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Speed of Processing (SoP) Training Plus α-tACS (aMCIUp)

Primary Purpose

Cognitive Dysfunction, Mild Cognitive Impairment, tACS

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
alpha tACS
Speed of Processing Training
Sponsored by
Portucalense University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Dysfunction focused on measuring MCI, tACS, Cognitive training

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Portucalense UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Active tACS plus active SoP

Active tACS plus sham SoP

Sham tACS plus active SoP

Arm Description

Active alpha range tACS plus Speed of Processing Training

Active alpha range tACS plus sham Speed of Processing Training

Sham alpha range tACS plus Speed of Processing Training

Outcomes

Primary Outcome Measures

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%).
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%).

Secondary Outcome Measures

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.
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.
EEG power in the alpha band
Total Power
EEG power in the alpha band
Total Power
P300 Event related potential - A
Amplitude of the P300 potential
P300 Event related potential - L
Latency of the P300 potential
P300 Event related potential - A
Amplitude of the P300 potential
P300 Event related potential - L
Latency of the P300 potential

Full Information

First Posted
December 20, 2021
Last Updated
April 19, 2022
Sponsor
Portucalense University
Collaborators
Aveiro University, University of Coimbra
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1. Study Identification

Unique Protocol Identification Number
NCT05198726
Brief Title
Speed of Processing (SoP) Training Plus α-tACS
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Portucalense University
Collaborators
Aveiro University, University of Coimbra

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction, Mild Cognitive Impairment, tACS, Cognitive Training
Keywords
MCI, tACS, Cognitive training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double-blinded, parallel randomized trial
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Sham tACS and cognitive training
Allocation
Randomized
Enrollment
327 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tACS plus active SoP
Arm Type
Active Comparator
Arm Description
Active alpha range tACS plus Speed of Processing Training
Arm Title
Active tACS plus sham SoP
Arm Type
Active Comparator
Arm Description
Active alpha range tACS plus sham Speed of Processing Training
Arm Title
Sham tACS plus active SoP
Arm Type
Active Comparator
Arm Description
Sham alpha range tACS plus Speed of Processing Training
Intervention Type
Device
Intervention Name(s)
alpha tACS
Intervention Description
2mA α-tACS (based on the IAF) over the prefrontal cortex (PFC)
Intervention Type
Behavioral
Intervention Name(s)
Speed of Processing Training
Intervention Description
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)
Primary Outcome Measure Information:
Title
Useful Field of View Test (UFOV)
Description
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%).
Time Frame
Change from baseline to week 3
Title
Useful Field of View (UFOV)
Description
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%).
Time Frame
Change from baseline to week 6
Secondary Outcome Measure Information:
Title
Executive Composite Score from the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH EXAMINER)
Description
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.
Time Frame
Change from baseline to week 3
Title
Executive Composite Score from the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH EXAMINER)
Description
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.
Time Frame
Change from baseline to week 6
Title
EEG power in the alpha band
Description
Total Power
Time Frame
Change from baseline to week 3
Title
EEG power in the alpha band
Description
Total Power
Time Frame
Change from baseline to week 6
Title
P300 Event related potential - A
Description
Amplitude of the P300 potential
Time Frame
Change from baseline to week 3
Title
P300 Event related potential - L
Description
Latency of the P300 potential
Time Frame
Change from baseline to week 3
Title
P300 Event related potential - A
Description
Amplitude of the P300 potential
Time Frame
Change from baseline to week 6
Title
P300 Event related potential - L
Description
Latency of the P300 potential
Time Frame
Change from baseline to week 6
Other Pre-specified Outcome Measures:
Title
Useful Field of View (UFOV)
Description
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%).
Time Frame
Change from baseline to 1 month follow-up (after intervention ended)
Title
Useful Field of View (UFOV)
Description
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%).
Time Frame
Change from baseline to 3 months follow-up (after intervention ended)
Title
Useful Field of View (UFOV)
Description
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%).
Time Frame
Change from baseline to 6 months follow-up (after intervention ended)
Title
Executive Composite Score from NIH EXAMINER
Description
The NIH examiner comprises cognitive control, verbal fluency, and working memory assessments
Time Frame
Change from baseline to 1 month follow-up (after intervention ended)
Title
Executive Composite Score from NIH EXAMINER
Description
The NIH examiner comprises cognitive control, verbal fluency, and working memory assessments
Time Frame
Change from baseline to 3 months follow-up (after intervention ended)
Title
Executive Composite Score from NIH EXAMINER
Description
The NIH examiner comprises cognitive control, verbal fluency, and working memory assessments
Time Frame
Change from baseline to 6 months follow-up (after intervention ended)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge Leite, PhD
Phone
+351225572685
Email
jorgel@upt.pt
First Name & Middle Initial & Last Name or Official Title & Degree
Reitoria UPT
Phone
+351225572000
Email
reitoria@upt.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Leite, PhD
Organizational Affiliation
Portucalense University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Portucalense University
City
Porto
ZIP/Postal Code
4200 - 072
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Leite, PhD
Phone
00351225572000
Email
jorgel@upt.pt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified and coded data will be available to researchers upon request
IPD Sharing Time Frame
Data will be available upon study completion.
IPD Sharing Access Criteria
Upon request.
Citations:
PubMed Identifier
11514044
Citation
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.
Results Reference
background
PubMed Identifier
35928993
Citation
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.
Results Reference
derived

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Speed of Processing (SoP) Training Plus α-tACS

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