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Telerehabilitation in Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Face to Face VRRS and telerehabilitation
Usual rehabilitation program
FTF VRRS plus unstructured CS
Face to Face VRRS plus active tDCS and telerehabilitation
Face to Face VRRS plus placebo tDCS and telerehabilitation
Sponsored by
IRCCS Centro San Giovanni di Dio Fatebenefratelli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • IRCCS Centro san Giovanni di DioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Active Comparator

Experimental

Active Comparator

Arm Label

Face to Face VRRS and telerehabilitation

Usual rehabilitation program

FTF VRRS plus unstructured CS

Face to Face VRRS plus active tDCS and telerehabilitation

Face to Face VRRS plus placebo tDCS and telerehabilitation

Arm 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.

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

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in long term episodic verbal memory
Free and Cued Selective Reminding Test (FCSRT)
Change in long term episodic verbal memory
Auditory Verbal Learning Test, immediate and delayed recall

Secondary Outcome Measures

Change in measure of quality of life
Quality of Life in Alzheimer's Disease (AD) - QoL-AD
Change in dementia severity
Clinical Dementia Rating scale (CDR)
Change in global cognition
Mini Mental State Examination (MMSE)
Change in memory complaints
Everyday Memory Questionnaire (EMQ)
Change in visual constructional abilities
Rey-Osterrieth Figure Copy
Change in nonverbal long term memory
Rey-Osterrieth Figure Recall
Change in visual attention and task switching
Trail Making Test
Change in naming abilities
Object and action naming subtests of the Battery for the Analysis of the Aphasic Deficit
Change in non-verbal abstract reasoning
Raven's Colored Progressive Matrices
Change in verbal fluency
Phonemic verbal fluency and semantic verbal fluency

Full Information

First Posted
March 27, 2018
Last Updated
September 27, 2023
Sponsor
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Collaborators
IRCCS Centro Neurolesi Bonino-Pulejo, Messina (IT), Fondazione Don Carlo Gnocchi Onlus, IRCCS San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT03486704
Brief Title
Telerehabilitation in Mild Cognitive Impairment
Official Title
The Italian Network of Telerehabilitation: Evaluation of Telerehabilitation System in Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Collaborators
IRCCS Centro Neurolesi Bonino-Pulejo, Messina (IT), Fondazione Don Carlo Gnocchi Onlus, IRCCS San Raffaele

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Face to Face VRRS and telerehabilitation
Arm Type
Experimental
Arm 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.
Arm Title
Usual rehabilitation program
Arm Type
Active Comparator
Arm Description
The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program.
Arm Title
FTF VRRS plus unstructured CS
Arm Type
Active Comparator
Arm 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.
Arm Title
Face to Face VRRS plus active tDCS and telerehabilitation
Arm Type
Experimental
Arm 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.
Arm Title
Face to Face VRRS plus placebo tDCS and telerehabilitation
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Face to Face VRRS and telerehabilitation
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Usual rehabilitation program
Intervention Description
The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program.
Intervention Type
Behavioral
Intervention Name(s)
FTF VRRS plus unstructured CS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Face to Face VRRS plus active tDCS and telerehabilitation
Intervention 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. 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).
Intervention Type
Behavioral
Intervention Name(s)
Face to Face VRRS plus placebo tDCS and telerehabilitation
Intervention 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. 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).
Primary Outcome Measure Information:
Title
Change in long term episodic verbal memory
Description
Free and Cued Selective Reminding Test (FCSRT)
Time Frame
Baseline up to 12 weeks and 4 and 7 months
Title
Change in long term episodic verbal memory
Description
Auditory Verbal Learning Test, immediate and delayed recall
Time Frame
Baseline up to 12 weeks and 4 and 7 months
Secondary Outcome Measure Information:
Title
Change in measure of quality of life
Description
Quality of Life in Alzheimer's Disease (AD) - QoL-AD
Time Frame
Baseline up to 12 weeks and 4 and 7 months
Title
Change in dementia severity
Description
Clinical Dementia Rating scale (CDR)
Time Frame
Baseline up to 12 weeks and 4 and 7 months
Title
Change in global cognition
Description
Mini Mental State Examination (MMSE)
Time Frame
Baseline up to 12 weeks and 4 and 7 months
Title
Change in memory complaints
Description
Everyday Memory Questionnaire (EMQ)
Time Frame
Baseline up to 12 weeks and 4 and 7 months
Title
Change in visual constructional abilities
Description
Rey-Osterrieth Figure Copy
Time Frame
Baseline up to 12 weeks and 4 and 7 months
Title
Change in nonverbal long term memory
Description
Rey-Osterrieth Figure Recall
Time Frame
Baseline up to 12 weeks and 4 and 7 months
Title
Change in visual attention and task switching
Description
Trail Making Test
Time Frame
Baseline up to 12 weeks and 4 and 7 months
Title
Change in naming abilities
Description
Object and action naming subtests of the Battery for the Analysis of the Aphasic Deficit
Time Frame
Baseline up to 12 weeks and 4 and 7 months
Title
Change in non-verbal abstract reasoning
Description
Raven's Colored Progressive Matrices
Time Frame
Baseline up to 12 weeks and 4 and 7 months
Title
Change in verbal fluency
Description
Phonemic verbal fluency and semantic verbal fluency
Time Frame
Baseline up to 12 weeks and 4 and 7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Cotelli, PhD
Phone
00390303501457
Email
mcotelli@fatebenefratelli.eu
Facility Information:
Facility Name
IRCCS Centro san Giovanni di Dio
City
Brescia
State/Province
BS
ZIP/Postal Code
25125
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Cotelli, PhD
Phone
00390303501457
Email
mcotelli@fatebenefratelli.eu
First Name & Middle Initial & Last Name & Degree
Stefano F Cappa, MD
Phone
00390303501327
Email
scappa@fatebenefratelli.eu
First Name & Middle Initial & Last Name & Degree
Rosa Manenti, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33304267
Citation
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.
Results Reference
derived

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Telerehabilitation in Mild Cognitive Impairment

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