We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified July 2017 by Sheba Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02832921
First Posted: July 14, 2016
Last Update Posted: July 17, 2017
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.
Information provided by (Responsible Party):
Sheba Medical Center
  Purpose
The primary objective of this program is to apply a virtual reality (VR) cognitive-motor rehabilitation program 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 Intervention
Alzheimer's Disease (AD) Behavioral: cognitive training by virtual reality Behavioral: watching a tv series about the brain Device: treadmill

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cognitive-motor Rehabilitation Program Using Virtual Reality for Middle-aged Individuals at High Dementia Risk

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • overall cognition- measured by the sum of the z-scores of 15 paper and pencil neuropsychological tests covering episodic memory and executive functions cognitive domains. [ Time Frame: from the baseline until the end of the training duration of 6 months for every patient ]
    summary of the z-scores of all 15 paper and pencil cognitive tests


Secondary Outcome Measures:
  • specific cognitive domains- sum of z-scores of paper and pencil memory tests and of executive functions tests [ Time Frame: from the baseline until the end of the training duration of 6 months for every patient ]
    summary of z-scores of executive functions tests and of episodic memory tests

  • CogState [ Time Frame: from the baseline until the end of the training duration of 6 months for every patient ]
    Online cognitive test: the score is a summary of 4 sub-tests that include domains of attention, working memory and simple reaction time.


Other Outcome Measures:
  • hippocampal function [ Time Frame: from the baseline until the end of the training duration of 6 months for every patient ]
    using fMRI

  • prefrontal cortex function [ Time Frame: from the baseline until the end of the training duration of 6 months for every patient ]
    using fMRI


Estimated Enrollment: 200
Study Start Date: July 2016
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: training+VR+treadmill
This is the primary group of interest, where the investigators hypothesize the greatest cognitive gains will be found 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: training+VR
this group will be an active control receiving the VR cognitive training without treadmill walking, to examine whether the motor component of group 1 augments the effect of the VR.
Behavioral: cognitive training by virtual reality
Sham Comparator: TV program+treadmill
this group will watch a TV series on the brain 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 TV program while performing the same motor task as the VR group.
Behavioral: watching a tv series about the brain 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 subjects 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.

  Eligibility

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.


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.
  • Flucency in Hebrew, in order to understand the instructions of the cognitive tests.
  • Presence 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 going through a treatment which may interfere with the study program.
  Contacts and Locations
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
  More Information

Publications:

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02832921     History of Changes
Other Study ID Numbers: SHEBA-16-2988-MSB-CTIL
First Submitted: June 26, 2016
First Posted: July 14, 2016
Last Update Posted: July 17, 2017
Last Verified: July 2017
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