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

Universidade Federal do Rio de Janeiro

Status: Enrolling

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

Treatments: Device: Digital Cognitive Training; Device: Transcranial Alternating Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06733714

38114820.3.0000.5263

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

tACS+DCT

Experimental group

Description:

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.

Treatment:

Device: Transcranial Alternating Current Stimulation

Device: Digital Cognitive Training

SHAM+DCT

Sham Comparator group

Description:

5 daily sessions of 30 minutes of DCT using the BrainHQ platform while simultaneously receiving stimulation with the device in SHAM mode (with Ramp Up, no current during the session period and Ramp down) targeting the Left Dorsolateral Prefrontal Cortex.

Treatment:

Device: Transcranial Alternating Current Stimulation

Device: Digital Cognitive Training