---
title: Telerehabilitation in Mild Cognitive Impairment
nct_id: NCT03486704
overall_status: COMPLETED
phase: NA
sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
study_type: INTERVENTIONAL
primary_condition: Mild Cognitive Impairment
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03486704.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03486704"
ct_last_update_post_date: 2024-08-14
last_seen_at: "2026-05-12T06:41:11.384Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Telerehabilitation in Mild Cognitive Impairment

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

**NCT ID:** [NCT03486704](https://clinicaltrials.gov/study/NCT03486704)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 109
- **Lead Sponsor:** IRCCS Centro San Giovanni di Dio Fatebenefratelli
- **Collaborators:** IRCCS Centro Neurolesi Bonino Pulejo, Fondazione Don Carlo Gnocchi Onlus, IRCCS San Raffaele
- **Conditions:** Mild Cognitive Impairment
- **Start Date:** 2018-04-09
- **Completion Date:** 2024-06-30
- **CT.gov Last Update:** 2024-08-14

## 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.

## Eligibility

- **Minimum age:** 60 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **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.
```

## Arms

- **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** (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.

## Interventions

- **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).
- **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).

## Primary Outcomes

- **Change in long term episodic verbal memory** _(time frame: Baseline up to 12 weeks and 4 and 7 months)_ — Free and Cued Selective Reminding Test (FCSRT)
- **Change in long term episodic verbal memory** _(time frame: Baseline up to 12 weeks and 4 and 7 months)_ — Auditory Verbal Learning Test, immediate and delayed recall

## Secondary Outcomes

- **Change in measure of quality of life** _(time frame: Baseline up to 12 weeks and 4 and 7 months)_
- **Change in dementia severity** _(time frame: Baseline up to 12 weeks and 4 and 7 months)_
- **Change in global cognition** _(time frame: Baseline up to 12 weeks and 4 and 7 months)_
- **Change in memory complaints** _(time frame: Baseline up to 12 weeks and 4 and 7 months)_
- **Change in visual constructional abilities** _(time frame: Baseline up to 12 weeks and 4 and 7 months)_
- **Change in nonverbal long term memory** _(time frame: Baseline up to 12 weeks and 4 and 7 months)_
- **Change in visual attention and task switching** _(time frame: Baseline up to 12 weeks and 4 and 7 months)_
- **Change in naming abilities** _(time frame: Baseline up to 12 weeks and 4 and 7 months)_
- **Change in non-verbal abstract reasoning** _(time frame: Baseline up to 12 weeks and 4 and 7 months)_
- **Change in verbal fluency** _(time frame: Baseline up to 12 weeks and 4 and 7 months)_

## Locations (1)

- IRCCS Centro san Giovanni di Dio, Brescia, BS, Italy

## Recent Field Changes (last 30 days)

- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.irccs centro san giovanni di dio|brescia|bs|italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03486704.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03486704*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*