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AgingNCT03293823

HARP-Project 1 Cognitive Training

A study testing VSOP training in people with Aging and Social Isolation, run by University of Rochester at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Emerging evidence from social neuroscience suggests that prefrontal cortex (PFC), insular and anterior cingulate cortex (ACC) regulate social and emotional responses to acute threats to social connectedness among young adults. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Aging, Social Isolation
What is being tested?
VSOP training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
4 sitesUnited States
Study dates
4 Oct 2017to 14 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • aged ≥ 60 years, community-dwelling, English-speaking, adequate vision and hearing for testing, capacity to give consent based on clinician assessment;
  • Telephone Interview for Cognitive Status (TICS) ≥ 31, Geriatric Depression Scale < 7 (i.e., free of major depression that can interfere with neural efficiency for social-emotional regulation), EXAMINER composite score (a comprehensive executive function battery test package that is sensitive to frontal regions' neural efficiency change) < .70 (i.e., reflecting decreased neural efficiency of frontal regions compared to cognitively health older adults in general);
  • moderate social relation difficulties: identified by World Health Organization Disability Assessment Scale (WHO-DAS), "Getting Along with Other People" domain, at least "moderate" difficulties endorsed; from HARP Database Project screening)

Who cannot join

  • a self-report clinical diagnosis of dementia or mild cognitive impairment;
  • MRI contraindications (e.g., pacemaker, metallic implant, claustrophobia);

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • The Northfield

    Fairport, New York, 14450

  • The Highlands

    Pittsford, New York, 14534

  • River Edge Manor

    Rochester, New York, 14620

  • St. Johns Meadows

    Rochester, New York, 14620

Other trials in United States

About this study

Emerging evidence from social neuroscience suggests that prefrontal cortex (PFC), insular and anterior cingulate cortex (ACC) regulate social and emotional responses to acute threats to social connectedness among young adults. Deficient neural reserve or overused neural compensation resulting from neurodegeneration is commonly observed in these frontal regions in old age. This aging-related "neural depletion" may have implications for how older adults respond to social threats, potentially increasing maladaptive emotional and social behavioral responses, such as social anxiety and social avoidance, which contribute to social disconnectedness. The central hypothesis is that cognitive deficits and associated aging-related 'neural depletion' in the frontal regions will contribute to maladaptive social-emotional responses to a social stressor -- social exclusion. Ultimately, maladaptive responses to acute social stress, such as social anxiety and avoidance, can compromise social connectedness by increasing social strain and isolation. The investigators have recently developed a neuroplasticity-based cognitive training program, called vision-based speed of processing (VSOP) training, targeting multiple aspects of cognitive capacity (e.g., attention, working memory and inhibition) and incorporating the speed component to improve the efficiency of these cognitive processes. VSOP training also targets several neural networks seeded in ACC and insular (default mode network) or PFC (the frontal-striatal network and central executive network). These networks also overlap with neural substrates of emotion regulation. Notably, VSOP training appears to improve emotion regulation, as depressive symptoms were reduced in older adults following VSOP training. Finally, the autonomic nervous system (ANS), critical to stress adaptation, is regulated by these frontal regions. The objective of the proposed pilot study is to provide proof-of-concept for the hypothesis that improvements in older adults' cognitive capacity, frontal regions' neural efficiency, and ANS function via the VSOP training will be associated with more adaptive social-emotional response to social exclusion, which, in turn, should confer longer-term protection for older adults' sense of social connectedness. Randomized Controlled Trial Design: 30 older adults will be randomly assigned to engage in 6-week VSOP training, or to an active control group. Differential changes from baseline to post-training in cognitive capacity, neural efficiency, and ANS function, and sense of social connectedness, will be compared between VSOP control groups. A social exclusion paradigm ('cyberball' task) will be conducted post-training to evaluate VSOP training effects on social-emotional responses to social exclusion, including anxiety and motivation for social affiliation.

Being tested
VSOP training, MLA control
Medical subject headings
Social Isolation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VSOP trainingBehavioural

    a computerized cognitive training of attention and processing speed

  • MLA controlBehavioural

    a computerized cognitive intervention of multiple mental leisure activities

Study groups in NCT03293823
Study groupRoleWhat they receive
vision-based speed of processing (VSOP) cognitive trainingExperimentaluse the INSIGHT online program (Posit Science), which includes five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
Receives: Behavioral: VSOP training
active controlActive comparatorThe standardized computerized leisure activities program - MLA, including crossword puzzle, Sudoku, etc. will be used
Receives: Behavioral: MLA control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cognitive capacity

    change of executive function from baseline to 7 week post-training

    Measured: baseline and 7 week post-training

Secondary outcomes (3)
  1. brain function 1 (BOLD fMRI)

    brain functional change in response to social scenario task from baseline to 7 week post-training

    Measured: baseline and 7 week post-training

  2. social well-being

    change of social well-being measured by HARP Social Connectedness and Well-Being Core Battery from baseline to 7 week

    Measured: baseline and 7 week post-training

  3. brain function 2 (BOLD fMRI)

    brain functional adaptability to cyberball task

    Measured: 7 week post-training only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2017
  2. Study start4 Oct 2017
  3. Primary completion14 Dec 2018
  4. Study completion14 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
6-week cognitive training group vs. an active control group
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03293823
Sponsor's protocol ID
RSRB00067540
Status last verified
Jul 2019
First submitted
18 Sep 2017
Last updated
5 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing VSOP training in people with Aging and Social Isolation, run by University of Rochester at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cognitive capacity (time frame: baseline and 7 week post-training). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.

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