Speed of Processing (SoP) Training Plus α-tACS

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cognitive Dysfunction, Mild Cognitive Impairment, tACS, Cognitive Training

Intervention / Treatment
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* Device: alpha tACS
* Behavioral: Speed of Processing Training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double-blinded, parallel randomized trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active tACS plus active SoP<br>Active alpha range tACS plus Speed of Processing Training | Device: alpha tACS<br>* 2mA α-tACS (based on the IAF) over the prefrontal cortex (PFC)<br>Behavioral: Speed of Processing Training<br>* 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)<br>|
| Active Comparator: Active tACS plus sham SoP<br>Active alpha range tACS plus sham Speed of Processing Training | Device: alpha tACS<br>* 2mA α-tACS (based on the IAF) over the prefrontal cortex (PFC)<br>|
| Active Comparator: Sham tACS plus active SoP<br>Sham alpha range tACS plus Speed of Processing Training | Behavioral: Speed of Processing Training<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| EEG power in the alpha band | Total Power | Change from baseline to week 3 | 
| EEG power in the alpha band | Total Power | Change from baseline to week 6 | 
| P300 Event related potential - A | Amplitude of the P300 potential | Change from baseline to week 3 | 
| P300 Event related potential - L | Latency of the P300 potential | Change from baseline to week 3 | 
| P300 Event related potential - A | Amplitude of the P300 potential | Change from baseline to week 6 | 
| P300 Event related potential - L | Latency of the P300 potential | Change from baseline to week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MCI, tACS, Cognitive training