Association of Transcranial Alternating Current Stimulation with Digital Cognitive Training for Cognitive Remediation in Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial Alternating Current Stimulation, Digital Cognitive Training.
- Who it may be relevant to
- Registry conditions: Cognitive Dysfunction, Alzheimer Disease, Mild Cognitive Impairment, Cognitive Decline. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Interventions
- Device Transcranial Alternating Current Stimulation
An 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. - Device Digital Cognitive Training
Using 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.
Primary outcome measures
- MONTREAL COGNITIVE ASSESSMENT (MOCA) [Time frame: 1 week after intervention]
Secondary outcome measures (11)
- Five digits test (FDT) [Time frame: 1 week after intervention]
- Rey-Osterrieth complex figure (ROCF) [Time frame: 1 week after intervention]
- Semantic and phonemic verbal fluency [Time frame: 1 week after intervention]
- The Rey Auditory Verbal Learning Test (RAVLT) [Time frame: 1 week after intervention]
- Visual P300 (Event-Related Potential) [Time frame: 1 week after intervention]
- Serum GFAP Analysis [Time frame: before intervention]
- Serum Beta-Amyloid Analysis [Time frame: before intervention]
- Serum Tau Protein Analysis [Time frame: before intervention]
- Prosaccade Task (Eye Tracking) [Time frame: 1 week after intervention]
- Antisaccade Task (Eye Tracking) [Time frame: 1 week after intervention]
- Visual Search Task (Eye Tracking): [Time frame: 1 week after intervention]
Eligibility criteria
Inclusion criteria
- Healthy subjects over 50 years old, with cognitive complaints
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Clínica da Memória - IPUB / UFRJ — Rio de Janeiro
Identifiers
NCT: NCT06733714 · 38114820.3.0000.5263