal cortex transcranial direct current stimulation influence the oxygen uptake at rest and post-exercise? [2014]
Transcranial Direct Current Stimulation: No Effect on Aerobic Performance, Heart Rate, or Rating of Perceived Exertion in a Progressive Taekwondo-Specific Test. [2023]
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]
A Review of Acute Aerobic Exercise and Transcranial Direct Current Stimulation Effects on Cognitive Functions and Their Potential Synergies. [2023]
Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]
Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Effect of transcranial direct current stimulation on exercise performance: A systematic review and meta-analysis. [2019]
Exercise improves recognition memory and synaptic plasticity in the prefrontal cortex for rats modelling vascular dementia. [2019]
Acute effect of high-definition and conventional tDCS on exercise performance and psychophysiological responses in endurance athletes: a randomized controlled trial. [2023]