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

Alzheimer's Disease (AD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02832921
• Other study ID #: SHEBA-16-2988-MSB-CTIL
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2016
• Last updated: January 24, 2018
• Start date: July 2016
• Est. completion date: August 2019

Study information

• Verified date: January 2018
• Source: Sheba Medical Center
• Contact: Glen M Doniger, PhD
• Email: Glen.Doniger[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease (AD)
• Dementia

Intervention

Behavioral:
• cognitive training by virtual reality

• 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".

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (19)

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Man DW, Chung JC, Lee GY. Evaluation of a virtual reality-based memory training programme for Hong Kong Chinese older adults with questionable dementia: a pilot study. Int J Geriatr Psychiatry. 2012 May;27(5):513-20. doi: 10.1002/gps.2746. Epub 2011 Jun 17. — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	specific cognitive domains- average of z-scores of paper and pencil memory tests and of executive functions tests	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)
Secondary	blood oxygenation level dependent (BOLD) functional MRI (fMRI) signal in the fronto-parietal network associated with working memory	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)
Secondary	brain resting state functional connectivity by resting state network fMRI BOLD signal correlations	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)
Secondary	hippocampal volume	3D T1-weighted MRI imaging	baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
Secondary	frontal inferior cortex volume	3D T1-weighted MRI imaging	baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
Secondary	white matter hyperintensity (WMH) burden	3D T2-FLAIR MRI imaging	baseline, immediately after 12-week training, and 3 months post-training (or corresponding time points in passive control group)
Secondary	diffusion-tensor imaging (DTI) measures	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)