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Application of LLM Care and Related Affective Computing Systems on People With Parkinson's Disease (pdLLM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04426903
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Panos Bamidis, Aristotle University Of Thessaloniki

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: webFitForAll Other: BrainHQ Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to a group following different interventions
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Application of Cognitive and Physical Training (LLM Care) and Related Affective Computing Systems on People With Parkinson's Disease (Movement Disorders)
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LLM Care
LLM Care training Participants use the webFitForAll exergaming computer platform as the physical training component (PT); Participants use the language adapted version of the BrainHQ Program as the cognitive training component (CT)
Other: webFitForAll
PT training participants use the webFitForAll exergaming computer platform as the physical training component (PT)
Other Name: PT

Other: BrainHQ
CT training participants use the language adapted version of the BrainHQ program as the cognitive training component (CT)
Other Name: CT

Experimental: Physical Training (PT)
Physical training only. Participants use the webFitForAll exergaming computer platform as the physical training component (PT).
Other: webFitForAll
PT training participants use the webFitForAll exergaming computer platform as the physical training component (PT)
Other Name: PT

Experimental: Cognitive Training (CT)
Cognitive training only. Participants use the language adapted Version of the BrainHQ Program as the cognitive training component (CT).
Other: BrainHQ
CT training participants use the language adapted version of the BrainHQ program as the cognitive training component (CT)
Other Name: CT




Primary Outcome Measures :
  1. Physical capacity (general) [ Time Frame: 2 months ]
    Change in physical function as measured via the Short Physical Performance Battery (SPPB, scale from 0 to 12, perfect 12)

  2. Cognitive capacity (functional) [ Time Frame: 2 months ]
    MMSE: orientation, attention, memory, language and visual-spatial skills, scale: 0-30 perfect:30


Secondary Outcome Measures :
  1. Physical capacity (mobility) [ Time Frame: 2 months ]
    Change in functional mobility, gait and vestibular function as measured via the 10 Meter Walk test (timed score).

  2. Physical capacity (balance) [ Time Frame: 2 months ]
    Tinetti POMA: static and dynamic balance, scale: 0-28 perfect:28

  3. Body Weight index [ Time Frame: 2 months ]
    BMI

  4. Fitness [ Time Frame: 2 months ]
    Senior Fitness Test

  5. Physical capacity (balance & mobility) [ Time Frame: 2 months ]
    Community Balance & Mobility: balance and mobility, scale: 0-96 perfect:96

  6. Physical capacity (Functional mobility) [ Time Frame: 2 months ]
    Berg Balance Scale: functional mobility, scale: 0-56 perfect:56

  7. Cognitive capacity (Working memory) [ Time Frame: 2 months ]
    DIGIT Span: working memory

  8. Cognitive capacity (Selective attention) [ Time Frame: 2 months ]
    STROOP: selective attention, cognitive flexibility, and processing speed

  9. Cognitive capacity (Auditory-linguistic memory) [ Time Frame: 2 months ]
    LOGIC MEMORY: auditory-linguistic memory requiring verbal recall of auditorily presented story passages

  10. Quality of life index [ Time Frame: 2 months ]
    PDQ-8: activities of daily living, attention and working memory, communication, depression, quality of life, and social relationships in persons with Parkinson's Disease, scale: 0-100 (0: good health, 100: poor health)

  11. Social life [ Time Frame: 2 months ]
    FRIENDSHIP SCALE: social isolation, scale: 5-25 (0: good health, 100: poor health)

  12. Depression [ Time Frame: 2 months ]
    PHQ-9: depressive symptoms, scale: 0-27 (0: good health, 27: poor health)

  13. Changes in the cortical directed connectivity as measured via EEG [ Time Frame: 2 months ]
    Changes in the cortical connectivity caused via the training. Change is defined as statistical significance in the t-test comparison of the Phase Transfer Entropy (PTE) estimated from the cortical activity, as reconstructed via Low Resolution Electromagnetic Tomography (LORETA) algorithm on the basis of high-density EEG recordings, before compared to after the training.

  14. Changes in the graph theory indexes as measured via EEG [ Time Frame: 2 months ]
    Changes in the global and local graph theoretical indexes of the brain networks caused via the training. Change is defined as statistically significance in the t-test comparison of the graph theory indexes, before compared to after the training.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 50 years and older
  2. Natural speakers of the Greek language
  3. Possibility of commitment for the required intervention time
  4. No significant mobility problems (upper or lower limbs)
  5. Have good hearing and vision
  6. In case of any chronic diseases, such as hypertension, diabetes, etc., there should be advice from the competent doctor to keep the situation going under control
  7. There are no serious cardiovascular problems
  8. Assign a doctor for mild physical activity
  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, PD
  3. Substance abuse
  4. Use of Acetylcholinesterase inhibitor is not excluded, as long as the use has started 4 months before joining the study, and is stable during its course study remains constant
  5. Significant communication disorders
  6. Simultaneous enrollment in other studies
  7. Statin users may be excluded unless during the study the use is constant
  8. Patients diagnosed in stages 4 and 5 of the disease, or have undergone surgical treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04426903


Contacts
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Contact: Panagiotis D Bamidis, PhD +302310999310 bamidis@auth.gr

Locations
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Greece
Laboratory of Medical Physics, AUTH Recruiting
Thessaloniki, Greece
Contact: Panagiotis Bamidis, PhD    00302310999310    bamidis@med.auth.gr   
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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Principal Investigator: Panagiotis D bamidis, PhD Professor
Additional Information:
Publications:
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Responsible Party: Panos Bamidis, Professor, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT04426903    
Other Study ID Numbers: 490
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Panos Bamidis, Aristotle University Of Thessaloniki:
Physical Training
Cognitive Training
EEG
Neuroplasticity
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases