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

Last updated: December 9, 2024
Sponsor: Universidade Federal do Rio de Janeiro
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mild Cognitive Impairment

Alzheimer's Disease

Dementia

Treatment

Digital Cognitive Training

Transcranial Alternating Current Stimulation

Clinical Study ID

NCT06733714
38114820.3.0000.5263
  • Ages > 50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Inclusion

Inclusion Criteria:

  • Healthy subjects over 50 years old, with cognitive complaints

Exclusion

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

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Digital Cognitive Training
Phase:
Study Start date:
December 02, 2024
Estimated Completion Date:
March 01, 2027

Study 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.

Connect with a study center

  • Clínica da Memória - IPUB / UFRJ

    Rio De Janeiro, RJ 22290140
    Brazil

    Active - Recruiting

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