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| Name | Class |
|---|---|
| IRCCS Centro Neurolesi Bonino Pulejo | OTHER |
| Fondazione Don Carlo Gnocchi ETS | OTHER |
| IRCCS San Raffaele | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Face to Face VRRS and telerehabilitation | Experimental | 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. |
|
| Usual rehabilitation program | Active Comparator | The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program. |
|
| FTF VRRS plus unstructured CS | Active Comparator | 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. |
|
| Face to Face VRRS plus active tDCS and telerehabilitation | Experimental | 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 plus placebo tDCS and telerehabilitation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Face to Face VRRS and telerehabilitation | Behavioral | 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). |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Centro san Giovanni di Dio | Brescia | BS | 25125 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38966802 | Derived | Manenti R, Baglio F, Pagnoni I, Gobbi E, Campana E, Alaimo C, Rossetto F, Di Tella S, Pagliari C, Geviti A, Bonfiglio NS, Calabro RS, Cimino V, Binetti G, Quartarone A, Bramanti P, Cappa SF, Rossini PM, Cotelli M. Long-lasting improvements in episodic memory among subjects with mild cognitive impairment who received transcranial direct current stimulation combined with cognitive treatment and telerehabilitation: a multicentre, randomized, active-controlled study. Front Aging Neurosci. 2024 Jun 18;16:1414593. doi: 10.3389/fnagi.2024.1414593. eCollection 2024. | |
| 33304267 |
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| Active Comparator |
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. |
|
|
| Usual rehabilitation program | Behavioral | The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program. |
|
| FTF VRRS plus unstructured CS | Behavioral | 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. |
|
| Face to Face VRRS plus active tDCS and telerehabilitation | Behavioral | 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). |
|
| Face to Face VRRS plus placebo tDCS and telerehabilitation | Behavioral | 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). |
|
| 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 |
| Derived |
| Manenti R, Gobbi E, Baglio F, Macis A, Ferrari C, Pagnoni I, Rossetto F, Di Tella S, Alemanno F, Cimino V, Binetti G, Iannaccone S, Bramanti P, Cappa SF, Cotelli M. Effectiveness of an Innovative Cognitive Treatment and Telerehabilitation on Subjects With Mild Cognitive Impairment: A Multicenter, Randomized, Active-Controlled Study. Front Aging Neurosci. 2020 Nov 16;12:585988. doi: 10.3389/fnagi.2020.585988. eCollection 2020. |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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