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Clinical Trials/NCT06733714
NCT06733714
Recruiting
Not Applicable

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

Universidade Federal do Rio de Janeiro1 site in 1 country40 target enrollmentDecember 2, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Dysfunction
Sponsor
Universidade Federal do Rio de Janeiro
Enrollment
40
Locations
1
Primary Endpoint
MONTREAL COGNITIVE ASSESSMENT (MOCA)
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 2, 2024
End Date
March 1, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rogerio Panizzutti, MD, PhD

Professor

Universidade Federal do Rio de Janeiro

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

Outcomes

Primary Outcomes

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

  • Five digits test (FDT)(1 week after intervention)
  • Rey-Osterrieth complex figure (ROCF)(1 week after intervention)
  • Semantic and phonemic verbal fluency(1 week after intervention)
  • The Rey Auditory Verbal Learning Test (RAVLT)(1 week after intervention)
  • Visual P300 (Event-Related Potential)(1 week after intervention)
  • Serum GFAP Analysis(before intervention)
  • Serum Beta-Amyloid Analysis(before intervention)
  • Serum Tau Protein Analysis(before intervention)
  • Prosaccade Task (Eye Tracking)(1 week after intervention)
  • Antisaccade Task (Eye Tracking)(1 week after intervention)
  • Visual Search Task (Eye Tracking):(1 week after intervention)

Study Sites (1)

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