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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online cognitive training | Experimental | 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 |
|
| Aspecific online games | Active Comparator | online application not created with a cognitive training purpose, for the same amount of time and frequence as the experimental group |
|
| No online cognitive training | No Intervention | normal clinical follow-up without cognitive training or gaming |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuronation | Other | Online cognitive training app, with exercises created for patients with mild cognitive impairment |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Pilotto, MD | Contact | 00393396245281 | andrea.pilotto@unibs.it | |
| Sara Nocivelli, Psy | Contact | sara.nocivelli@unibs.it |
| Name | Affiliation | Role |
|---|---|---|
| Alessandro Padovani, Prof | Università degli Studi di Brescia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology ASST Spedali Civili Brescia | Recruiting | Brescia | Lombardy | 25123 | Italy |
Wearing sensors data will be available after completion of the trial.
After the completion of the trial
upon reasonable request
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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The cognitive, motor and wearing sensors assessment will be performed by investigators blind to the treatment performed
| Aspecific online games | Other | Online gaming without cognitive training |
|
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 |
| Parkinson's disease Rehabilitation Centre | Recruiting | Trescore Balneario | Lombardy | 25131 | Italy |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |