NCT04390321: dsLLM

Application of LLM Care and Related Affective Computing Systems on Persons With Special Needs

Completed NA Last updated 6 May 2023

What this trial tests

NA trial testing LLMcare in Down Syndrome in 46 participants. Completed in 1 January 2022.

Timeline

22 February 2017

Primary endpoint
1 January 2022

1 January 2022

Quick facts

Lead sponsor	Aristotle University Of Thessaloniki
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	46
Start date	22 February 2017
Primary completion	1 January 2022
Estimated completion	1 January 2022
Sites	1 location across Greece

Drugs / interventions tested

• LLMcare

Conditions studied

• Down Syndrome — all drugs for Down Syndrome →

Sponsor

Aristotle University Of Thessaloniki

Who can join

Adults 5 to 60, any sex, with Down Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Computerized physical and cognitive training improves the functional architecture of the brain in adults with Down syndrome: A network science EEG study.
   Anagnostopoulou A, Styliadis C, Kartsidis P, Romanopoulou E, et al · · 2021 · cited 6× · PMID 33688615 · DOI 10.1162/netn_a_00177
2. Computerized physical and cognitive training improves the functional architecture of the brain in adults with Down Syndrome: a network science EEG study
   Anagnostopoulou A, Styliadis C, Kartsidis P, Romanopoulou E, et al · · 2020 · DOI 10.1101/2020.05.28.20115709