Clinical trial NCT05198726: Speed of Processing (SoP) Training Plus α-tACS
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
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Dysfunction
Mild Cognitive Impairment
tACS
Cognitive Training
Keywords: MCI
tACS
Cognitive training
Lead sponsor: Portucalense University
Sponsor class: OTHER
Collaborators: name: Aveiro University
name: University of Coimbra
First posted: 2022-01-20
Enrollment: 327
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blinded, parallel randomized trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Useful Field of View Test (UFOV)
timeFrame: Change from baseline to week 3
measure: Useful Field of View (UFOV)
timeFrame: Change from baseline to week 6
Secondary outcomes:
measure: Executive Composite Score from the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH EXAMINER)
timeFrame: Change from baseline to week 3
measure: Executive Composite Score from the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH EXAMINER)
timeFrame: Change from baseline to week 6
measure: EEG power in the alpha band
timeFrame: Change from baseline to week 3
measure: EEG power in the alpha band
timeFrame: Change from baseline to week 6
measure: P300 Event related potential - A
timeFrame: Change from baseline to week 3
measure: P300 Event related potential - L
timeFrame: Change from baseline to week 3
measure: P300 Event related potential - A
timeFrame: Change from baseline to week 6
measure: P300 Event related potential - L
timeFrame: Change from baseline to week 6
Other outcomes:
measure: Useful Field of View (UFOV)
timeFrame: Change from baseline to 1 month follow-up (after intervention ended)
measure: Useful Field of View (UFOV)
timeFrame: Change from baseline to 3 months follow-up (after intervention ended)
measure: Useful Field of View (UFOV)
timeFrame: Change from baseline to 6 months follow-up (after intervention ended)
measure: Executive Composite Score from NIH EXAMINER
timeFrame: Change from baseline to 1 month follow-up (after intervention ended)
measure: Executive Composite Score from NIH EXAMINER
timeFrame: Change from baseline to 3 months follow-up (after intervention ended)
measure: Executive Composite Score from NIH EXAMINER
timeFrame: Change from baseline to 6 months follow-up (after intervention ended)
Locations:
city: Porto
country: Portugal
facility: Portucalense University
Study officials:
affiliation: Portucalense University
name: Jorge Leite, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.