Parkinson Disease
Conditions
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.
Interventions
OTHERNeuronation
Online cognitive training app, with exercises created for patients with mild cognitive impairment
OTHERAspecific online games
Online gaming without cognitive training
Sponsors
Università degli Studi di Brescia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The cognitive, motor and wearing sensors assessment will be performed by investigators blind to the treatment performed
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life - caregivers | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months | Caregiver Burden will be assessed with Dyadic relationship scale |
| Trial making B performance, total score (0-240 seconds) | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months | Trial making B performance, total score (0-240 seconds) |
| 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 | Sum of total Z-score of cognitive assessment (-30 to 30) |
| Supervised gait performance normal gait | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months | Step variability using wearing sensors technology in one-minute supervised walking |
| Supervised gait performance dual task gait | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months | Step variability using wearing sensors technology in one-minute supervised dual task walking |
| Parkinson´s disease Quality of life questionnire (PDQ-39) (0-117 points) | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months | PDQ-39 will be assessed in patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Instability measures | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months | Wearing sensors-based instability assessment (area of sway) |
| Turning performances | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months | Wearing sensors based turning speed in timed up and go test |
| Dual task performance in circular walking (0-240 seconds) | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months | Time performed in dual-task circular walking |
| Short Physical performance battery (SPPB), total time (0- 60 seconds) | Changes between baseline, immediately after the end of intervention, after 1 month and 3 months | Short Physical performance battery |
| Unified parkinson´s disease Rating Scale part 3 (0-132 points) | Changes between baseline, immediately after the end of intervention, after 1 month and 3 monthss | Total Movement Disorder Society-Unified Parkinson's disease Rating Scale part 3 motor score |
Countries
Italy
Contacts
Primary ContactAndrea Pilotto, MD
Backup ContactSara Nocivelli, Psy
Outcome results
None listed