On-line Cognitive Training for Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Application of online cognitive training in patients affected by Parkinson's disease and mild cognitive impairment. The treatment consists of a 6-week on-line cognitive training preceded and followed by neurological, neuropsychological and motor assessment.

Detailed Description
-----------------
At the recruitment, participants will undergo a neurological visit, a neuropsychology assessment (2 tests for each considered cognitive domain: memory, attention, visuospatial, executive function, language) and a motor assessment with wearing sensors under supervised conditions. In the treatment arm only, patients will have the Neuronation application installed on their personal technology device (smartphone or tablet) and are asked to complete 4 training session three times a week. Each session is composed of 5 exercises from one out of 4 cognitive domains: Memory, Attention, Speed and Reasoning. The training is tailor made, the complexity of the exercises is adjusted online, based on the patient's performance. Participants are re-assessed at the end of the 6-week cognitive training (T1) to find out its effects on cognition and motor ability. The same assessment is administered also after 1 (T2) and 3 (T3) months from the end of the cognitive training to test long-term effects.

Official Title
-----------------
On-line Cognitive Training for Mild Cognitive Impairment in Parkinson's Disease: a Randomized Single-blind Study Using Wearing Sensors Technology

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Other: Neuronation
* Other: Aspecific online games


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ease of use of at home internet connection Active presence of a caregiver to help with the use of the App Sufficient physical ability to use a technological device Signature of informed consent Exclusion Criteria: Presence of systemic pathologies potentially responsible for cognitive deficits Presence of pathologies of the Central Nervous system potentially associated with cognitive deficits No access to internet connection Cognitive rehabilitation within the previous 6 months Major depression (assessed by Beck Depression Inventory at baseline)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a 3-arms single-blind parallel study. The patients are not blind to treatment , the investigators who will perform the baseline and follow-up assessment will be blinded to the treatment performed.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online cognitive training<br>6-week online personalized cognitive training using Neuronation platform 4 training session three times a week. Each session is composed of 5 exercises from one out of 4 cognitive domains: Memory, Attention, Speed and Reasoning | Other: Neuronation<br>* Online cognitive training app, with exercises created for patients with mild cognitive impairment<br>|
| Active Comparator: Aspecific online games<br>online application not created with a cognitive training purpose, for the same amount of time and frequence as the experimental group | Other: Aspecific online games<br>* Online gaming without cognitive training<br>|
| No Intervention: No online cognitive training<br>normal clinical follow-up without cognitive training or gaming | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trial making B performance, total score (0-240 seconds) | Trial making B performance, total score (0-240 seconds) | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months | 
| Sum of total Z-score of cognitive assessment (-30 to 30) | Sum of total Z-score of cognitive assessment (-30 to 30) | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months | 
| Supervised gait performance normal gait | Step variability using wearing sensors technology in one-minute supervised walking | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months | 
| Supervised gait performance dual task gait | Step variability using wearing sensors technology in one-minute supervised dual task walking | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months | 
| Parkinson´s disease Quality of life questionnire (PDQ-39) (0-117 points) | PDQ-39 will be assessed in patients | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months | 
| Quality of life - caregivers | Caregiver Burden will be assessed with Dyadic relationship scale | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified parkinson´s disease Rating Scale part 3 (0-132 points) | Total Movement Disorder Society-Unified Parkinson's disease Rating Scale part 3 motor score | Changes between baseline, immediately after the end of intervention, after 1 month and 3 monthss | 
| Instability measures | Wearing sensors-based instability assessment (area of sway) | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months | 
| Turning performances | Wearing sensors based turning speed in timed up and go test | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months | 
| Dual task performance in circular walking (0-240 seconds) | Time performed in dual-task circular walking | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months | 
| Short Physical performance battery (SPPB), total time (0- 60 seconds) | Short Physical performance battery | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months |