Mild Cognitive Impairment
Conditions
Brief 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.
Interventions
BEHAVIORALFace 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).
BEHAVIORALUsual rehabilitation program
The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program.
BEHAVIORALFTF 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.
BEHAVIORALFace 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).
BEHAVIORALFace 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
IRCCS Centro Neurolesi Bonino Pulejo
Fondazione Don Carlo Gnocchi Onlus
IRCCS San Raffaele
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in long term episodic verbal memory | Baseline up to 12 weeks and 4 and 7 months | Free and Cued Selective Reminding Test (FCSRT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in dementia severity | Baseline up to 12 weeks and 4 and 7 months | Clinical Dementia Rating scale (CDR) |
| Change in global cognition | Baseline up to 12 weeks and 4 and 7 months | Mini Mental State Examination (MMSE) |
| Change in memory complaints | Baseline up to 12 weeks and 4 and 7 months | Everyday Memory Questionnaire (EMQ) |
| Change in visual constructional abilities | Baseline up to 12 weeks and 4 and 7 months | Rey-Osterrieth Figure Copy |
| Change in measure of quality of life | Baseline up to 12 weeks and 4 and 7 months | Quality of Life in Alzheimer's Disease (AD) - QoL-AD |
| Change in visual attention and task switching | Baseline up to 12 weeks and 4 and 7 months | Trail Making Test |
| Change in naming abilities | 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 |
| Change in non-verbal abstract reasoning | Baseline up to 12 weeks and 4 and 7 months | Raven's Colored Progressive Matrices |
| Change in verbal fluency | Baseline up to 12 weeks and 4 and 7 months | Phonemic verbal fluency and semantic verbal fluency |
| Change in nonverbal long term memory | Baseline up to 12 weeks and 4 and 7 months | Rey-Osterrieth Figure Recall |
Countries
Italy
Outcome results
None listed