Cognitive-motor Intervention Using Virtual Reality for Middle-aged Individuals at High Dementia Risk
- Conditions
- Alzheimer's Disease (AD)
- Interventions
- Behavioral: cognitive training by virtual realityBehavioral: watching a scientific TV documentaryDevice: treadmill
- Registration Number
- NCT02832921
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VR cognitive tasks + treadmill cognitive training by virtual reality This is the primary group of interest, in which the investigators hypothesize the greatest cognitive gains since motor activity will augment cognitive activity. VR cognitive tasks - treadmill cognitive training by virtual reality 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. scientific TV documentary + treadmill 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. scientific TV documentary + treadmill watching a scientific TV documentary 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. VR cognitive tasks + treadmill treadmill This is the primary group of interest, in which the investigators hypothesize the greatest cognitive gains since motor activity will augment cognitive activity.
- Primary Outcome Measures
Name Time Method change in overall cognition- measured by averaging z-scores from 14 paper and pencil neuropsychological tests covering episodic memory and executive functions cognitive domains. 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
change in cerebral blood flow from arterial spin labeling (ASL) 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
Name Time Method hippocampal volume baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group) 3D T1-weighted MRI imaging
frontal inferior cortex volume baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group) 3D T1-weighted MRI imaging
white matter hyperintensity (WMH) burden baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group) 3D T2-FLAIR MRI imaging
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) summary of z-scores of executive functions tests and of episodic memory tests
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) 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
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) 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
diffusion-tensor imaging (DTI) measures 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
Trial Locations
- Locations (1)
Sheba Medical Center
🇮🇱Ramat Gan, Israel