Association of Transcranial Alternating Current Stimulation with Digital Cognitive Training for Cognitive Remediation in Older Adults
NCT ID: NCT06733714
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-12-02
2027-03-01
Brief Summary
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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
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* 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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
The SHAM mode has the Ramp up and Ramp down periods, so the participant allocated in the control-SHAM group will feel the effects of the eletric current on the scalp for some seconds in the begining and end of each session.
Outcome assessors will also not be informed which group the participant is allocated.
Study Groups
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tACS+DCT
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.
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.
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.
SHAM+DCT
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
50 Years
ALL
Yes
Sponsors
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Alzheimer's Association
OTHER
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
OTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
Universidade Federal do Rio de Janeiro
OTHER
Responsible Party
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Rogerio Panizzutti, MD, PhD
Professor
Principal Investigators
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Rogerio Panizzutti, Professor
Role: PRINCIPAL_INVESTIGATOR
UFRJ
Locations
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Clínica da Memória - IPUB / UFRJ
Rio de Janeiro, Rio de Janeiro, Brazil
Countries
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Central Contacts
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Facility Contacts
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Brunno Costa, PhD student
Role: primary
Other Identifiers
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38114820.3.0000.5263
Identifier Type: -
Identifier Source: org_study_id