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

NCT ID: NCT01103453

Last Updated: 2011-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-05-31

Brief 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

Detailed 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.

Conditions

Mild Cognitive Impairment; Lack of Physical Activity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

Study group are persons diagnosed as suffering from Mild Cognitive Impairment will undergo a series of 9 sessions on a computer program of a virtual supermarket to improve their Executive and IADL functions.

Group Type: EXPERIMENTAL

Virtual Action Planning Supermarket (VAP-S) Software

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

VAP-S Virtual Action Planning - Supermarket; Virtools Development - Interactive 3D Development Tool; Discreet 3D Studio Max4 Graphics

Eligibility Criteria

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)

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carmel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Carmel Medical Center, Haifa, Israel

Principal Investigators

Gary Sinoff, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical center, Haifa, Israel

Locations

Cognitive Clinic, Carmel Medical Center

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Gary Sinoff, MD, PhD

Role: CONTACT

GarySi@clalit.org.il

+972-4-8250552

Facility Contacts

Gary Sinoff, MD, PhD

Role: primary

GarySi@clalit.org.il

+972-4-8250552

References

Belleville S. Cognitive training for persons with mild cognitive impairment. Int Psychogeriatr. 2008 Feb;20(1):57-66. doi: 10.1017/S104161020700631X. Epub 2007 Oct 25.

Reference Type: BACKGROUND

PMID: 17958927 (View on PubMed)

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. doi: 10.1016/s0278-2626(01)80080-4.

Reference Type: BACKGROUND

PMID: 11527345 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19850451 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19252401 (View on PubMed)

Other Identifiers

CMC090105CTIL

Identifier Type: -

Identifier Source: org_study_id