Parkinson DiseaseNCT04259827
On-line Cognitive Training for Parkinson's Disease
A study testing Neuronation and Aspecific online games in people with Parkinson Disease, run by Università degli Studi di Brescia at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Neuronation and Aspecific online games
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesItaly
- Study dates
- 15 Oct 2019to 10 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Sara Nocivelli, Psy contact
Italy2 sites, 2 recruiting
- Recruiting
Department of Neurology ASST Spedali Civili Brescia
Brescia, Lombardy, 25123
Andrea Pilotto, MD, 00393396245281, andrea.pilotto@unibs.it
Sara Nocivelli, MD, sara.nocivelli@unibs.it
- Recruiting
Parkinson's disease Rehabilitation Centre
Trescore Balneario, Lombardy, 25131
Andrea Pilotto, MD, 00393396245281, pilottoandreae@gmail.com
Cristina Rizzetti, MD, rizzetti@ferbonlus.it
About this study
Official title: On-line Cognitive Training for Mild Cognitive Impairment in Parkinson's Disease: a Randomized Single-blind Study Using Wearing Sensors Technology
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Neuronation, Aspecific online games
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuronationOther
Online cognitive training app, with exercises created for patients with mild cognitive impairment
Aspecific online gamesOther
Online gaming without cognitive training
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Neuronation |
| 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 Receives: Other: Aspecific online games |
| No online cognitive training | No intervention | normal clinical follow-up without cognitive training or gaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial making B performance, total score (0-240 seconds)
Trial making B performance, total score (0-240 seconds)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Total Movement Disorder Society-Unified Parkinson's disease Rating Scale part 3 motor score
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start15 Oct 2019
- Primary completion1 Aug 2020 (estimated)
- Study completion10 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Pilotto, Università degli Studi di Brescia
- Investigators
- Alessandro Padovani, Prof, Principal investigator, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259827
- Sponsor's protocol ID
- 19/01
- Status last verified
- Feb 2020
- First submitted
- 18 Jan 2020
- Last updated
- 7 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Wearing sensors data will be available after completion of the trial.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-line Cognitive Training for Mild Cognitive Impairment in Parkinson's Disease: a Randomized Single-blind Study Using Wearing Sensors Technology
- ClinicalTrials.gov ID
- NCT04259827
- Acronym / sponsor ID
- 19/01
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 10 Feb 2021 (estimated)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Online cognitive training | Experimental | Other: Neuronation6-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 | Other: Aspecific online gamesonline 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 |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuronationOnline cognitive training app, with exercises created for patients with mild cognitive impairment | Other | Online cognitive training |
| Aspecific online gamesOnline gaming without cognitive training | Other | Aspecific online games |
Primary outcome
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
Trial making B performance, total score (0-240 seconds)
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
Sum of total Z-score of cognitive assessment (-30 to 30)
Supervised gait performance normal gait
Time frame: 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
Time frame: 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)
Time frame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
PDQ-39 will be assessed in patients
Quality of life - caregivers
Time frame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Caregiver Burden will be assessed with Dyadic relationship scale
5 secondary outcomes
Unified parkinson´s disease Rating Scale part 3 (0-132 points)
Time frame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 monthss
Instability measures
Time frame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Turning performances
Time frame: 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 frame: 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)
Time frame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: Yes. Wearing sensors data will be available after completion of the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Nocivelli, Psy contact
Alessandro Padovani, Prof principal investigator
Università degli Studi di Brescia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuronation and Aspecific online games in people with Parkinson Disease, run by Università degli Studi di Brescia at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Pilotto, MD (00393396245281, andrea.pilotto@unibs.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.