NCT06733714

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Universidade Federal do Rio de Janeiro · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Cognitive Dysfunction
• Alzheimer Disease
• Mild Cognitive Impairment
• Cognitive Decline
• Frontotemporal Degeneration
• Dementia
• Dementia, Vascular
• Lewy Body Disease
• Beta-Amyloid
• GFAP
• Tau Protein

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-02
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2024-12-13
• Last updated: 2024-12-13

Locations

1 site across 1 country: Brazil