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Completed

NCT Number: NCT03486704

Telerehabilitation in Mild Cognitive Impairment

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Centro san Giovanni di Dio

Brescia, BS, 25125, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. 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)

  2. 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

  1. Change in measure of quality of life

    Time frame: Baseline up to 12 weeks and 4 and 7 months

    Quality of Life in Alzheimer's Disease (AD) - QoL-AD

  2. Change in dementia severity

    Time frame: Baseline up to 12 weeks and 4 and 7 months

    Clinical Dementia Rating scale (CDR)

  3. Change in global cognition

    Time frame: Baseline up to 12 weeks and 4 and 7 months

    Mini Mental State Examination (MMSE)

  4. Change in memory complaints

    Time frame: Baseline up to 12 weeks and 4 and 7 months

    Everyday Memory Questionnaire (EMQ)

  5. Change in visual constructional abilities

    Time frame: Baseline up to 12 weeks and 4 and 7 months

    Rey-Osterrieth Figure Copy

  6. Change in nonverbal long term memory

    Time frame: Baseline up to 12 weeks and 4 and 7 months

    Rey-Osterrieth Figure Recall

  7. Change in visual attention and task switching

    Time frame: Baseline up to 12 weeks and 4 and 7 months

    Trail Making Test

  8. Change in naming abilities

    Time frame: 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

  9. Change in non-verbal abstract reasoning

    Time frame: Baseline up to 12 weeks and 4 and 7 months

    Raven's Colored Progressive Matrices

  10. Change in verbal fluency

    Time frame: Baseline up to 12 weeks and 4 and 7 months

    Phonemic verbal fluency and semantic verbal fluency

Sponsors and collaborators

Lead sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Other

Collaborators

  • Fondazione Don Carlo Gnocchi ETS
  • IRCCS Centro Neurolesi Bonino Pulejo
  • IRCCS San Raffaele

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2018
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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