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

NCT04426903 | Completed

• 1 other identifier: 490
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Physical Training; Cognitive Training; EEG; Neuroplasticity

Outcome Measures

Primary Outcomes (3)

• Change in current density strength of the cortical activity as measured via EEG.

  Change is defined as statistical significance in the t-test comparison of the current density strength as reconstructed via Low Resolution Electromagnetic Tomography (LORETA) algorithm on the basis of high-density EEG recordings before compared to after the training.

  2 months

• Changes in the cortical directed connectivity as measured via EEG

  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.

  2 months

• Changes in the graph theory indexes as measured via EEG

  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.

  2 months

Secondary Outcomes (12)

• Physical capacity (mobility)

  2 months

• Change in physical capacity (gait and balance, fall risk)

  2 months

• Body Weight index

  2 months

• Fitness

  2 months

• Physical capacity (balance & mobility)

  2 months

Study Arms (3)

LLM Care

EXPERIMENTAL

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; Other: BrainHQ

Physical Training (PT)

EXPERIMENTAL

Physical training only. Participants use the webFitForAll exergaming computer platform as the physical training component (PT).

Other: webFitForAll

Cognitive Training (CT)

EXPERIMENTAL

Cognitive training only. Participants use the language adapted Version of the BrainHQ Program as the cognitive training component (CT).

Other: BrainHQ

Interventions

webFitForAll OTHER

PT training participants use the webFitForAll exergaming computer platform as the physical training component (PT)

Also known as: PT

LLM Care; Physical Training (PT)

BrainHQ OTHER

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

Also known as: CT

Cognitive Training (CT); LLM Care

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 years and older
• Native level speakers of the Greek language
• Able to commit for the required intervention time
• No significant mobility problems (upper or lower limbs)
• Normal or corrected to normal visual and auditory acuity
• In case of any chronic diseases, such as hypertension, diabetes, etc., there should be advice from the competent doctor
• No serious cardiovascular problems
• Mild physical activity supervised by a physician
• 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.)

You may not qualify if:

• History of serious neurological diseases or psychiatric illness
• Recent (within 6 months) history of stroke, transient ischemic stroke episode, traumatic brain injury, ALS, multiple sclerosis
• Substance abuse
• 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
• Significant communication disorders
• Simultaneous enrolment in other studies
• Patients suspected of not being able or willing to cooperate or comply with study protocol requirements
• Statin users may be excluded unless during the study the use is constant
• Patients diagnosed in stages 4 and 5 of the disease, or have undergone surgical treatment

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Laboratory of Medical Physics, AUTH

Thessaloniki, Greece

Location

Related Publications (3)

• 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.

  PMID: 29968606 BACKGROUND

• 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.

  PMID: 28113566 BACKGROUND

• 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.

  PMID: 25945260 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Panagiotis D bamidis, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are assigned to a group following different interventions

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: March 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)