Cognitive DysfunctionaMCIUpNCT05198726
Speed of Processing (SoP) Training Plus α-tACS
A study testing alpha tACS and Speed of Processing Training in people with Cognitive Dysfunction and Mild Cognitive Impairment, run by Portucalense University at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Dysfunction, Mild Cognitive Impairment, tACS
- What is being tested?
- alpha tACS and Speed of Processing Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 19 Apr 2022to 5 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Community-dwelling adults aged 65 years and older, with cognitive complains in memory or other functions, which have declined over time
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Being tested
- alpha tACS, Speed of Processing Training
- Keywords
- MCI, tACS, Cognitive training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alpha tACSDevice
2mA α-tACS (based on the IAF) over the prefrontal cortex (PFC)
Speed of Processing TrainingBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Active tACS plus active SoP | Active comparator | Active alpha range tACS plus Speed of Processing Training Receives: 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 Receives: Device: alpha tACS |
| Sham tACS plus active SoP | Active comparator | Sham alpha range tACS plus Speed of Processing Training Receives: Behavioral: Speed of Processing Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 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%).
Measured: 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)
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.
Measured: 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.
Measured: Change from baseline to week 6
EEG power in the alpha band
Total Power
Measured: Change from baseline to week 3
EEG power in the alpha band
Total Power
Measured: Change from baseline to week 6
P300 Event related potential - A
Amplitude of the P300 potential
Measured: Change from baseline to week 3
P300 Event related potential - L
Latency of the P300 potential
Measured: Change from baseline to week 3
P300 Event related potential - A
Amplitude of the P300 potential
Measured: Change from baseline to week 6
P300 Event related potential - L
Latency of the P300 potential
Measured: Change from baseline to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start19 Apr 2022
- Primary completion5 Sep 2025
- Study completion5 Sep 2025
Why it stopped: The study was halted due to the COVID19, and then due to the lack of funding to continue the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blinded, parallel randomized trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portucalense University
- Sponsor type
- University, hospital or other
- Collaborators
- Aveiro University, University of Coimbra
- Responsible party
- Sponsor
- Investigators
- Jorge Leite, PhD, Principal investigator, Portucalense University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198726
- Sponsor's protocol ID
- UPT01
- Acronym
- aMCIUp
- Status last verified
- Sep 2025
- First submitted
- 20 Dec 2021
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified and coded data will be available to researchers upon request
Publications
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.
PubMed 11514044Leite 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.
PubMed 35928993
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05198726
- Acronym / sponsor ID
- aMCIUp / UPT01
- Keywords
- MCI, tACS, Cognitive training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was halted due to the COVID19, and then due to the lack of funding to continue the study
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Portucalense UniversityUniversity, hospital or other
- Collaborators
- Aveiro University, University of Coimbra
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- double-blinded, parallel randomized trial
| Arm | Type | Receives |
|---|---|---|
| Active tACS plus active SoP | Active comparator | Device: alpha tACS, Behavioral: Speed of Processing TrainingActive alpha range tACS plus Speed of Processing Training |
| Active tACS plus sham SoP | Active comparator | Device: alpha tACSActive alpha range tACS plus sham Speed of Processing Training |
| Sham tACS plus active SoP | Active comparator | Behavioral: Speed of Processing TrainingSham alpha range tACS plus Speed of Processing Training |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Community-dwelling adults aged 65 years and older, with cognitive complains in memory or other functions, which have declined over time
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alpha tACS2mA α-tACS (based on the IAF) over the prefrontal cortex (PFC) | Device | Active tACS plus active SoP, Active tACS plus sham SoP |
| Speed of Processing TrainingSoP 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) | Behavioural | Active tACS plus active SoP, Sham tACS plus active SoP |
Primary outcome
Useful Field of View Test (UFOV)
Time frame: Change from baseline to week 3
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)
Time frame: Change from baseline to week 6
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%).
8 secondary outcomes
Executive Composite Score from the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH EXAMINER)
Time frame: Change from baseline to week 3
Executive Composite Score from the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH EXAMINER)
Time frame: Change from baseline to week 6
EEG power in the alpha band
Time frame: Change from baseline to week 3
EEG power in the alpha band
Time frame: Change from baseline to week 6
P300 Event related potential - A
Time frame: Change from baseline to week 3
P300 Event related potential - L
Time frame: Change from baseline to week 3
P300 Event related potential - A
Time frame: Change from baseline to week 6
P300 Event related potential - L
Time frame: Change from baseline to week 6
Results and safety
The study was stopped early (reason given: The study was halted due to the COVID19, and then due to the lack of funding to continue the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Background: PubMed 11514044Jobe 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.
- Derived from this study: PubMed 35928993Leite 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.
- Individual participant dataSharing planned: Yes. Deidentified and coded data will be available to researchers upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Leite, PhD principal investigator
Portucalense University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alpha tACS and Speed of Processing Training in people with Cognitive Dysfunction and Mild Cognitive Impairment, run by Portucalense University at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was halted due to the COVID19, and then due to the lack of funding to continue the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Useful Field of View Test (UFOV) (time frame: Change from baseline to week 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05198726, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.