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

January 24, 2018 updated by: Sheba Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR cognitive tasks + treadmill
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 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".
Active Comparator: VR cognitive tasks - treadmill
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
Sham Comparator: scientific TV documentary + treadmill
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.
Device: treadmill
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".
Behavioral: watching a scientific TV documentary
No Intervention: Passive control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in overall cognition- measured by averaging z-scores from 14 paper and pencil neuropsychological tests covering episodic memory and executive functions cognitive domains.
Time Frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
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)
Time Frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
specific cognitive domains- average of z-scores of paper and pencil memory tests and of executive functions tests
Time Frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
summary of z-scores of executive functions tests and of episodic memory 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
Time Frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
T2*-weighted fMRI during an n-back working memory task; contrasts: 1-back minus 0-back; 2-back minus 0-back; 2-back minus 1-back
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
Time Frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
T2*-weighted fMRI while relaxing with eyes closed; functional connectivity between seed regions of resting state networks (e.g., default mode, attentional, salience) and other regions by correlation of BOLD signal in seed regions with that in other regions
baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
hippocampal volume
Time Frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
3D T1-weighted MRI imaging
baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
frontal inferior cortex volume
Time Frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
3D T1-weighted MRI imaging
baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
white matter hyperintensity (WMH) burden
Time Frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
3D T2-FLAIR MRI imaging
baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
diffusion-tensor imaging (DTI) measures
Time Frame: baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
diffusion-weighted MRI imaging (DWI) to map white matter tractography
baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Michal Schnaider Beeri, PhD, Sheba Medical Center/Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

June 26, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (Estimate)

July 14, 2016

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 24, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-16-2988-MSB-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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