Change in Executive Function and IADL Using a Virtual Supermarket Environment Among People With MCI

Mild Cognitive Impairment Clinical Trial

— EF-VAPS  

Official title:

Change in Executive Functions and in Instrumental Activities of Daily Living as a Result of Intervention by Virtual Supermarket Environment Among People With Mild Cognitive Impairment.

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01103453
• Other study ID #: CMC090105CTIL
• Status: Unknown status
• Phase: Phase 1
• First received: April 7, 2010
• Last updated: July 20, 2011
• Start date: November 2010
• Est. completion date: May 2012

Study information

• Verified date: July 2011
• Source: Carmel Medical Center
• Contact: Gary Sinoff, MD, PhD
• Phone: +972-4-8250552
• Email: GarySi[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to investigate the feasibility of using a virtual supermarket as an intervention tool for overcoming deficits in executive function as well as enhancing IADL performance among persons with Mild Cognitive Impairment. The working hypotheses are that there will be improvement in executive functions, and the improvement in the executive functions will result in better performance in Instrumental Activities of Daily Living, both generally and especially in shopping task

Description:

Scientific and clinical research in the area of Alzheimer's disease (AD) during the last years have shifted their focus to earlier diagnosis and especially to the transitional phase between normal aging and dementia, named Mild Cognitive Impairment (MCI).Lately, the concept of MCI has been expanded to address observed clinical heterogeneity, and subtypes were recognized: amnestic (including memory impairment) and non-amnestic (including impairment in other non-memory cognitive domains), with the later including deficits in executive functioning Executive functions (EF) are defined as higher order functions that are needed for completing complex or non-routine tasks. Deficits in EF refer to a collection of deficits in attention, planning, problem-solving, multitasking, monitoring and behavioral control and persons who suffer from impairments in EF typically have difficulty in initiating or suspending activities, show impaired mental flexibility, as well as increased distractibility and have difficulty in learning novel tasks despite apparently intact cognitive abilities.

Lately, an increasing amount of studies suggest that persons with MCI might have deficits in EF, moreover, persons presenting a combination of executive deficits and memory deficits were found to be a high risk group for conversion to AD.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 10
• Est. completion date: May 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age 60+

• Diagnosed as suffering from MCI

• No impaired judgement

• Verbal and written proficiency in Hebrew

• Normal or corrected-to-normal vision and hearing ability

• Independent in ADL function

• Lives in the community

• Able to perform task of shopping.

Exclusion Criteria:

• Suffering from other coexistent neurological diseases (e.g. stroke, muscular dystrophy)

• Has acute arthritis

• Poorly controlled hypothyroidism

• Suffering from physical or sensory limitations, as by self-report or noted by the investigator, that may limit the use of a computer's mouse

• No skills in performing shopping task

• Defined as suffering from depression as determined by the rating scale for depression

• Diagnosed as suffering from dementia as defined by Diagnostic and Statistical Manual of Mental Disorders criteria (DSM-IV)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Hypokinesia
• Lack of Physical Activity
• Mild Cognitive Impairment

Intervention

Behavioral:
• Virtual Action Planning Supermarket (VAP-S) Software
The VAP-S simulates a supermarket with multiple aisles displaying items. Several obstacles are designed to hinder the progression of the shopper along the aisles. In addition, virtual humans populate the supermarket. The VAP-S is designed so that the user enters the supermarket behind the cart and navigates within the supermarket via the keyboard keys. He is thus able to experience the environment personally without any intermediate. The task is to purchase 7 items from a list, proceed to the cashier and pay for them. We propose 9 sessions of 45 minutes. The results will be analyzed to develop goals for intervention, together with the client to study his awareness of his performance of IADL and Executive functions and to enhance his motivation to participate in the intervention.

Locations

Country	Name	City	State
Israel	Cognitive Clinic, Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (4)

Belleville S. Cognitive training for persons with mild cognitive impairment. Int Psychogeriatr. 2008 Feb;20(1):57-66. Epub 2007 Oct 25. Review. — View Citation

Josman N, Schenirderman AE, Klinger E, Shevil E. Using virtual reality to evaluate executive functioning among persons with schizophrenia: a validity study. Schizophr Res. 2009 Dec;115(2-3):270-7. doi: 10.1016/j.schres.2009.09.015. Epub 2009 Oct 22. — View Citation

Sgaramella TM, Borgo F, Mondini S, Pasini M, Toso V, Semenza C. Executive deficits appearing in the initial stage of Alzheimer's disease. Brain Cogn. 2001 Jun-Jul;46(1-2):264-8. — View Citation

Werner P, Rabinowitz S, Klinger E, Korczyn AD, Josman N. Use of the virtual action planning supermarket for the diagnosis of mild cognitive impairment: a preliminary study. Dement Geriatr Cogn Disord. 2009;27(4):301-9. doi: 10.1159/000204915. Epub 2009 Mar 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in executive functions by means of comparison to the results on the NexAde® computerized test.	The NexAde® is a computerized assessment test for deficits in cognition and executive function. The test consists of several neuropsychological tests used in clinical practice and research and the domains being assessed are attention, memory, visuomotor learning, spatial memory, executive function and mental flexibility. The test has been adapted for older adults who are not familiar with computers and was found to be reliable and valid.	1 month after intervention
Secondary	Improved performance in IADL, both generally and especially in shopping task.	IADL will be examined by means of results on the MET (Multiple Errands Test) and Lawton and Brody's IADL instruments. The MET assesses executive function while performing an everyday activity by observation. It consists of three main tasks in shopping: purchase six items, find out four different pieces of information and meet the examiner at a specific time at a predetermined location. Lawton & Brawdy's IADL instrument evaluates the subject's capacity to perform eight different IADL tasks such as cooking, the use of transportation and shopping.	1 month after intervention