On-line Cognitive Training for Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

On-line Cognitive Training for Mild Cognitive Impairment in Parkinson's Disease: a Randomized Single-blind Study Using Wearing Sensors Technology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04259827
• Other study ID #: 19/01
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: February 10, 2021

Study information

• Verified date: February 2020
• Source: Università degli Studi di Brescia
• Contact: Andrea Pilotto, MD
• Phone: 00393396245281
• Email: andrea.pilotto[@]unibs.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 10, 2021
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Neuronation
Online cognitive training app, with exercises created for patients with mild cognitive impairment
• Aspecific online games
Online gaming without cognitive training

Locations

Country	Name	City	State
Italy	Department of Neurology ASST Spedali Civili Brescia	Brescia	Lombardia
Italy	Parkinson's disease Rehabilitation Centre	Trescore Balneario	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Brescia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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