Clinical trial NCT06733714: Association of Transcranial Alternating Current Stimulation with Digital Cognitive Training for Cognitive Remediation in Older Adults
Official title: Association of Transcranial Alternating Current Stimulation with Digital Cognitive Training for Cognitive Remediation in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Dysfunction
Alzheimer Disease
Mild Cognitive Impairment
Cognitive Decline
Frontotemporal Degeneration
Dementia
Dementia, Vascular
Lewy Body Disease
Beta-Amyloid
GFAP
Tau Protein
Keywords: tacs
nibs
transcranial alternate current stimulation
mild cognitive impairment
MCI
ALzheimer
Cognition
Elderly
Older Adults
Cognitive enhancement
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2024-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: MONTREAL COGNITIVE ASSESSMENT (MOCA)
timeFrame: 1 week after intervention
Secondary outcomes:
measure: Five digits test (FDT)
timeFrame: 1 week after intervention
measure: Rey-Osterrieth complex figure (ROCF)
timeFrame: 1 week after intervention
measure: Semantic and phonemic verbal fluency
timeFrame: 1 week after intervention
measure: The Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: 1 week after intervention
measure: Visual P300 (Event-Related Potential)
timeFrame: 1 week after intervention
measure: Serum GFAP Analysis
timeFrame: before intervention
measure: Serum Beta-Amyloid Analysis
timeFrame: before intervention
measure: Serum Tau Protein Analysis
timeFrame: before intervention
measure: Prosaccade Task (Eye Tracking)
timeFrame: 1 week after intervention
measure: Antisaccade Task (Eye Tracking)
timeFrame: 1 week after intervention
measure: Visual Search Task (Eye Tracking):
timeFrame: 1 week after intervention
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Clínica da Memória - IPUB / UFRJ
state: RJ
Study officials:
affiliation: UFRJ
name: Rogerio Panizzutti, Professor
role: PRINCIPAL_INVESTIGATOR
References: