NCT03486704

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

April 9, 2018

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 14, 2024

Status Verified

March 1, 2024

Enrollment Period

6.2 years

First QC Date

March 27, 2018

Last Update Submit

August 13, 2024

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Change in measure of quality of life

    Baseline up to 12 weeks and 4 and 7 months

  • Change in dementia severity

    Baseline up to 12 weeks and 4 and 7 months

  • Change in global cognition

    Baseline up to 12 weeks and 4 and 7 months

  • Change in memory complaints

    Baseline up to 12 weeks and 4 and 7 months

  • Change in visual constructional abilities

    Baseline up to 12 weeks and 4 and 7 months

  • +5 more secondary outcomes

Study Arms (5)

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.

Behavioral: Face to Face VRRS and telerehabilitation

Usual rehabilitation program

ACTIVE COMPARATOR

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

Behavioral: Usual rehabilitation 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.

Behavioral: FTF VRRS plus unstructured CS

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.

Behavioral: Face to Face VRRS plus active tDCS and telerehabilitation

Face to Face VRRS plus placebo tDCS and telerehabilitation

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.

Behavioral: Face to Face VRRS plus placebo tDCS and telerehabilitation

Interventions

Face to Face VRRS and telerehabilitationBEHAVIORAL

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).

Face to Face VRRS and telerehabilitation
Usual rehabilitation programBEHAVIORAL

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

Usual rehabilitation program
FTF VRRS plus unstructured CSBEHAVIORAL

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.

FTF VRRS plus unstructured CS
Face to Face VRRS plus active tDCS and telerehabilitationBEHAVIORAL

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 active tDCS and telerehabilitation
Face to Face VRRS plus placebo tDCS and telerehabilitationBEHAVIORAL

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).

Face to Face VRRS plus placebo tDCS and telerehabilitation

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Centro san Giovanni di Dio

Brescia, BS, 25125, Italy

Location

Related Publications (2)

  • 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.

    PMID: 38966802DERIVED

  • 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.

    PMID: 33304267DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 3, 2018

Study Start

April 9, 2018

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

August 14, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)