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NCT Number: NCT06733714

Association of Transcranial Alternating Current Stimulation with Digital Cognitive Training for Cognitive Remediation in Older Adults

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Alternating Current Stimulation

Device

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.

Digital Cognitive Training

Device

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 outcomes

  1. MONTREAL COGNITIVE ASSESSMENT (MOCA)

    Time frame: 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.

Secondary outcomes

  1. Five digits test (FDT)

    Time frame: 1 week after intervention

    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.

  2. Rey-Osterrieth complex figure (ROCF)

    Time frame: 1 week after intervention

    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.

  3. Semantic and phonemic verbal fluency

    Time frame: 1 week after intervention

    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.

  4. The Rey Auditory Verbal Learning Test (RAVLT)

    Time frame: 1 week after intervention

    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.

  5. Visual P300 (Event-Related Potential)

    Time frame: 1 week after intervention

    The P300 is an electrophysiological measure of cognitive processing, typically recorded using EEG during an oddball paradigm. It reflects attention and working memory processes, with shorter latencies and higher amplitudes indicating more efficient neural processing and longer latencies or reduced amplitudes suggesting impairment.

  6. Serum GFAP Analysis

    Time frame: before intervention

    Glial fibrillary acidic protein (GFAP) is a biomarker of astrocytic activation and neuroinflammation. Higher serum GFAP levels may indicate glial activation or neurodegeneration, while lower levels are associated with normal brain health.

  7. Serum Beta-Amyloid Analysis

    Time frame: before intervention

    This analysis quantifies beta-amyloid peptides, key biomarkers of Alzheimer's disease pathology. Elevated beta-amyloid levels or an altered ratio of amyloid-beta 42/40 in serum may reflect early neurodegenerative processes, while normal levels are indicative of typical brain function.

  8. Serum Tau Protein Analysis

    Time frame: before intervention

    Serum tau protein levels reflect axonal injury or neurodegeneration. Elevated tau concentrations may indicate pathological processes such as Alzheimer's disease or other neurodegenerative disorders, while normal levels suggest no significant axonal damage.

  9. Prosaccade Task (Eye Tracking)

    Time frame: 1 week after intervention

    This task evaluates basic saccadic eye movement control. Participants are instructed to fixate on a peripheral target as it appears. Key metrics include reaction time, accuracy, and velocity of saccades, with faster and more accurate responses indicating better ocular motor control.

  10. Antisaccade Task (Eye Tracking)

    Time frame: 1 week after intervention

    This task assesses inhibitory control and executive function. Participants must suppress a reflexive saccade to a peripheral target and instead look in the opposite direction. Metrics such as error rates, reaction times, and corrected errors are analyzed, with fewer errors and faster reaction times indicating better inhibitory control and executive function.

  11. Visual Search Task (Eye Tracking):

    Time frame: 1 week after intervention

    This task evaluates visual attention and search efficiency. Participants identify a target among distractors under varying levels of complexity. Performance is measured by reaction time and accuracy, with faster and more precise responses indicating better attentional control and visual search ability.

Study contacts

Contact information is provided by the study sponsor or research team.

Brunno Costa, PhD student

CONTACT

[email protected]

+55 31996773008

Rogerio Panizzutti, Professor

CONTACT

[email protected]

+55:21-3938-5588

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Collaborators

  • Alzheimer's Association
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 13, 2024
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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