Telerehabilitation in Mild Cognitive Impairment

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Behavioral: Face to Face VRRS and telerehabilitation; Behavioral: FTF VRRS plus unstructured CS; Behavioral: Usual rehabilitation program; Behavioral: Face to Face VRRS plus active tDCS and telerehabilitation; Behavioral: Face to Face VRRS plus placebo tDCS and telerehabilitation

• Registration Number: NCT03486704
• Lead Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-27
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-04-03
• Study Start: 2018-04-09
• Status Verified: 2024-03
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Face to Face VRRS and telerehabilitation	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.
FTF VRRS plus unstructured CS	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.
Usual rehabilitation program	Usual rehabilitation program	The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program.
Face to Face VRRS plus active tDCS and telerehabilitation	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 plus placebo tDCS and telerehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Change in long term episodic verbal memory	Baseline up to 12 weeks and 4 and 7 months	Auditory Verbal Learning Test, immediate and delayed recall

Secondary Outcome Measures

Name	Time	Method
Change in global cognition	Baseline up to 12 weeks and 4 and 7 months	Mini Mental State Examination (MMSE)
Change in nonverbal long term memory	Baseline up to 12 weeks and 4 and 7 months	Rey-Osterrieth Figure Recall
Change in visual attention and task switching	Baseline up to 12 weeks and 4 and 7 months	Trail Making Test
Change in naming abilities	Baseline up to 12 weeks and 4 and 7 months	Object and action naming subtests of the Battery for the Analysis of the Aphasic Deficit
Change in dementia severity	Baseline up to 12 weeks and 4 and 7 months	Clinical Dementia Rating scale (CDR)
Change in memory complaints	Baseline up to 12 weeks and 4 and 7 months	Everyday Memory Questionnaire (EMQ)
Change in non-verbal abstract reasoning	Baseline up to 12 weeks and 4 and 7 months	Raven's Colored Progressive Matrices
Change in verbal fluency	Baseline up to 12 weeks and 4 and 7 months	Phonemic verbal fluency and semantic verbal fluency
Change in measure of quality of life	Baseline up to 12 weeks and 4 and 7 months	Quality of Life in Alzheimer's Disease (AD) - QoL-AD
Change in visual constructional abilities	Baseline up to 12 weeks and 4 and 7 months	Rey-Osterrieth Figure Copy

Trial Locations

Locations (1)

IRCCS Centro san Giovanni di Dio; 🇮🇹 Brescia, BS, Italy