Cognitive-motor Intervention Using Virtual Reality for Middle-aged Individuals at High Dementia Risk

NCT02832921 | Unknown

• 1 other identifier: SHEBA-16-2988-MSB-CTIL
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this program is to apply a virtual reality (VR) cognitive-motor intervention (compared to active and passive control groups) to delay or slow cognitive decline of middle-aged adults who have a family history of Alzheimer's disease (AD) and thus are at particularly high risk of developing the disease.

Conditions

Alzheimer's Disease (AD)

Keywords

Alzheimer's disease; virtual reality; cognitive training

Outcome Measures

Primary Outcomes (2)

• change in overall cognition- measured by averaging z-scores from 14 paper and pencil neuropsychological tests covering episodic memory and executive functions cognitive domains.

  summary of the z-scores of all 14 paper and pencil cognitive tests

  baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)

• change in cerebral blood flow from arterial spin labeling (ASL)

  acquired by structural MRI using background-suppressed pseudo-continuous ASL (pcASL) featuring a 3D fast spin echo spiral sequence

  baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)

Secondary Outcomes (7)

• specific cognitive domains- average of z-scores of paper and pencil memory tests and of executive functions tests

  baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)

• blood oxygenation level dependent (BOLD) functional MRI (fMRI) signal in the fronto-parietal network associated with working memory

  baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)

• brain resting state functional connectivity by resting state network fMRI BOLD signal correlations

  baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)

• hippocampal volume

  baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)

• frontal inferior cortex volume

  baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)

Study Arms (4)

VR cognitive tasks + treadmill

EXPERIMENTAL

This is the primary group of interest, in which the investigators hypothesize the greatest cognitive gains since motor activity will augment cognitive activity.

Behavioral: cognitive training by virtual reality; Device: treadmill

VR cognitive tasks - treadmill

ACTIVE COMPARATOR

This group will be an active control, receiving the VR cognitive training without treadmill walking, to examine whether the motor component augments the effect of the VR in the experimental group.

Behavioral: cognitive training by virtual reality

scientific TV documentary + treadmill

SHAM COMPARATOR

This group will watch a scientific TV documentary while walking on the treadmill. This control group will permit examination of whether the VR cognitive training, which requires an especially active cognitive effort while walking on the treadmill, is more advantageous than passively watching a scientific TV documentary while performing the same motor task as the experimental group.

Behavioral: watching a scientific TV documentary; Device: treadmill

Passive control

NO INTERVENTION

This group of participants will not receive any intervention but will be assessed with the same battery of assessments as the other three groups, permitting comparisons of the cognitive and neurobiological outcomes of the intervention groups to that of the natural course of decline/deterioration of these at-risk individuals.

Interventions

cognitive training by virtual reality BEHAVIORAL

VR cognitive tasks + treadmill; VR cognitive tasks - treadmill

watching a scientific TV documentary BEHAVIORAL

scientific TV documentary + treadmill

treadmill DEVICE

VR cognitive training will be augmented by walking on a treadmill, since it is well established that dual tasking-i.e. performing the VR-based cognitive effort together with a motor task, even as simple as walking on a treadmill-places greater demand on cognitive resources than a "single task".

VR cognitive tasks + treadmill; scientific TV documentary + treadmill

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participants of the study must have at least one parent with Alzheimer's disease.
• Fluency in Hebrew, in order to understand the instructions of the cognitive tests.
• Availability of an informant for the participant.

You may not qualify if:

• Severe neurological or psychological conditions that may affect cognitive performance.
• Substantial orthopedic limitations which prevent the use of treadmill.
• Unstable medical condition such as an active cancer.
• Incapability of adherence to the training program.
• The participant is undergoing a treatment that may interfere with the study program.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

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MeSH Terms

Conditions

Alzheimer Disease

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Michal Schnaider Beeri, PhD

  Sheba Medical Center/Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Glen M Doniger, PhD

CONTACT

Glen.Doniger@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2016
• First Posted: July 14, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: August 1, 2019
• Last Updated: January 26, 2018

Record last verified: 2018-01

Locations

IL (1)