Speed of Processing (SoP) Training Plus α-tACS

NCT05198726 | Terminated

• 1 other identifier: UPT01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Cognitive Dysfunction; Mild Cognitive Impairment; tACS; Cognitive Training

Keywords

MCI; tACS; Cognitive training

Outcome Measures

Primary Outcomes (2)

• Useful Field of View Test (UFOV)

  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%).

  Change from baseline to week 3

• Useful Field of View (UFOV)

  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%).

  Change from baseline to week 6

Secondary Outcomes (8)

• Executive Composite Score from the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH EXAMINER)

  Change from baseline to week 3

• Executive Composite Score from the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH EXAMINER)

  Change from baseline to week 6

• EEG power in the alpha band

  Change from baseline to week 3

• EEG power in the alpha band

  Change from baseline to week 6

• P300 Event related potential - A

  Change from baseline to week 3

Other Outcomes (6)

• Useful Field of View (UFOV)

  Change from baseline to 1 month follow-up (after intervention ended)

• Useful Field of View (UFOV)

  Change from baseline to 3 months follow-up (after intervention ended)

• Useful Field of View (UFOV)

  Change from baseline to 6 months follow-up (after intervention ended)

Study Arms (3)

Active tACS plus active SoP

ACTIVE COMPARATOR

Active alpha range tACS plus Speed of Processing Training

Device: alpha tACS; Behavioral: Speed of Processing Training

Active tACS plus sham SoP

ACTIVE COMPARATOR

Active alpha range tACS plus sham Speed of Processing Training

Device: alpha tACS

Sham tACS plus active SoP

ACTIVE COMPARATOR

Sham alpha range tACS plus Speed of Processing Training

Behavioral: Speed of Processing Training

Interventions

alpha tACS DEVICE

2mA α-tACS (based on the IAF) over the prefrontal cortex (PFC)

Active tACS plus active SoP; Active tACS plus sham SoP

Speed of Processing Training BEHAVIORAL

SoP training will have a total of four conditions. In condition 1, participants will be asked to identity objects at increasingly brief exposures. For condition 2, identification of stimulus on the center of the screen will be requested from participants, while a second stimulus will appear somewhere in peripheral vision - stimulus duration, difficulty of the central localization task or the area in which targets may be located are used to change the level of difficulty. Condition 3 is similar to condition 2, but visual distractors are added. Finally, for condition 4, an auditory identification component is superimposed over the visual task (Jobe et al., 2001)

Active tACS plus active SoP; Sham tACS plus active SoP

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Portucalense University: lead
• Aveiro University: collaborator
• University of Coimbra: collaborator

Study Sites (1)

Portucalense University

Porto, 4200 - 072, Portugal

Location

Related Publications (2)

• Jobe JB, Smith DM, Ball K, Tennstedt SL, Marsiske M, Willis SL, Rebok GW, Morris JN, Helmers KF, Leveck MD, Kleinman K. ACTIVE: a cognitive intervention trial to promote independence in older adults. Control Clin Trials. 2001 Aug;22(4):453-79. doi: 10.1016/s0197-2456(01)00139-8.

  PMID: 11514044 BACKGROUND

• Leite J, Goncalves OF, Carvalho S. Speed of Processing (SoP) Training Plus alpha-tACS in People With Mild Cognitive Impairment: A Double Blind, Parallel, Placebo Controlled Trial Study Protocol. Front Aging Neurosci. 2022 Jul 14;14:880510. doi: 10.3389/fnagi.2022.880510. eCollection 2022.

  PMID: 35928993 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jorge Leite, PhD

  Portucalense University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Sham tACS and cognitive training
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double-blinded, parallel randomized trial

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 20, 2022
• Study Start: April 19, 2022
• Primary Completion: September 5, 2025
• Study Completion: September 5, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data will be available upon study completion.
• Access Criteria: Upon request.

Locations

PT (1)