Telerehabilitation in Mild Cognitive Impairment
- Conditions
- Mild Cognitive Impairment
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
- 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.
- 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
- 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 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 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 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
IRCCS Centro san Giovanni di Dio🇮🇹Brescia, BS, Italy