Clinical trial NCT04259827: On-line Cognitive Training for Parkinson's Disease
Official title: On-line Cognitive Training for Mild Cognitive Impairment in Parkinson's Disease: a Randomized Single-blind Study Using Wearing Sensors Technology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Trial making B performance, total score (0-240 seconds)
timeFrame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
measure: Sum of total Z-score of cognitive assessment (-30 to 30)
timeFrame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
measure: Supervised gait performance normal gait
timeFrame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
measure: Supervised gait performance dual task gait
timeFrame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
measure: Parkinson´s disease Quality of life questionnire (PDQ-39) (0-117 points)
timeFrame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
measure: Quality of life - caregivers
timeFrame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Secondary outcomes:
measure: Unified parkinson´s disease Rating Scale part 3 (0-132 points)
timeFrame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 monthss
measure: Instability measures
timeFrame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
measure: Turning performances
timeFrame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
measure: Dual task performance in circular walking (0-240 seconds)
timeFrame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
measure: Short Physical performance battery (SPPB), total time (0- 60 seconds)
timeFrame: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Department of Neurology ASST Spedali Civili Brescia
state: Lombardia
city: Trescore Balneario
country: Italy
facility: Parkinson's disease Rehabilitation Centre
state: Lombardia
Study officials:
affiliation: Università degli Studi di Brescia
name: Alessandro Padovani, Prof
role: PRINCIPAL_INVESTIGATOR
References: