Telerehabilitation in Mild Cognitive Impairment

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Face to Face VRRS plus active tDCS and telerehabilitation; Behavioral: Usual rehabilitation program; Behavioral: Face to Face VRRS and telerehabilitation; Behavioral: FTF VRRS plus unstructured CS; Behavioral: Face to Face VRRS plus placebo tDCS and telerehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03486704

VR-Rehab-MCI

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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109 participants in 5 patient groups

Face to Face VRRS and telerehabilitation

Experimental group

Description:

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.

Treatment:

Behavioral: Face to Face VRRS and telerehabilitation

Usual rehabilitation program

Active Comparator group

Description:

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

Treatment:

Behavioral: Usual rehabilitation program

FTF VRRS plus unstructured CS

Active Comparator group

Description:

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.

Treatment:

Behavioral: FTF VRRS plus unstructured CS

Face to Face VRRS plus active tDCS and telerehabilitation

Experimental group

Description:

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.

Treatment:

Behavioral: Face to Face VRRS plus active tDCS and telerehabilitation

Face to Face VRRS plus placebo tDCS and telerehabilitation

Active Comparator group

Description:

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.

Treatment:

Behavioral: Face to Face VRRS plus placebo tDCS and telerehabilitation