Speed of Processing (SoP) Training Plus α-tACS

Not Applicable

Recruiting

• Conditions: Mild Cognitive Impairment; Cognitive Training; Cognitive Dysfunction; tACS
• Interventions: Device: alpha tACS; Behavioral: Speed of Processing Training

• Registration Number: NCT05198726
• Lead Sponsor: Portucalense University

Brief Summary

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2022-01-06
• Study First Posted: 2022-01-20
• Status Verified: 2022-04
• Study Start: 2022-04-19
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-20
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 327

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tACS plus sham SoP	alpha tACS	Active alpha range tACS plus sham Speed of Processing Training
Active tACS plus active SoP	alpha tACS	Active alpha range tACS plus Speed of Processing Training
Sham tACS plus active SoP	Speed of Processing Training	Sham alpha range tACS plus Speed of Processing Training
Active tACS plus active SoP	Speed of Processing Training	Active alpha range tACS plus Speed of Processing Training

Primary Outcome Measures

Name	Time	Method
Useful Field of View Test (UFOV)	Change from baseline to week 3	UFOV is a measure of the speed of visual processing for rapid detection and localization of targets under conditions of divided visual attention and in the presence and absence of visual clutter at an above chance level (i.e. 75%).
Useful Field of View (UFOV)	Change from baseline to week 6	UFOV is a measure of the speed of visual processing for rapid detection and localization of targets under conditions of divided visual attention and in the presence and absence of visual clutter at an above chance level (i.e. 75%).

Secondary Outcome Measures

Name	Time	Method
EEG power in the alpha band	Change from baseline to week 6	Total Power
Executive Composite Score from the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH EXAMINER)	Change from baseline to week 6	The NIH examiner executive composite comprises cognitive control, verbal fluency, and working memory assessments. Scores are based on the Item Response theory (IRT), which allows for the contribution of each item score is weighted by how effective that item measures that ability in any part of the continuum. Instead of a maximum or a minimum, higher scores, mean better performance.
P300 Event related potential - A	Change from baseline to week 6	Amplitude of the P300 potential
P300 Event related potential - L	Change from baseline to week 6	Latency of the P300 potential

Trial Locations

Locations (1)

Portucalense University; 🇵🇹 Porto, Portugal