Association of Transcranial Alternating Current Stimulation with Digital Cognitive Training for Cognitive Remediation in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- MONTREAL COGNITIVE ASSESSMENT (MOCA)
研究概览
简要总结
BACKGROUND Cognitive decline in older adults, especially those who develop Mild Cognitive Impairment and Alzheimer's Disease, currently has limited options of pharmacological treatments, with modest efficacy.
Digital Cognitive Training (DCT) and Transcranial Alternating Current Stimulation (tACS) are two promising tools for cognitive remediation in this population. In this exploratory study, we investigate feasibility, tolerability and preliminary effects of the association of both interventions in older adults with cognitive complaints.
METHODS Older adults with cognitive complaints are being enrolled for this study, which comprises 5 daily sessions of 30 minutes of DCT using the BrainHQ platform while simultaneously receiving theta tACS (6Hz, 1.6mA) targeting the Left Dorsolateral Prefrontal Cortex.
详细描述
Our goals in this study are:
- To investigate the feasibility and safety of transcranial direct current stimulation (tDCS) adjunctive to cognitive training (CT) in a cohort of individuals diagnosed with mild cognitive impairment (MCI), Subjective Cognitive Decline or Alzheimer's desease in it's initial phase (CDR 1).
- To assess the efficacy of this combined intervention in modulating cognitive function, as measured by a comprehensive neuropsychological battery.
- To explore the underlying neural mechanisms of this intervention by examining changes in event-related potentials (ERPs), specifically the N200 and P300 components, which are sensitive to cognitive processes and neural plasticity.
- To identify potential peripheral biomarkers in serum that may correlate with cognitive decline and response to the intervention.
- To determine whether the combined intervention can induce lasting changes in neurophysiological markers, as assessed by repeated ERP measurements.
- To examine the relationship between the observed cognitive improvements, alterations in neurophysiological measures, and changes in serum biomarker levels, with the aim of elucidating the biological mechanisms underlying the intervention's effects.
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, Care Provider, Outcomes Assessor)
盲法说明
A random 5 digits password will be given to the care provider. This password will make the stimulation device enter SHAM mode or true stimulation mode, without the care provider or the patient knowing which mode it will be in.
The SHAM mode has the Ramp up and Ramp down periods, so the participant allocated in the control-SHAM group will feel the effects of the eletric current on the scalp for some seconds in the begining and end of each session.
Outcome assessors will also not be informed which group the participant is allocated.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects over 50 years old, with cognitive complaints
排除标准
- •Estimated Intelligence Quotient <80
- •Dependence on psychoactive substances (DSM-V)
- •Severe psychiatric or neurological disorders
- •Uncorrected visual/hearing problems
- •History of syncope for an unexplained reason or seizure less than a year ago
- •Previous stroke
- •Use of anticoagulants
- •Intracranial metallic prosthesis or cardiac pacemaker
- •Any contraindication to performing tACS
研究组 & 干预措施
tACS+DCT
5 daily sessions of 30 minutes of DCT using the BrainHQ platform while simultaneously receiving theta tACS (6Hz, 1.6mA) targeting the Left Dorsolateral Prefrontal Cortex.
干预措施: Transcranial Alternating Current Stimulation (Device)
tACS+DCT
5 daily sessions of 30 minutes of DCT using the BrainHQ platform while simultaneously receiving theta tACS (6Hz, 1.6mA) targeting the Left Dorsolateral Prefrontal Cortex.
干预措施: Digital Cognitive Training (Device)
SHAM+DCT
5 daily sessions of 30 minutes of DCT using the BrainHQ platform while simultaneously receiving stimulation with the device in SHAM mode (with Ramp Up, no current during the session period and Ramp down) targeting the Left Dorsolateral Prefrontal Cortex.
干预措施: Transcranial Alternating Current Stimulation (Device)
SHAM+DCT
5 daily sessions of 30 minutes of DCT using the BrainHQ platform while simultaneously receiving stimulation with the device in SHAM mode (with Ramp Up, no current during the session period and Ramp down) targeting the Left Dorsolateral Prefrontal Cortex.
干预措施: Digital Cognitive Training (Device)
结局指标
主要结局
MONTREAL COGNITIVE ASSESSMENT (MOCA)
时间窗: 1 week after intervention
The MoCA, or Montreal Cognitive Assessment, is a screening tool designed to evaluate global cognitive function, covering domains such as memory, executive function, language, visuospatial abilities, and attention. Scores range from 0 to 30, with higher scores indicating better cognitive performance and a score below 26 often considered indicative of cognitive impairment.
次要结局
- The Rey Auditory Verbal Learning Test (RAVLT)(1 week after intervention)
- Five digits test (FDT)(1 week after intervention)
- Rey-Osterrieth complex figure (ROCF)(1 week after intervention)
- Semantic and phonemic verbal fluency(1 week after intervention)
- Visual P300 (Event-Related Potential)(1 week after intervention)
- Serum GFAP Analysis(before intervention)
- Serum Beta-Amyloid Analysis(before intervention)
- Serum Tau Protein Analysis(before intervention)
- Prosaccade Task (Eye Tracking)(1 week after intervention)
- Antisaccade Task (Eye Tracking)(1 week after intervention)
- Visual Search Task (Eye Tracking):(1 week after intervention)
研究者
Rogerio Panizzutti, MD, PhD
Professor
Universidade Federal do Rio de Janeiro