On-line Cognitive Training for Parkinson's Disease

NCT ID: NCT04259827

Last Updated: 2020-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2021-02-10

Brief Summary

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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.

Detailed Description

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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

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
The cognitive, motor and wearing sensors assessment will be performed by investigators blind to the treatment performed

Study Groups

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Online cognitive training

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

Group Type EXPERIMENTAL

Neuronation

Intervention Type OTHER

Online cognitive training app, with exercises created for patients with mild cognitive impairment

Aspecific online games

online application not created with a cognitive training purpose, for the same amount of time and frequence as the experimental group

Group Type ACTIVE_COMPARATOR

Aspecific online games

Intervention Type OTHER

Online gaming without cognitive training

No online cognitive training

normal clinical follow-up without cognitive training or gaming

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Neuronation

Online cognitive training app, with exercises created for patients with mild cognitive impairment

Intervention Type OTHER

Aspecific online games

Online gaming without cognitive training

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Brescia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Pilotto

Neurology Department Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessandro Padovani, Prof

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Brescia

Locations

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Department of Neurology ASST Spedali Civili Brescia

Brescia, Lombardy, Italy

Site Status RECRUITING

Parkinson's disease Rehabilitation Centre

Trescore Balneario, Lombardy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Andrea Pilotto, MD

Role: CONTACT

00393396245281

Sara Nocivelli, Psy

Role: CONTACT

Facility Contacts

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Andrea Pilotto, MD

Role: primary

00393396245281

Sara Nocivelli, MD

Role: backup

Andrea Pilotto, MD

Role: primary

00393396245281

Cristina Rizzetti, MD

Role: backup

Other Identifiers

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19/01

Identifier Type: -

Identifier Source: org_study_id

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