Telerehabilitation in Mild Cognitive Impairment

August 13, 2024 updated by: IRCCS Centro San Giovanni di Dio Fatebenefratelli

The Italian Network of Telerehabilitation: Evaluation of Telerehabilitation System in Mild Cognitive Impairment

The main aim of the study is to evaluate the efficacy of the Virtual Reality Rehabilitation System (VRRS) compared to usual care treatment for patients with Mild Cognitive Impairment (MCI). Moreover, we will assess the possibility to prolong the beneficial effects of the treatment with an innovative telerehabilitation system. In the second phase of the present study we aim to evaluate the short and long term effects induced by the treatment of active (anodal) transcranial Direct Current Stimulation (tDCS) applied to the left dorsolateral prefrontal cortex combined with VRRS compared to placebo tDCS stimulation combined with VRRS.

The effects of the intervention on outcome variables will be assessed using a randomized controlled trial design with five groups. The investigators will assess the effects of VRRS system and of the implementation of the at-home treatment on the quality of life, cognitive and functional abilities.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
109

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • BS
      • Brescia, BS, Italy, 25125
        • IRCCS Centro San Giovanni di Dio

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of MCI, defined according to standard criteria (Petersen et al., 2011)
  • Mini Mental State Examination (MMSE) ≥24
  • Education ≥ 5 years
  • All of the subjects will have normal or corrected-to-normal vision and will be native Italian speakers.
  • All participants reported subjective memory complaints and objective memory impairment, but no impairment of function in daily life.

Exclusion Criteria:

  • visual perception disorder and/or hearing loss
  • history of major psychiatric disorders
  • any contraindication for tDCS such as a history of seizures, major head trauma, past brain surgery, a brain metal implant or a pacemaker.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Face to Face VRRS and telerehabilitation
Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.
Behavioral: Face to Face VRRS and telerehabilitation

Face to Face cognitive training using VRRS plus telerehabilitation. Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.

Cognitive training will initially be tailored to the patient's baseline characteristics. The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.

The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program).
Active Comparator: Usual rehabilitation program
The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program.
Behavioral: Usual rehabilitation program
The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program.
Active Comparator: FTF VRRS plus unstructured CS
Participants will receive 12 sessions of an individualized Face to Face (FTF) cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based unstructured cognitive stimulation (CS), three sessions for week.
Behavioral: FTF VRRS plus unstructured CS

Face to Face cognitive training using VRRS plus at-home unstructured cognitive stimulation.

Participants will receive 12 sessions of an individualized Face to Face (FTF) cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based unstructured cognitive stimulation (CS), three sessions for week.
Experimental: Face to Face VRRS plus active tDCS and telerehabilitation
Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.
Behavioral: Face to Face VRRS plus active tDCS and telerehabilitation

Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.

Face to Face VRRS cognitive training will initially be tailored to the patient's baseline characteristics.

The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program).
Active Comparator: Face to Face VRRS plus placebo tDCS and telerehabilitation
Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with placebo tDCS applied to the dorsolateral prefrontal cortex of the left hemisphere over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.
Behavioral: Face to Face VRRS plus placebo tDCS and telerehabilitation

Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with placebo tDCS applied to the dorsolateral prefrontal cortex of the left hemisphere over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.

Face to Face VRRS cognitive training will initially be tailored to the patient's baseline characteristics.

The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in long term episodic verbal memory
Time Frame: Baseline up to 12 weeks and 4 and 7 months
Free and Cued Selective Reminding Test (FCSRT)
Baseline up to 12 weeks and 4 and 7 months
Change in long term episodic verbal memory
Time Frame: Baseline up to 12 weeks and 4 and 7 months
Auditory Verbal Learning Test, immediate and delayed recall
Baseline up to 12 weeks and 4 and 7 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in measure of quality of life
Time Frame: Baseline up to 12 weeks and 4 and 7 months
Quality of Life in Alzheimer's Disease (AD) - QoL-AD
Baseline up to 12 weeks and 4 and 7 months
Change in dementia severity
Time Frame: Baseline up to 12 weeks and 4 and 7 months
Clinical Dementia Rating scale (CDR)
Baseline up to 12 weeks and 4 and 7 months
Change in global cognition
Time Frame: Baseline up to 12 weeks and 4 and 7 months
Mini Mental State Examination (MMSE)
Baseline up to 12 weeks and 4 and 7 months
Change in memory complaints
Time Frame: Baseline up to 12 weeks and 4 and 7 months
Everyday Memory Questionnaire (EMQ)
Baseline up to 12 weeks and 4 and 7 months
Change in visual constructional abilities
Time Frame: Baseline up to 12 weeks and 4 and 7 months
Rey-Osterrieth Figure Copy
Baseline up to 12 weeks and 4 and 7 months
Change in nonverbal long term memory
Time Frame: Baseline up to 12 weeks and 4 and 7 months
Rey-Osterrieth Figure Recall
Baseline up to 12 weeks and 4 and 7 months
Change in visual attention and task switching
Time Frame: Baseline up to 12 weeks and 4 and 7 months
Trail Making Test
Baseline up to 12 weeks and 4 and 7 months
Change in naming abilities
Time Frame: Baseline up to 12 weeks and 4 and 7 months
Object and action naming subtests of the Battery for the Analysis of the Aphasic Deficit
Baseline up to 12 weeks and 4 and 7 months
Change in non-verbal abstract reasoning
Time Frame: Baseline up to 12 weeks and 4 and 7 months
Raven's Colored Progressive Matrices
Baseline up to 12 weeks and 4 and 7 months
Change in verbal fluency
Time Frame: Baseline up to 12 weeks and 4 and 7 months
Phonemic verbal fluency and semantic verbal fluency
Baseline up to 12 weeks and 4 and 7 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Centro San Giovanni di Dio Fatebenefratelli

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IRCCS San Raffaele
Fondazione Don Carlo Gnocchi Onlus
IRCCS Centro Neurolesi Bonino-Pulejo, Messina (IT)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VR-Rehab-MCI

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.

Clinical Trials on Mild Cognitive Impairment

Clinical Trials on Face to Face VRRS and telerehabilitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings