On-line Cognitive Training for Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Neuronation
Aspecific online games
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
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)
Sites / Locations
- Department of Neurology ASST Spedali Civili BresciaRecruiting
- Parkinson's disease Rehabilitation CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Online cognitive training
Aspecific online games
No online cognitive training
Arm Description
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
online application not created with a cognitive training purpose, for the same amount of time and frequence as the experimental group
normal clinical follow-up without cognitive training or gaming
Outcomes
Primary Outcome Measures
Trial making B performance, total score (0-240 seconds)
Trial making B performance, total score (0-240 seconds)
Sum of total Z-score of cognitive assessment (-30 to 30)
Sum of total Z-score of cognitive assessment (-30 to 30)
Supervised gait performance normal gait
Step variability using wearing sensors technology in one-minute supervised walking
Supervised gait performance dual task gait
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)
PDQ-39 will be assessed in patients
Quality of life - caregivers
Caregiver Burden will be assessed with Dyadic relationship scale
Secondary Outcome Measures
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
Instability measures
Wearing sensors-based instability assessment (area of sway)
Turning performances
Wearing sensors based turning speed in timed up and go test
Dual task performance in circular walking (0-240 seconds)
Time performed in dual-task circular walking
Short Physical performance battery (SPPB), total time (0- 60 seconds)
Short Physical performance battery
Full Information
NCT ID
NCT04259827
First Posted
January 18, 2020
Last Updated
February 5, 2020
Sponsor
Università degli Studi di Brescia
1. Study Identification
Unique Protocol Identification Number
NCT04259827
Brief Title
On-line Cognitive Training for Parkinson's Disease
Official Title
On-line Cognitive Training for Mild Cognitive Impairment in Parkinson's Disease: a Randomized Single-blind Study Using Wearing Sensors Technology
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
February 10, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Brescia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
The cognitive, motor and wearing sensors assessment will be performed by investigators blind to the treatment performed
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Online cognitive training
Arm Type
Experimental
Arm Description
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
Arm Title
Aspecific online games
Arm Type
Active Comparator
Arm Description
online application not created with a cognitive training purpose, for the same amount of time and frequence as the experimental group
Arm Title
No online cognitive training
Arm Type
No Intervention
Arm Description
normal clinical follow-up without cognitive training or gaming
Intervention Type
Other
Intervention Name(s)
Neuronation
Intervention Description
Online cognitive training app, with exercises created for patients with mild cognitive impairment
Intervention Type
Other
Intervention Name(s)
Aspecific online games
Intervention Description
Online gaming without cognitive training
Primary Outcome Measure Information:
Title
Trial making B performance, total score (0-240 seconds)
Description
Trial making B performance, total score (0-240 seconds)
Time Frame
Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Title
Sum of total Z-score of cognitive assessment (-30 to 30)
Description
Sum of total Z-score of cognitive assessment (-30 to 30)
Time Frame
Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Title
Supervised gait performance normal gait
Description
Step variability using wearing sensors technology in one-minute supervised walking
Time Frame
Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Title
Supervised gait performance dual task gait
Description
Step variability using wearing sensors technology in one-minute supervised dual task walking
Time Frame
Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Title
Parkinson´s disease Quality of life questionnire (PDQ-39) (0-117 points)
Description
PDQ-39 will be assessed in patients
Time Frame
Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Title
Quality of life - caregivers
Description
Caregiver Burden will be assessed with Dyadic relationship scale
Time Frame
Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Secondary Outcome Measure Information:
Title
Unified parkinson´s disease Rating Scale part 3 (0-132 points)
Description
Total Movement Disorder Society-Unified Parkinson's disease Rating Scale part 3 motor score
Time Frame
Changes between baseline, immediately after the end of intervention, after 1 month and 3 monthss
Title
Instability measures
Description
Wearing sensors-based instability assessment (area of sway)
Time Frame
Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Title
Turning performances
Description
Wearing sensors based turning speed in timed up and go test
Time Frame
Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Title
Dual task performance in circular walking (0-240 seconds)
Description
Time performed in dual-task circular walking
Time Frame
Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Title
Short Physical performance battery (SPPB), total time (0- 60 seconds)
Description
Short Physical performance battery
Time Frame
Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Pilotto, MD
Phone
00393396245281
Email
andrea.pilotto@unibs.it
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Nocivelli, Psy
Email
sara.nocivelli@unibs.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Padovani, Prof
Organizational Affiliation
Università degli Studi di Brescia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology ASST Spedali Civili Brescia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Pilotto, MD
Phone
00393396245281
Email
andrea.pilotto@unibs.it
First Name & Middle Initial & Last Name & Degree
Sara Nocivelli, MD
Email
sara.nocivelli@unibs.it
Facility Name
Parkinson's disease Rehabilitation Centre
City
Trescore Balneario
State/Province
Lombardia
ZIP/Postal Code
25131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Pilotto, MD
Phone
00393396245281
Email
pilottoandreae@gmail.com
First Name & Middle Initial & Last Name & Degree
Cristina Rizzetti, MD
Email
rizzetti@ferbonlus.it
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Wearing sensors data will be available after completion of the trial.
IPD Sharing Time Frame
After the completion of the trial
IPD Sharing Access Criteria
upon reasonable request
Learn more about this trial
On-line Cognitive Training for Parkinson's Disease
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