Improving Neurological Health in Aging Via Neuroplasticity-based Computerized Exercise (INHANCE)
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|ClinicalTrials.gov Identifier: NCT04149457|
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : October 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Healthy Aging||Other: Computerized Plasticity-Based Adaptive Cognitive Training Other: Commercially available computerized training||Not Applicable|
The primary objective of this study is to evaluate the impact of a targeted speed and alertness training program (INHANCE) to improve cognition in healthy older adults, as evidenced by standard measures of cognition, and positive improvements in the neuromodulatory cholinergic system as measured via positron-emission tomography (PET).
The investigators will employ a double-blind, parallel-arm, placebo-controlled, randomized clinical trial design comprised of a treatment group using INHANCE, a computerized program that trains speed of processing and attention, compared to an active control group using computer games in 90 healthy older adults.
Approximately 108 participants will be consented to ensure the successful completion of 90 participants (post 20% attrition). Participants will then complete the Screening (V0) assessments to determine eligibility. Following inclusion, participants will complete the Baseline (V1) assessments, PET imaging and structural MRI scan; participants will then be randomized into either the INHANCE training or Computer Games, and will engage in approximately 35 hours of program use for the 10-week intervention period. Approximately halfway through the intervention period (~5 weeks), participants will complete Interim (V2) assessments to be compared to the Post-Intervention assessments. Following the 10-week intervention, participants will complete a Post-Intervention (V3) assessment and PET imaging to evaluate changes in cognitive function. Participants will then stop using their assigned program for 3 months and return for a Follow-up (V4) end-of-study assessment to evaluate the endurance of changes in cognitive function in the absence of further program use.
The protocol will be conducted in accordance with the protocol submitted to and approved by the National Institute on Health (NIH), and subject to Institutional Review Board review and approval prior to implementation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Improving Neurological Health in Aging Via Neuroplasticity-based Computerized Exercise (INHANCE)|
|Actual Study Start Date :||July 16, 2021|
|Estimated Primary Completion Date :||May 31, 2022|
|Estimated Study Completion Date :||May 31, 2022|
Experimental: Experimental Treatment
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Other: Computerized Plasticity-Based Adaptive Cognitive Training
Thirty minutes of training on computerized exercises that targets visual processing speed, memory, attention and alertness.
Active Comparator: Active Comparator
Commercially available computerized training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Other: Commercially available computerized training
Thirty minutes of training on computerized, casual video games.
- Change in FEOVB uptake through PET Imaging [ Time Frame: At 3 months (post-intervention) ]18F-fluoroethoxybenzovesamicol (FEOBV) uptake as measured through Positron Emission Tomography (PET) ligand imaging.
- Change in EXAMINER Executive Composite Score [ Time Frame: At 3 months (post-intervention) and at 6 months (follow-up) ]The EXAMINER is a computer based battery of executive function tests which yields a total or 'composite' score to represent global executive functioning. Executive composite scores can range from -3.0 to 3.0 with higher scores corresponding to better executive functioning, and negative scores indicating impairment.
- Change in Useful Field of View (UFOV) Score [ Time Frame: At 3 months (post-intervention) and at 6 months (follow-up) ]This is a computerized assessment that serves as a positive control for task learning. A single exposure duration (in milliseconds) required for users to achieve approximately 80% criterion accuracy in identification of central and peripheral targets. The score range is 10ms - 5000ms (lower scores indicate better performance).
- Change in Tonic and Phasic Alertness (TAPAT) Score [ Time Frame: At 0 months (pre-intervention), at 3 months (post-intervention) and at 6 months (follow-up) ]This is a computerized assessment that serves as a positive control for task learning. A single target frequency required for users to achieve at least 80% accuracy in target and foil identification for a pre-specified target image presented among similar foil images. The score range is 1-7 corresponding to 40%, 35%, 30%, 25%, 20%, 15%, and 10% target frequencies (higher scores indicate better performance).
- Change in Heart Rate Variability [ Time Frame: At 3 months (post-intervention) and at 6 months (follow-up) ]Heart rate variability will be measured to determine acetylcholinergic function over time.
- Change in Pupillometry [ Time Frame: At 3 months (post-intervention) and at 6 months (follow-up) ]Pupil dilation will be measured to determine acetylcholinergic function over time.
- Stricture and Resting through MRI Imaging [ Time Frame: At 3 months (post-intervention) ]Stricture and resting will be observed through MRI Imaging.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04149457
|Contact: Sarah-Jane Kimemail@example.com|
|Montréal, Quebec, Canada, H3A 2B4|
|Contact: Martin Chevrier firstname.lastname@example.org|
|Principal Investigator: Etienne de Villers-Sidani, PhD|
|Principal Investigator:||Thomas Van Vleet, PhD||Posit Science Corporation|
|Principal Investigator:||Mouna Attarha, PhD||Posit Science Corporation|