On-line Cognitive Training for Parkinson's Disease

Not Applicable

• Conditions: Parkinson Disease

• Registration Number: NCT04259827
• Lead Sponsor: Università degli Studi di Brescia

Brief 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.

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 Timeline

• Study Start: 2019-10-15
• Study First Submitted: 2020-01-18
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-05
• Last Update Submitted: 2020-02-05
• Study First Posted: 2020-02-07
• Last Update Posted: 2020-02-07
• Primary Completion: 2020-08-01
• Study Completion: 2021-02-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Trial making B performance, total score (0-240 seconds)	Changes between baseline, immediately after the end of intervention, after 1 month and 3 months	Trial making B performance, total score (0-240 seconds)
Parkinson´s disease Quality of life questionnire (PDQ-39) (0-117 points)	Changes between baseline, immediately after the end of intervention, after 1 month and 3 months	PDQ-39 will be assessed in patients
Supervised gait performance dual task gait	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
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	Sum of total Z-score of cognitive assessment (-30 to 30)
Supervised gait performance normal gait	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
Quality of life - caregivers	Changes between baseline, immediately after the end of intervention, after 1 month and 3 months	Caregiver Burden will be assessed with Dyadic relationship scale

Secondary Outcome Measures

Name	Time	Method
Unified parkinson´s disease Rating Scale part 3 (0-132 points)	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
Instability measures	Changes between baseline, immediately after the end of intervention, after 1 month and 3 months	Wearing sensors-based instability assessment (area of sway)
Turning performances	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
Dual task performance in circular walking (0-240 seconds)	Changes between baseline, immediately after the end of intervention, after 1 month and 3 months	Time performed in dual-task circular walking
Short Physical performance battery (SPPB), total time (0- 60 seconds)	Changes between baseline, immediately after the end of intervention, after 1 month and 3 months	Short Physical performance battery

Trial Locations

Locations (2)

Department of Neurology ASST Spedali Civili Brescia; 🇮🇹 Brescia, Lombardia, Italy

Parkinson's disease Rehabilitation Centre; 🇮🇹 Trescore Balneario, Lombardia, Italy