On-line Cognitive Training for Parkinson's Disease
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Oct 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2019
CompletedFirst Submitted
Initial submission to the registry
January 18, 2020
CompletedFirst Posted
Study publicly available on registry
February 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2021
CompletedFebruary 7, 2020
February 1, 2020
10 months
January 18, 2020
February 5, 2020
Conditions
Outcome Measures
Primary Outcomes (6)
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 Outcomes (5)
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
Instability measures
Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Turning performances
Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Dual task performance in circular walking (0-240 seconds)
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)
Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Study Arms (3)
Online cognitive training
EXPERIMENTAL6-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 COMPARATORonline 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 INTERVENTIONnormal clinical follow-up without cognitive training or gaming
Interventions
Online cognitive training app, with exercises created for patients with mild cognitive impairment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Neurology ASST Spedali Civili Brescia
Brescia, Lombardy, 25123, Italy
Parkinson's disease Rehabilitation Centre
Trescore Balneario, Lombardy, 25131, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alessandro Padovani, Prof
Università degli Studi di Brescia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- The cognitive, motor and wearing sensors assessment will be performed by investigators blind to the treatment performed
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neurology Department Director
Study Record Dates
First Submitted
January 18, 2020
First Posted
February 7, 2020
Study Start
October 15, 2019
Primary Completion
August 1, 2020
Study Completion
February 10, 2021
Last Updated
February 7, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- After the completion of the trial
- Access Criteria
- upon reasonable request
Wearing sensors data will be available after completion of the trial.