Speed of Processing (SoP) Training Plus α-tACS

Mild Cognitive Impairment Clinical Trial

— aMCIUp  

Official title:

Speed of Processing (SoP) Training Plus α-tACS in People With Mild Cognitive Impairment: a Double Blind, Parallel, Placebo Controlled Trial Study Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05198726
• Other study ID #: UPT01
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2022
• Est. completion date: June 2025

Study information

• Verified date: April 2022
• Source: Portucalense University
• Contact: Jorge Leite, PhD
• Phone: +351225572685
• Email: jorgel[@]upt.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 327
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Training
• Mild Cognitive Impairment

Intervention

Device:
• alpha tACS
2mA a-tACS (based on the IAF) over the prefrontal cortex (PFC)

Behavioral:
• Speed of Processing Training
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)

Locations

Country	Name	City	State
Portugal	Portucalense University	Porto

Sponsors (3)

Lead Sponsor	Collaborator
Portucalense University	Aveiro University, University of Coimbra

Country where clinical trial is conducted

Portugal, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Useful Field of View (UFOV)	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 1 month follow-up (after intervention ended)
Other	Useful Field of View (UFOV)	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 3 months follow-up (after intervention ended)
Other	Useful Field of View (UFOV)	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 6 months follow-up (after intervention ended)
Other	Executive Composite Score from NIH EXAMINER	The NIH examiner comprises cognitive control, verbal fluency, and working memory assessments	Change from baseline to 1 month follow-up (after intervention ended)
Other	Executive Composite Score from NIH EXAMINER	The NIH examiner comprises cognitive control, verbal fluency, and working memory assessments	Change from baseline to 3 months follow-up (after intervention ended)
Other	Executive Composite Score from NIH EXAMINER	The NIH examiner comprises cognitive control, verbal fluency, and working memory assessments	Change from baseline to 6 months follow-up (after intervention ended)
Primary	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
Primary	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	Executive Composite Score from the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH EXAMINER)	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.	Change from baseline to week 3
Secondary	Executive Composite Score from the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH EXAMINER)	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.	Change from baseline to week 6
Secondary	EEG power in the alpha band	Total Power	Change from baseline to week 3
Secondary	EEG power in the alpha band	Total Power	Change from baseline to week 6
Secondary	P300 Event related potential - A	Amplitude of the P300 potential	Change from baseline to week 3
Secondary	P300 Event related potential - L	Latency of the P300 potential	Change from baseline to week 3
Secondary	P300 Event related potential - A	Amplitude of the P300 potential	Change from baseline to week 6
Secondary	P300 Event related potential - L	Latency of the P300 potential	Change from baseline to week 6