Telerehabilitation in Mild Cognitive Impairment

Study Overview
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Brief Summary
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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.

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

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Face to Face VRRS and telerehabilitation
* Behavioral: Usual rehabilitation program
* Behavioral: FTF VRRS plus unstructured CS
* Behavioral: Face to Face VRRS plus active tDCS and telerehabilitation
* Behavioral: Face to Face VRRS plus placebo tDCS and telerehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Face to Face VRRS and telerehabilitation<br>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<br>* 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).<br>|
| Active Comparator: Usual rehabilitation program<br>The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program. | Behavioral: Usual rehabilitation program<br>* The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program.<br>|
| Active Comparator: FTF VRRS plus unstructured CS<br>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<br>* 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.<br>|
| Experimental: Face to Face VRRS plus active tDCS and telerehabilitation<br>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<br>* 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).<br>|
| Active Comparator: Face to Face VRRS plus placebo tDCS and telerehabilitation<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in long term episodic verbal memory | Free and Cued Selective Reminding Test (FCSRT) | Baseline up to 12 weeks and 4 and 7 months | 
| Change in long term episodic verbal memory | Auditory Verbal Learning Test, immediate and delayed recall | Baseline up to 12 weeks and 4 and 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in measure of quality of life | Quality of Life in Alzheimer's Disease (AD) - QoL-AD | Baseline up to 12 weeks and 4 and 7 months | 
| Change in dementia severity | Clinical Dementia Rating scale (CDR) | Baseline up to 12 weeks and 4 and 7 months | 
| Change in global cognition | Mini Mental State Examination (MMSE) | Baseline up to 12 weeks and 4 and 7 months | 
| Change in memory complaints | Everyday Memory Questionnaire (EMQ) | Baseline up to 12 weeks and 4 and 7 months | 
| Change in visual constructional abilities | Rey-Osterrieth Figure Copy | Baseline up to 12 weeks and 4 and 7 months | 
| Change in nonverbal long term memory | Rey-Osterrieth Figure Recall | Baseline up to 12 weeks and 4 and 7 months | 
| Change in visual attention and task switching | Trail Making Test | Baseline up to 12 weeks and 4 and 7 months | 
| Change in naming abilities | 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 | Raven's Colored Progressive Matrices | Baseline up to 12 weeks and 4 and 7 months | 
| Change in verbal fluency | Phonemic verbal fluency and semantic verbal fluency | Baseline up to 12 weeks and 4 and 7 months |