Speed of Processing (SoP) Training Plus α-tACS (aMCIUp)

Portucalense University

Status: Terminated

Conditions: tACS; Mild Cognitive Impairment; Cognitive Training; Cognitive Dysfunction

Treatments: Device: alpha tACS; Behavioral: Speed of Processing Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05198726

UPT01

Details and patient eligibility

About

The current proposal aims to assess if the combination of Speed of Processing (SoP) training with alpha tACS (α-tACS) is able to increase brain speed of processing as assessed by the Useful Field of View (UFOV) when comparing to SoP training plus sham α-tACS. Moreover, a second aim is to assess if those changes in speed of processing transfer to other cognitive domains, such as memory, language and executive functioning. Furthermore, the mechanisms underlying these interventions will be tested, namely to assess brain connectivity and coherence as assessed by EEG. To that purpose, the aim of the current proposal is to conduct a double-blind, parallel randomized trial assessing the effects of combining SoP with alpha endogenous tACS (either active or sham) in participants with Mild Cognitive impairment (MCI).

Full description

Dementia is thought to affect 6.3 million people across Europe and is especially prevalent in people over 85 years old (23.7%). In this sense, several cognitive training programs, alone or in combination with non-invasive brain stimulation have been used in order to ameliorate age-related cognitive impairments, and even to act in a prophylactic manner in order to prevent more extreme deficits, such as the ones presented in mild cognitive impairment, or even dementia.

Despite all these efforts, the effects of CT - combined or not - with several forms of non-invasive brain stimulation have been modest at most.

The current proposal aims to assess if Speed of Processing (SoP) training combined with alpha tACS (α-tACS) increases speed of processing as assessed by the Useful Field of View (UFOV) when comparing to SoP training and sham α-tACS. Furthermore, association betweens changes in speed of processing and changes in other cognitive domains, such as memory, language and executive functioning will be assessed. Finnaly, the current proposal aims at probing the mechanisms underlying these interventions, namely to test brain connectivity and coherence as assessed by EEG.

Enrollment: 40 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Community-dwelling adults aged 65 years and older, with cognitive complains in memory or other functions, which have declined over time

Exclusion criteria

• Score in the mini mental examination less than 23 (or over 28);
• Diagnosis of Alzheimer´s Disease, any other medical condition that may predispose participants for a forthcoming decline in function, or that may increase their risk of mortality during the duration of the study.
• Any contra-indication to tACS, severe sensory losses or communication difficulties that will prevent them from successfully complete the training.
• Had any cognitive training in the past.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 3 patient groups

Active tACS plus active SoP

Active Comparator group

Description:

Active alpha range tACS plus Speed of Processing Training

Treatment:

Behavioral: Speed of Processing Training

Device: alpha tACS

Active tACS plus sham SoP

Active Comparator group

Description:

Active alpha range tACS plus sham Speed of Processing Training

Treatment:

Device: alpha tACS

Sham tACS plus active SoP

Active Comparator group

Description:

Sham alpha range tACS plus Speed of Processing Training

Treatment:

Behavioral: Speed of Processing Training