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

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ClinicalTrials.gov Identifier: NCT02832921
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

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.

Condition or disease Intervention/treatment
Alzheimer's Disease (AD) Behavioral: cognitive training by virtual reality Behavioral: watching a scientific TV documentary Device: treadmill

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cognitive-motor Intervention Using Virtual Reality for Middle-aged Individuals at High Dementia Risk
Study Start Date : July 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : August 2019


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.
Behavioral: watching a scientific TV documentary 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".
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.



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02832921


Contacts
Contact: Glen M Doniger, PhD Glen.Doniger@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Glen M Doniger, PhD       Glen.Doniger@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Michal Schnaider Beeri, PhD Sheba Medical Center/Icahn School of Medicine at Mount Sinai

Publications:

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02832921     History of Changes
Other Study ID Numbers: SHEBA-16-2988-MSB-CTIL
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sheba Medical Center:
Alzheimer's disease
virtual reality
cognitive training

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders