On-line Cognitive Training for Parkinson's Disease

February 5, 2020 updated by: Andrea Pilotto, Università degli Studi di Brescia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
      • Trescore Balneario, Lombardia, Italy, 25131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: Neuronation
Online cognitive training app, with exercises created for patients with mild cognitive impairment
Active Comparator: Aspecific online games
online application not created with a cognitive training purpose, for the same amount of time and frequence as the experimental group
Other: Aspecific online games
Online gaming without cognitive training
No Intervention: No online cognitive training
normal clinical follow-up without cognitive training or gaming

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
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
Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
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
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)
Time Frame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
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
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
Changes between baseline, immediately after the end of intervention, after 1 month and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Total Movement Disorder Society-Unified Parkinson's disease Rating Scale part 3 motor score
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
Wearing sensors-based instability assessment (area of sway)
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
Wearing sensors based turning speed in timed up and go test
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
Time performed in dual-task circular walking
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
Short Physical performance battery
Changes between baseline, immediately after the end of intervention, after 1 month and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Brescia

Investigators

  • Principal Investigator: Alessandro Padovani, Prof, Università degli Studi di Brescia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2019

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

February 10, 2021

Study Registration Dates

First Submitted

January 18, 2020

First Submitted That Met QC Criteria

February 5, 2020

First Posted (Actual)

February 7, 2020

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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