Exercise Augmenting Cognition tDCS (EXACT): A Pilot Study of a Combined Exercise and Transcranial Direct Current Stimulation Intervention for Cognition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Alzheimer's Disease Assessment Scale Cog (ADAS-Cog) - Word Recognition Task errors at study endpoint (T3)
研究概览
简要总结
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.
详细描述
Objectives: To assess the efficacy of a combined exercise and tDCS treatment for improving cognitive outcomes in mild cognitive impairment and mild Alzheimer's disease.
Study Design: Eligible participants will be randomized to one of three interventions: Exercise and tDCS, Treatment as usual (TAU/exercise education) and tDCS, or Exercise and sham tDCS. Participants randomized to an exercise group will undergo exercise, followed by either sham or active tDCS. Participants randomized to TAU will receive written information in accordance with the Canadian Physical Activity Guidelines for older adults and tDCS for the same duration. Cognition, neuropsychiatric symptoms and blood samples for biomarker analysis will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The research personnel that will be administering the cognitive assessments will be blinded to treatment allocation. The patients will be blinded to stimulation type.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ≥50 years of age
- •DSM-5 criteria for major or mild neurocognitive disorder due to AD or mixed AD/vascular disease
- •Mild severity of impairment (standardized Mini-Mental State Examination (MMSE) score ≥19)
- •Read and communicate in English
排除标准
- •Change in cognitive enhancing medications (ChEIs and/or memantine) less than 3 months prior to study screen
- •Change in anticonvulsants or psychotropic medications less than 1 month prior to study screen
- •Currently taking benzodiazepines
- •Presence of metal implants that would preclude safe use of tDCS (e.g. pace-maker)
- •Significant neurological condition (e.g. epilepsy, Parkinson's disease, multiple sclerosis)
- •Current psychiatric disorders (e.g. schizophrenia, bipolar disorder, depression, psychosis) or current substance use disorder
- •Medical contraindications to increasing activity level according to the Canadian Society of Exercise Physiology Questionnaire
研究组 & 干预措施
Exercise and tDCS
Patients randomized to this group will attend Toronto Rehabilitation Institute - University Health Network (TRI-UHN) for an individualized exercise program and active tDCS intervention.
干预措施: tDCS (Other)
Exercise and tDCS
Patients randomized to this group will attend Toronto Rehabilitation Institute - University Health Network (TRI-UHN) for an individualized exercise program and active tDCS intervention.
干预措施: Exercise (Other)
Exercise Education and tDCS
Patients randomized to this group will undergo treatment as usual, receiving routine advice about physical activity and active tDCS intervention.
干预措施: tDCS (Other)
Exercise Education and tDCS
Patients randomized to this group will undergo treatment as usual, receiving routine advice about physical activity and active tDCS intervention.
干预措施: Exercise Education (Other)
Exercise and Sham tDCS
Patients randomized to this group will attend TRI-UHN for an individualized exercise program and sham tDCS intervention.
干预措施: Exercise (Other)
Exercise and Sham tDCS
Patients randomized to this group will attend TRI-UHN for an individualized exercise program and sham tDCS intervention.
干预措施: Sham tDCS (Other)
结局指标
主要结局
Alzheimer's Disease Assessment Scale Cog (ADAS-Cog) - Word Recognition Task errors at study endpoint (T3)
时间窗: Study endpoint (two-weeks post baseline)
Assess recognition memory. Words incorrectly recognized will be tallied. Word Recognition scores range from 0 to 12. Higher scores represent a worse outcome.
次要结局
- n-back reaction time at study endpoint (T3)(Study endpoint (two-weeks post baseline))
- Alzheimer's Disease Assessment Scale-Cog (ADAS-Cog) - Word Recall Task at study endpoint (T3)(Study endpoint (two-weeks post baseline))
- The Montreal Cognitive Assessment (MoCA) Total at study endpoint (T3)(Study endpoint (two-weeks post baseline))
- The Neuropsychiatric Inventory (NPI) at study endpoint (T3)(Study endpoint (two-weeks post baseline))