Clinical trial NCT04390321: Application of LLM Care and Related Affective Computing Systems on Persons With Special Needs
Official title: Application of Cognitive and Physical Training (LLM Care) and Related Affective Computing Systems on Persons With Special Needs (Cognitive Disorders)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Keywords: Down Syndrome
Physical training
Cognitive training
EEG
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 46
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants are assigned to a single group following the same intervention
Primary purpose: OTHER

Brief summary: Down syndrome (DS) is a genetic disorder characterized by specific physical characteristics (muscle degeneration) and cognitive phenotype (neurodegeneration caused by gene-overexpression that has affected memory, language, and other executive functions). DS is the most prevalent reason for intellectual impairment but is also often accompanied by other medical conditions such as Alzheimer's disease. Given the increased cognitive decline inherent to DS, especially in the later years, the development of a non-invasive intervention protocol to counterbalance this prevalence is imperative.

This study is an adaptation of the Long Lasting Memories (LLM) (NCT02267499) and the subsequent LLM Care (NCT02313935) projects, specifically tailored to meet the needs and capacity of people with DS. The study aims to examine the effectiveness and any potential benefits of cognitive and physical training, as offered via the ICT-based (non-pharmacological) intervention of LLM Care, on people with DS. It is worth investigating whether this intervention can aid the development of independent living skills in DS individuals and the possibility of counterbalancing the degeneration, both physical and cognitive, caused by the expression of the extra genes. To evaluate any physical, cognitive, behavioral, and neuroplastic benefits/effects and measure the influence (affective status of participant) of the training, the study utilizes psycho-somatometric assessments and neuroscientific (electroencephalographic, EEG-related) indices, as well as affective computing systems.

Detailed description: Down Syndrome (DS) is a genetic disorder most commonly attributed to the trisomy of chromosome 21. It is considered the most prevalent reason for intellectual impairment. The extra chromosomic copy results in gene over-expression, which in turn is responsible for the characteristic non-uniform degeneration, affecting both cognition, and physical condition. The disorder has been linked to many underlying conditions such as early aging and Alzheimer's disease. Considering the cognitive decline that accompanies the increase in age, there is a need to develop non-invasive, counterbalancing interventions that will provide these individuals with a better quality of life and support them in acquiring and improving their skill set.

The target population is individuals with DS. The participants followed similar training schemes of the intervention, two days per week for one hour, for 10 weeks (aiming at 20 sessions/ participant), for one hour (30 minutes of cognitive and 30 minutes of physical training). Specifically, the participants completed the LLMcare protocol (combined cognitive and physical training) while a subgroup underwent measurements two times, one month apart, before initiating the intervention to serve as control.

The intervention is a based on 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/), and has been customized to meet the needs and capacity of people with DS. 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 main goal of this study is to quantify the effects of implementing the LLM Care intervention on people with DS, and particularly its effect on their physical status, cognition, behavior, and brain function. The study can potentially evaluate if adopting a cognitively and physically stimulating lifestyle can support DS individuals in acquiring and improving their skill set and act as and effective treatment against the physical and cognitive degeneration that is inherent to this syndrome The individuals with DS were evaluated via a battery of clinical and neuropsychological tests, and EEG measures at baseline (pre), exit (post) and one month after the training (follow up). 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:

* Down syndrome individuals

Exclusion Criteria:

* Ability to execute the physical training protocol
* Ability to execute the cognitive training protocol

Primary outcomes:
measure: Cognitive capacity (functional)
timeFrame: 2 months
measure: Physical capacity (general)
timeFrame: 2 months
Secondary outcomes:
measure: Cognitive capacity (verbal and non-verbal)
timeFrame: 2 months
measure: Cognitive capacity (emotion identification)
timeFrame: 2 months
measure: Physical capacity (mobility)
timeFrame: 2 months
measure: Physical capacity (flexibility)
timeFrame: 2 months
measure: Physical capacity (upper body strength)
timeFrame: 2 months
measure: Physical capacity (balance)
timeFrame: 2 months
measure: Physical capacity (stability)
timeFrame: 2 months
measure: Physical capacity (mobility and balance)
timeFrame: 2 months
measure: Change in current density strength of the cortical activity as measured via EEG
timeFrame: 2 months
measure: Change in cortical connectivity as measured via EEG
timeFrame: 2 months
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Laboratory of Medical Physics, AUTH
Study officials:
References:
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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.
citation: Anagnostopoulou A, Styliadis C, Kartsidis P, Romanopoulou E, Zilidou V, Karali C, Karagianni M, Klados M, Paraskevopoulos E, Bamidis PD. Computerized physical and cognitive training improves the functional architecture of the brain in adults with Down syndrome: A network science EEG study. Netw Neurosci. 2021 Mar 1;5(1):274-294. doi: 10.1162/netn_a_00177. eCollection 2021.