Improving Neurological Health in Aging Via Neuroplasticity-Based Computerized Exercise: Protocol for a Randomized Controlled Trial.
Attarha, M., de Figueiredo Pelegrino, A. C., Toussaint, P. J., Grant, S. J., Van Vleet, T., & de Villers-Sidani, E..
(2024)JMIR research protocols, Canada.
DOI: 10.2196/59705
Abstract
BACKGROUND
Our current understanding of how computerized brain training drives cognitive and functional benefits remains incomplete. This paper describes the protocol for Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise (INHANCE), a randomized controlled trial in healthy older adults designed to evaluate whether brain training improves cholinergic signaling.
OBJECTIVE
INHANCE evaluates whether 2 computerized training programs alter acetylcholine binding using the vesicular acetylcholine transporter ligand [18F] fluoroethoxybenzovesamicol ([18F] FEOBV) and positron emission tomography (PET).
METHODS
In this phase IIb, prospective, double-blind, parallel-arm, active-controlled randomized trial, a minimum of 92 community-dwelling healthy adults aged 65 years and older are randomly assigned to a brain training program designed using the principles of neuroplasticity (BrainHQ by Posit Science) or to an active control program of computer games designed for entertainment (eg, Solitaire). Both programs consist of 30-minute sessions, 7 times per week for 10 weeks (35 total hours), completed remotely at home using either loaned or personal devices. The primary outcome is the change in FEOBV binding in the anterior cingulate cortex, assessed at baseline and posttest. Exploratory cognitive and behavioral outcomes sensitive to acetylcholine are evaluated before, immediately after, and 3 months following the intervention to assess the maintenance of observed effects.
RESULTS
The trial was funded in September 2019. The study received approval from the Western Institutional Review Board in October 2020 with Research Ethics Board of McGill University Health Centre and Health Canada approvals in June 2021. The trial is currently ongoing. The first participant was enrolled in July 2021, enrollment closed when 93 participants were randomized in December 2023, and the trial will conclude in June 2024. The study team will be unblinded to conduct analyses after the final participant exits the study. We expect to publish the results in the fourth quarter of 2024.
CONCLUSIONS
There remains a critical need to identify effective and scalable nonpharmaceutical interventions to enhance cognition in older adults. This trial contributes to our understanding of brain training by providing a potential neurochemical explanation of cognitive benefit.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04149457; https://clinicaltrials.gov/ct2/show/NCT04149457.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/59705.
Aim of study- the ‘Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise’ (INHANCE) study aimed to test whether computerized brain training can improve brain health in older adults by enhancing acetylcholine activity- a chemical important for memory and attention. The randomized controlled trial included 93 healthy adults aged 65 years and older, assigned to either a neuroplasticity-based brain training program (BrainHQ, including “Double Decision” and “Freeze Frame”) or an active control group playing regular computer games (e.g., Solitaire). Participants completed 30-minute sessions, seven days per week, for ten weeks. The primary outcome was change in acetylcholine binding in the anterior cingulate cortex region of the brain (measured via PET scans). Secondary outcomes include changes in cognition, attention, and behaviour assessed before, after, and three months post-training.
Findings- as this study is a study protocol only, outcome data was not yet available. However, the researchers expected that participants who completed the BrainHQ training would show greater acetylcholine binding and improved cognitive function compared with the control group. These changes would provide neurochemical evidence that brain training enhances brain plasticity and cognitive performance in aging.
Strengths- the study featured a rigorous double-blind, randomized controlled design with an active control. It used advanced neuroimaging (FEOBV-PET) to measure acetylcholine levels- a novel biomarker of brain plasticity, along with validated cognitive and behavioural assessments. Moreover, the large well-characterized sample and long follow-up (three months post-intervention) would strengthen the reliability of findings. Lastly, the remote, home-based intervention design also enhanced accessibility of the intervention.
Limitations- being a time-intensive intervention (35 hours over 10 weeks), adherence may have been challenging for older participants. The requirement for internet access and digital literacy may have limited generalizability to less tech-savvy or lower-income populations. Additionally, both intervention and control activities involved computer use, which could reduce contrasts between groups. As a protocol paper, it cannot yet confirm efficacy or long-term cognitive outcomes of the intervention.
Note: Effect sizes could not be calculated for this study with the current CogTale capability.
Aim of study- the ‘Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise’ (INHANCE) study aimed to test whether computerized brain training can improve brain health in older adults by enhancing acetylcholine activity- a chemical important for memory and attention. The randomized controlled trial included 93 healthy adults aged 65 years and older, assigned to either a neuroplasticity-based brain training program (BrainHQ, including “Double Decision” and “Freeze Frame”) or an active control group playing regular computer games (e.g., Solitaire). Participants completed 30-minute sessions, seven days per week, for ten weeks. The primary outcome was change in acetylcholine binding in the anterior cingulate cortex region of the brain (measured via PET scans). Secondary outcomes include changes in cognition, attention, and behaviour assessed before, after, and three months post-training.
Findings- as this study is a study protocol only, outcome data was not yet available. However, the researchers expected that participants who completed the BrainHQ training would show greater acetylcholine binding and improved cognitive function compared with the control group. These changes would provide neurochemical evidence that brain training enhances brain plasticity and cognitive performance in aging.
Strengths- the study featured a rigorous double-blind, randomized controlled design with an active control. It used advanced neuroimaging (FEOBV-PET) to measure acetylcholine levels- a novel biomarker of brain plasticity, along with validated cognitive and behavioural assessments. Moreover, the large well-characterized sample and long follow-up (three months post-intervention) would strengthen the reliability of findings. Lastly, the remote, home-based intervention design also enhanced accessibility of the intervention.
Limitations- being a time-intensive intervention (35 hours over 10 weeks), adherence may have been challenging for older participants. The requirement for internet access and digital literacy may have limited generalizability to less tech-savvy or lower-income populations. Additionally, both intervention and control activities involved computer use, which could reduce contrasts between groups. As a protocol paper, it cannot yet confirm efficacy or long-term cognitive outcomes of the intervention.
Note: Effect sizes could not be calculated for this study with the current CogTale capability.