Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Neurological Health in Aging Via Neuroplasticity-based Computerized Exercise (INHANCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04149457
Recruitment Status : Not yet recruiting
First Posted : November 4, 2019
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
McGill University
Information provided by (Responsible Party):
Posit Science Corporation

Brief Summary:
This study is a validation study to evaluate efficacy of a neuroplasticity-based, computerized cognitive training program INHANCE (Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise) to improve neurological and neuropsychological health in older adults.

Condition or disease Intervention/treatment Phase
Healthy Aging Other: Computerized Plasticity-Based Adaptive Cognitive Training Other: Commercially available computerized training Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Neurological Health in Aging Via Neuroplasticity-based Computerized Exercise (INHANCE)
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. Stricture and Resting through MRI Imaging [ Time Frame: At 3 months (post-intervention) ]
    Stricture and resting will be observed through MRI Imaging.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Potential participant must be 65+ years old at the time of study screening.
  • Potential participant should achieve a score of ≥ 23 on the Montreal Cognitive Assessment (MoCA).
  • Potential participant must be likely able to compete all primary outcome measures in the judgment of the consenting study staff person.
  • Potential participant must demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in this research study.
  • Potential participant must have the visual, auditory, and motors capacity to use the computerized intervention in the judgment of the consenting study staff person.
  • Potential participant must already have, be willing to obtain, or be willing to travel to locations with WiFi connectivity to complete intervention activities.
  • Potential participant must be a fluent English or French speaker from the age of 12.

Exclusion Criteria:

  • Potential participant should not have an existing diagnosis of major or minor neurocognitive disorder at screening.
  • Potential participants with active suicidal ideation with specific plan and intent or suicide-related behaviors within 2 months of consent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
  • Potential participant should not have a Geriatric Depression Scale (GDS) score of >10.
  • Potential participant should not have been treated within 5 years of the date of consent with a computer-based cognitive training program manufactured by Posit Science.
  • Potential participant should not be participating in a concurrent clinical trial (involving an investigational pharmaceutical, behavioral treatment, medical device or other) that, in the judgment of the Site Principal Investigator, could affect the outcome of this study.
  • Potential participant may not be pregnant and should not have claustrophobia or implantation with any medical devices above the waist that may concentrate radio frequency fields, or have other medical issues that may frustrate participation in MRI imaging procedures.
  • Potential participant should not have medical illnesses deemed to interfere with participation in study activities and/or unstable and/or untreated conditions that may affect cognition, including substance abuse/dependence disorders, drugs that interfere with cholinergic function, ongoing chemotherapy or other cancer treatment.
  • Potential participant who shows signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) will be excluded.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Sawsan Dabit (415) 230-3741 sawsan.dabit@positscience.com
Contact: Sarah-Jane Kim 415-539-3130 sarah-jane.kim@positscience.com

Locations
Layout table for location information
Canada, Quebec
McGill University
Montréal, Quebec, Canada, H3A 2B4
Contact: Lydia Ouellet    (514)-398-1445    lydia.ouellet@mcgill.ca   
Principal Investigator: Etienne de Villers-Sidani, PhD         
Sponsors and Collaborators
Posit Science Corporation
McGill University
Investigators
Layout table for investigator information
Principal Investigator: Thomas Van Vleet, PhD Posit Science Corporation
Principal Investigator: Mouna Attarha, PhD Posit Science Corporation
Layout table for additonal information
Responsible Party: Posit Science Corporation
ClinicalTrials.gov Identifier: NCT04149457    
Other Study ID Numbers: PSC-0903-19
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No