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The study was halted due to the COVID19, and then due to the lack of funding to continue the study
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| Name | Class |
|---|---|
| Aveiro University | OTHER |
| University of Coimbra | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tACS plus active SoP | Active Comparator | Active alpha range tACS plus Speed of Processing Training |
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| Active tACS plus sham SoP | Active Comparator | Active alpha range tACS plus sham Speed of Processing Training |
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| Sham tACS plus active SoP | Active Comparator | Sham alpha range tACS plus Speed of Processing Training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alpha tACS | Device | 2mA α-tACS (based on the IAF) over the prefrontal cortex (PFC) |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Leite, PhD | Portucalense University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portucalense University | Porto | 4200 - 072 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11514044 | Background | 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. | |
| 35928993 | Derived | 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. |
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Deidentified and coded data will be available to researchers upon request
Data will be available upon study completion.
Upon request.
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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double-blinded, parallel randomized trial
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Sham tACS and cognitive training
| 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) |
|
| 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 |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |