About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy subjects over 50 years old, with cognitive complaints
Disqualifiers
Estimated Intelligence Quotient <80
Dependence on psychoactive substances (DSM-V)
Severe psychiatric or neurological disorders
Uncorrected visual/hearing problems
Trial design
Parallel
Treatments tested in this trial
Transcranial Alternating Current Stimulation
DeviceAn alternate eletric current of 1.6mA in theta frequency is applied in the scalp, using two eletrodes (5x5cm). The eletrodes are located aiming for the left dorsolateral prefrontal Cortex area.
Digital Cognitive Training
DeviceUsing a tablet, the participant will do exercises that were designed to stimulate cognitive domains, especially attention and memory. In this case, we use the BrainHQ platform.
Treatment groups
Trial outcomes
Primary outcomes
MONTREAL COGNITIVE ASSESSMENT (MOCA)
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.
Secondary outcomes
Five digits test (FDT)
The FDT assesses attention, processing speed, and executive function. Participants perform tasks involving numerical stimuli under timed conditions. Performance is evaluated based on accuracy and reaction time, with faster and more accurate responses reflecting better cognitive function.
Rey-Osterrieth complex figure (ROCF)
The ROCF evaluates visuospatial constructional abilities, visual memory, and organizational skills. Participants copy a complex figure (copy task) and later reproduce it from memory (recall task). Scores range from 0 to 36, with higher scores representing better performance and lower scores indicating impaired abilities.
Semantic and phonemic verbal fluency
These tasks measure verbal fluency and executive function by asking participants to generate as many words as possible within a category (semantic fluency) or starting with a specific letter (phonemic fluency) within a limited time. Higher scores indicate better fluency and cognitive flexibility, while lower scores suggest deficits in these areas.
The Rey Auditory Verbal Learning Test (RAVLT)
The RAVLT assesses verbal memory, including immediate recall, learning, and delayed recall, as well as susceptibility to interference. Scores vary based on the number of correctly recalled items across trials, with higher scores indicating better memory performance and lower scores reflecting poorer memory function.
Sponsors and contacts
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Universidade Federal do Rio de Janeiro
Lead sponsor
Alzheimer's Association
Collaborator
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Collaborator
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator