New Virtual Reality Technologies and Telemedicine for Cognitive Rehabilitation in Alzheimer's Disease (TaskCog-IVN)

January 20, 2023 updated by: Federica Alemanno, Ospedale San Raffaele

Harmonization and Application of Cognitive Rehabilitation Protocols Using New Technologies of Virtual Reality and Telemedicine, in Alzheimer's Disease

Main objective: To verify the effectiveness of a cognitive rehabilitation program in Alzheimer patients, based on virtual reality, delivered remotely, at the patient's home, with two distinct methods: a tablet or an App (on the patient's smartphone).

Total treatment duration: 2 months.

Main endpoint: Post rehabilitation assessment of the patient's cognitive level; Secondary endpoints: assessment of patients' quality of life quality of life and patients' and caregivers' satisfaction.

The neuropsychological assessment of the patients includes: Mini Mental State Examination (primary outcome), quality of life in Alzheimer's disease (QoL-AD), Geriatric Depression Scale (GDS). The following questionnaires will be submitted to caregivers: Beck Depression Inventory-II (BDI), System Usability Scale (SUS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Multicentric study involving the following 14 italian hospitals: San Raffaele Hospital of Milan, Fondazione Istituto Neurologico Carlo Besta, Istituto delle Scienze Neurologiche di Bologna, Fondazione Ca' Granda - Ospedale Maggiore Policlinico, Fondazione Don Carlo Gnocchi Onlus, Istituto Auxologico Italiano, Humanitas Mirasole, Istituti Clinici Scientifici Maugeri, Fondazione Istituto Neurologico Nazionale C. Mondino, Istituto Centro San Giovanni di Dio Fatebenefratelli, Fondazione Ospedale San Camillo, Fondazione Santa Lucia, Fondazione Policlinico Universitario Agostino Gemelli, Associazione Oasi Maria SS Onlus.

40 patients affected by Alzheimer's disease, with initial to severe cognitive impairment (MMSE 13-24), and 1 of their caregivers (total caregivers: N=40) will be included in the study (total n= 80 subjects).

The protocol provides for two treatment groups:

  • Tablet group (total number = 20 patients): cognitive rehabilitation carried out in telemedicine at home with tablets (using Khymeia VRRS Home Tablet equipment).
  • App group (total number = 20 patients): cognitive rehabilitation carried out in telemedicine at home with the App (Khymeia App Medico Amico).

Each AD patient, regardless of the severity of the cognitive impairment in progress, will be assigned to a treatment group. Allocation to the treatment group will be randomized by stratified randomization by severity of cognitive impairment (initial and moderate level, having MMSE between 24 and 18, vs., medium-severe level, having MMSE between 17 and 13).

Cognitive rehabilitation, for each group, will last two months. Patients will undergo 45 minutes of telehealth cognitive rehabilitation per day, 5 days a week, for a total duration of 2 months.

In both groups (Tablet or App), the rehabilitation exercises will be focused on the following cognitive functions:

  • Language
  • Attention
  • Executive functions
  • Verbal memory
  • Visuo-spatial memory

Evaluations will be carried out PRE and POST treatment, remotely (patient and caregiver at home, neuropsychologist in hospital).

PRE Ratings:

  • Within 7 days before the start of treatment;
  • Patient assessments: Mini Mental State Examination (primary outcome), quality of life in Alzheimer's disease (QoL-AD), Geriatric Depression Scale (GDS);
  • Caregiver assessments: Beck Depression Inventory-II (BDI).

POST Ratings:

  • Within 7 days after the last treatment session;
  • Patient assessments: Mini Mental State Examination (primary outcome), quality of life in Alzheimer's disease (QoL-AD), Geriatric Depression Scale (GDS);
  • Caregiver assessments: Beck Depression Inventory-II (BDI), System Usability Scale (SUS).

Total study duration per participant: 2.5 months.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Ospedale San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • inform consent
  • Proven diagnosis of Alzheimer's disease;
  • MMSE score between 13 and 24;
  • Aged between 50 and 80 years;
  • Stable drug therapy for at least 3 months.

Exclusion Criteria:

  • Denial of informed consent;
  • Psychiatric diseases;
  • Relevant cerebrovascular damage;
  • Disabling visual or hearing impairments;
  • Psychosis;
  • Major depression;
  • Abuse of alcohol or drugs;
  • Use of psychopharmacological agents that may interfere with test performance or treatment.
  • Participation in study protocols with experimental drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tablet group
The Tablet group will carry out the exercises using the Khymeia VRRS Home Tablet.
Procedure: Cognitive rehabilitation using interactive tablet
the cognitive rehabilitation exercises will be administered using the Khymeia VRRS Home Tablet. Patients will be asked to actively carry out exercises focused on the following cognitive functions: language, attention, executive functions, verbal memory, visuo-spatial memory.
Experimental: App group
The App group will perform the exercises on their smartphone using the Khymeia Medico Amico App.
Procedure: Cognitive rehabilitation using smartphone App Medico Amico
the cognitive rehabilitation exercises will be administered through patients' smartphone using the Medico Amico App. Patients will be asked to observe and concentrate on exercises focused on the following cognitive functions: language, attention, executive functions, verbal memory, visuo-spatial memory.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Mini Mental State Examination after treatment
Time Frame: After 2 months of treatment
Neuropsychological test for the evaluation of cognitive efficiency and the presence of cognitive impairment. The test consists of thirty items, which refer to seven different cognitive areas: orientation in time, orientation in space, memory, attention, and calculation, language, constructive ability. It ranges from 0 (poorest score) to 30 (normal cognition). An increase of the MMSE score indicate an improvement in general cognition.
After 2 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of life in Alzheimer's disease after treatment
Time Frame: After 2 months of treatment
The QOL-AD is a 13-item questionnaire designed to investigate, through the patient and caregiver, the quality of life (QOL) of patients diagnosed with Alzheimer's disease (AD). It ranges from 13 to 52. An increase in the scores indicate an improvement of the quality of life.
After 2 months of treatment
Change in Geriatric Depression Scale after treatment
Time Frame: After 2 months of treatment
Most widespread assessment scale for detecting depressive symptoms in frail elderly patients and in patients with dementia. It ranges from 0 (no depression) to 15 (probable depression). An increase in the GDS score indicates a worsening of the depression symptoms.
After 2 months of treatment
Change in Beck Depression Inventory-II after treatment
Time Frame: After 2 months of treatment
The BDI is a self-report tool consisting of 21 items. It assesses common symptoms of depression, and is considered a valid and reliable tool for screening for depression in the general population. It ranges from 0 (no depression) to 63 (major depression). Higher scores indicate an increase in depression severity.
After 2 months of treatment
System Usability Scale after treatment
Time Frame: After 2 months of treatment
The SUS is a Likert scale made up of ten elements which offers a global view of the subjective assessments of the usability of a system. Usability measurements consider several aspects: effectiveness (users can successfully achieve their goals), efficiency (how much effort and resources are spent to achieve those goals), and satisfaction (the experience was satisfactory). Scores range from 10 (poor satisfaction) to 100 (high satisfaction). High scores indicate a good satisfaction of the participant.
After 2 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale San Raffaele

Investigators

  • Principal Investigator: Federica Alemanno, Psy.D, Ph.D., Ospedale San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2021

Primary Completion (Actual)

December 21, 2021

Study Completion (Actual)

December 21, 2021

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Estimate)

January 25, 2023

Study Record Updates

Last Update Posted (Estimate)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TaskCog-IVN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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