Telerehabilitation in Mild Cognitive Impairment

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

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BS
    • Brescia, BS, Italy, 25125
      • IRCCS Centro San Giovanni di Dio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Face to Face VRRS and 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.	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).
Active Comparator: Usual rehabilitation program; The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program.	Behavioral: Usual rehabilitation program; The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program.
Active Comparator: FTF VRRS plus unstructured CS; 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; 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.
Experimental: 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.	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).
Active Comparator: 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.	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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
• Collaborators: IRCCS San Raffaele; Fondazione Don Carlo Gnocchi Onlus; IRCCS Centro Neurolesi Bonino-Pulejo, Messina (IT)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2018
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: VR-Rehab-MCI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No