On-line Cognitive Training for Parkinson's Disease

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: Parkinson Disease
• Intervention / Treatment: Other: Neuronation; Other: Aspecific online games

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

Study Locations

• Italy
  • Lombardia
    • Brescia, Lombardia, Italy, 25123
      • Recruiting
      • Department of Neurology ASST Spedali Civili Brescia
      • Contact: Andrea Pilotto, MD; Phone Number: 00393396245281; Email: andrea.pilotto@unibs.it
      • Contact: Sara Nocivelli, MD; Email: sara.nocivelli@unibs.it
    • Trescore Balneario, Lombardia, Italy, 25131
      • Recruiting
      • Parkinson's disease Rehabilitation Centre
      • Contact: Andrea Pilotto, MD; Phone Number: 00393396245281; Email: pilottoandreae@gmail.com
      • Contact: Cristina Rizzetti, MD; Email: rizzetti@ferbonlus.it

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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)	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 Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• 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