Clinical trial NCT04426903: Application of LLM Care and Related Affective Computing Systems on People With Parkinson's Disease
Official title: Application of Cognitive and Physical Training (LLM Care) and Related Affective Computing Systems on People With Parkinson's Disease (Movement Disorders)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Physical Training
Cognitive Training
EEG
Neuroplasticity
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 23
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to a group following different interventions
Primary purpose: OTHER

Brief summary: The study is an adaptation of the Long Lasting Memories (LLM) (NCT02267499) and the subsequent LLM Care (NCT02313935) projects in patients with Parkinson's Disease (PD). The study aims to examine the viability and any potential benefits of cognitive and physical training, as offered via the ICT-based (non-pharmacological) intervention of LLM Care, on people with PD. It is worth investigating whether this intervention can offer a better quality of life in patients with PD and counterbalance the often associated with the PD disease neurodegeneration. To evaluate any physical, cognitive, behavioral, and neuroplastic changes and measure the influence (affective status of participant) of the training on the pathological population, the study utilizes somatometric and neuropsychological assessments and neuroscientific (electroencephalographic, EEG-related) indices, as well as affective computing systems.

Detailed description: Parkinson's Disease (PD) is a highly prevalent chronic neurodegenerative disease of the central nervous system, with both motor and non-motor symptoms, having a high impact on the quality of life of the patients. There is still no cure available for individuals with PD but only pharmaceutical treatments that manage the symptoms, thus non-pharmaceutical treatments such as physical and cognitive training are of great importance. This study aims to evaluate the benefits of the LLM Care (NCT02313935) Integrated Healthcare System (https://www.llmcare.gr/en/home/), which is a successful example of commercializing the LLM (NCT02267499) research program (http://www.longlastingmemories.eu/), in patients with PD. The LLM Care (non-pharmaceutical) intervention is an integrated training system that targets nondemented and demented aging population and adopts an approach of cognitive and physical training to improve the quality of life and prolong the functionality of the elders. The physical training (PT) component of the LLM, WebFitForAll, was developed by the research team of the Medical Physics Laboratory, Department of Medicine, Aristotle University of Thessaloniki. WebFitForAll is an effective physical platform that strengthens the body and enhances aerobic capacity, flexibility, and balance. The cognitive training (CT) component of the LLM is a Greek adaptation of the BrainHQ online interactive environment, and comprises six categories with 29 brain exercises with hundred levels of difficulty. The exercises focus on attention, memory, brain speed, people skills, navigation, and intelligence. The target population is PD patients which were classified according to their cognitive state as PD-cognitively normal (PD-CN) and PD-mild cognitive impairment (PD-MCI). Both PD-CN and PD-MCI followed similar training schemes of the intervention, two times per week for one hour for a total of 10 weeks (aiming at 20 sessions/individual). Specifically, the patients were categorized as follows: (i) LLM training group, where participants attended a training protocol consisting of pseudo-randomized physical and cognitive exercises (30 minutes of cognitive and 30 minutes of physical training), (ii) physical training group, whereas participants underwent only physical training (one hour of physical training), and (iii) cognitive training group, in which participants performed cognitive tasks (one hour of cognitive training). The main goal of this study is to quantify the effects of implementing the LLM Care intervention on patients with PD, determine any benefits in physical status, cognition, behavior, and brain function, and eventually assess if adopting a cognitively and physically stimulating lifestyle can offer a better quality of life in this pathological group. All of the patients were evaluated at baseline (pre) and exit (post) via EEG measures and a battery of routinely used clinical and neuropsychological tests. Additionally, the training platform utilizes affective computing systems to evaluate the affective status of all participants throughout the training and to establish a pleasant learning environment for all participants.

Eligibility criteria: Inclusion Criteria:

1. Age 50 years and older
2. Native level speakers of the Greek language
3. Able to commit for the required intervention time
4. No significant mobility problems (upper or lower limbs)
5. Normal or corrected to normal visual and auditory acuity
6. In case of any chronic diseases, such as hypertension, diabetes, etc., there should be advice from the competent doctor
7. No serious cardiovascular problems
8. Mild physical activity supervised by a physician
9. Stable medication so as not to affect the patient's functionality from Parkinson's motor symptoms (e.g., stiffness, dyskinesia, restlessness, gait disorder and instability, etc.)

Exclusion Criteria:

1. History of serious neurological diseases or psychiatric illness
2. Recent (within 6 months) history of stroke, transient ischemic stroke episode, traumatic brain injury, ALS, multiple sclerosis
3. Substance abuse
4. Use of acetylcholinesterase inhibitor is not excluded, as long as its use has started 4 months before joining the study, and is stable during its course study remains constant
5. Significant communication disorders
6. Simultaneous enrolment in other studies
7. Patients suspected of not being able or willing to cooperate or comply with study protocol requirements
8. Statin users may be excluded unless during the study the use is constant
9. Patients diagnosed in stages 4 and 5 of the disease, or have undergone surgical treatment

Primary outcomes:
measure: Change in current density strength of the cortical activity as measured via EEG.
timeFrame: 2 months
measure: Changes in the cortical directed connectivity as measured via EEG
timeFrame: 2 months
measure: Changes in the graph theory indexes as measured via EEG
timeFrame: 2 months
Secondary outcomes:
measure: Physical capacity (mobility)
timeFrame: 2 months
measure: Change in physical capacity (gait and balance, fall risk)
timeFrame: 2 months
measure: Body Weight index
timeFrame: 2 months
measure: Fitness
timeFrame: 2 months
measure: Physical capacity (balance & mobility)
timeFrame: 2 months
measure: Physical capacity (Functional mobility)
timeFrame: 2 months
measure: Quality of life index
timeFrame: 2 months
measure: Depression
timeFrame: 2 months
measure: Physical capacity (general)
timeFrame: 2 months
measure: Cognitive capacity (functional)
timeFrame: 2 months
measure: Cognitive capacity (Visuospatial attention)
timeFrame: 2 months
measure: Cognitive capacity
timeFrame: 2 months
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Laboratory of Medical Physics, AUTH
Study officials:
affiliation: Professor
name: Panagiotis D bamidis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Savvidis TP, Konstantinidis EI, Dias SB, Diniz JA, Hadjileontiadis LJ, Bamidis PD. Exergames for Parkinson's Disease Patients: How Participatory Design Led to Technology Adaptation. Stud Health Technol Inform. 2018;251:78-81.
citation: Konstantinidis EI, Bamparopoulos G, Bamidis PD. Moving Real Exergaming Engines on the Web: The webFitForAll Case Study in an Active and Healthy Ageing Living Lab Environment. IEEE J Biomed Health Inform. 2017 May;21(3):859-866. doi: 10.1109/JBHI.2016.2559787. Epub 2016 Apr 27.
citation: Styliadis C, Kartsidis P, Paraskevopoulos E, Ioannides AA, Bamidis PD. Neuroplastic effects of combined computerized physical and cognitive training in elderly individuals at risk for dementia: an eLORETA controlled study on resting states. Neural Plast. 2015;2015:172192. doi: 10.1155/2015/172192. Epub 2015 Apr 7.