Telerehabilitation in Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03486704
• Other study ID #: VR-Rehab-MCI
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: IRCCS Centro San Giovanni di Dio Fatebenefratelli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 109
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Centro san Giovanni di Dio	Brescia	BS

Sponsors (4)

Lead Sponsor	Collaborator
IRCCS Centro San Giovanni di Dio Fatebenefratelli	Fondazione Don Carlo Gnocchi Onlus, IRCCS Centro Neurolesi Bonino-Pulejo, Messina (IT), IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in long term episodic verbal memory	Free and Cued Selective Reminding Test (FCSRT)	Baseline up to 12 weeks and 4 and 7 months
Primary	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	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
Secondary	Change in dementia severity	Clinical Dementia Rating scale (CDR)	Baseline up to 12 weeks and 4 and 7 months
Secondary	Change in global cognition	Mini Mental State Examination (MMSE)	Baseline up to 12 weeks and 4 and 7 months
Secondary	Change in memory complaints	Everyday Memory Questionnaire (EMQ)	Baseline up to 12 weeks and 4 and 7 months
Secondary	Change in visual constructional abilities	Rey-Osterrieth Figure Copy	Baseline up to 12 weeks and 4 and 7 months
Secondary	Change in nonverbal long term memory	Rey-Osterrieth Figure Recall	Baseline up to 12 weeks and 4 and 7 months
Secondary	Change in visual attention and task switching	Trail Making Test	Baseline up to 12 weeks and 4 and 7 months
Secondary	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
Secondary	Change in non-verbal abstract reasoning	Raven's Colored Progressive Matrices	Baseline up to 12 weeks and 4 and 7 months
Secondary	Change in verbal fluency	Phonemic verbal fluency and semantic verbal fluency	Baseline up to 12 weeks and 4 and 7 months