Clinical Trials Directory

Trials / Terminated

TerminatedNCT05198726

Speed of Processing (SoP) Training Plus α-tACS

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Portucalense University · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEalpha tACS2mA α-tACS (based on the IAF) over the prefrontal cortex (PFC)
BEHAVIORALSpeed 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)

Timeline

Start date
2022-04-19
Primary completion
2025-09-05
Completion
2025-09-05
First posted
2022-01-20
Last updated
2025-09-12

Locations

1 site across 1 country: Portugal

Source: ClinicalTrials.gov record NCT05198726. Inclusion in this directory is not an endorsement.