Clinical trial NCT03486704: Telerehabilitation in Mild Cognitive Impairment
Official title: The Italian Network of Telerehabilitation: Evaluation of Telerehabilitation System in Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
Sponsor class: OTHER
Collaborators: name: IRCCS Centro Neurolesi Bonino Pulejo
name: Fondazione Don Carlo Gnocchi Onlus
name: IRCCS San Raffaele
First posted: 2018-04-03
Enrollment: 109
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: 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.

Primary outcomes:
measure: Change in long term episodic verbal memory
timeFrame: Baseline up to 12 weeks and 4 and 7 months
measure: Change in long term episodic verbal memory
timeFrame: Baseline up to 12 weeks and 4 and 7 months
Secondary outcomes:
measure: Change in measure of quality of life
timeFrame: Baseline up to 12 weeks and 4 and 7 months
measure: Change in dementia severity
timeFrame: Baseline up to 12 weeks and 4 and 7 months
measure: Change in global cognition
timeFrame: Baseline up to 12 weeks and 4 and 7 months
measure: Change in memory complaints
timeFrame: Baseline up to 12 weeks and 4 and 7 months
measure: Change in visual constructional abilities
timeFrame: Baseline up to 12 weeks and 4 and 7 months
measure: Change in nonverbal long term memory
timeFrame: Baseline up to 12 weeks and 4 and 7 months
measure: Change in visual attention and task switching
timeFrame: Baseline up to 12 weeks and 4 and 7 months
measure: Change in naming abilities
timeFrame: Baseline up to 12 weeks and 4 and 7 months
measure: Change in non-verbal abstract reasoning
timeFrame: Baseline up to 12 weeks and 4 and 7 months
measure: Change in verbal fluency
timeFrame: Baseline up to 12 weeks and 4 and 7 months
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: IRCCS Centro san Giovanni di Dio
state: BS
Study officials:
References:
citation: 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.