Telerehabilitation in Mild Cognitive Impairment

Summary

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.

Conditions

• Mild Cognitive Impairment

Interventions

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).

BEHAVIORAL

Usual rehabilitation program

The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program.

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.

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).

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).

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo

  collaborator OTHER

• Fondazione Don Carlo Gnocchi Onlus

  collaborator OTHER

• IRCCS San Raffaele

  collaborator OTHER

• IRCCS Centro San Giovanni di Dio Fatebenefratelli

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-09

Primary Completion

2024-06-30

Completion

2024-06-30

Countries

• Italy

Study Locations