Language and Lewy Body Diseases: Sentence Comprehension Problems and Modifying Noninvasive Brain Stimulation Treatment

Healthy Aging Clinical Trial

— LANG-LBD  

Official title:

Language and Lewy Body Diseases: Sentence Comprehension Problems and Modifying Noninvasive Brain Stimulation Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05847985
• Other study ID #: NU23J-04-00005
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2023
• Source: Masaryk University
• Contact: Lubomira Novakova
• Phone: +420 549 497 766
• Email: lubomira.novakova[@]ceitec.muni.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Lewy body diseases (LBDs) represents a group of neurodegenerative disorders characterized by the abnormal accumulation of aggregates of α-synuclein protein leading to the formation of Lewy bodies (LB) and Lewy neurites resulting in cell death. LBDs consists of two major clinical entities - Parkinson's disease (PD) and dementia with LB (DLB). Vast majority of patients with LBDs either already have mild cognitive impairment (MCI) at the time of the diagnosis or will develop it during the course of the disease. Language dysfunctions in LBDs patients with MCI are often unrecognized, which are difficult to treat, but even subtle changes might lead to impairment of social and occupational functioning with profound effect on their quality of lives. Current pharmacological or surgical strategies are effective for tackling the motor issues of LBDs with very limited effects on other symptoms such as language dysfunctions. Therefore, non-pharmacological approaches are gaining more attention. One of these non-pharmacological strategies is the use of noninvasive brain stimulation (NIBS) techniques that are able to modulate the brain functions with the effects on human nervous system plasticity. In this proposed project the investigators aim to first describe specific alterations in the language domain in LBDs patients with MCI as compared to healthy controls (HC) and identify the neural underpinnings of these changes using novel combination of advanced multimodal imaging techniques and various analytical methods. Secondly, the investigators aim to use NIBS as a supervised and individualized home-based therapeutical approach to tackle the language dysfunctions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• right-handedness

• Czech as their first language

• age (60-80 years)

• presence of PD-MCI (Litvan et al. 2012) or MCI-LB (McKeith et al. 2020) for LBD subjects

Exclusion Criteria:

• cardio pacemaker

• any MRI-incompatible metal in the body

• epilepsy

• any diagnosed psychiatric disorders

• alcohol/drug abuse

• for HC group the presence of LBDs or other neurodegenerative disorder or MCI/dementia

Related Conditions & MeSH terms

• Healthy Aging
• Lewy Body Disease

Intervention

Device:
• transcranial direct current stimulation (tDCS)
tDCS using electric currents to modulate underlying neurons

Locations

Country	Name	City	State
Czechia	Masaryk University CEITEC	Brno

Sponsors (1)

Lead Sponsor	Collaborator
Masaryk University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sentence comprehension performance - accuracy	the investigators will study comprehension of syntactically complex sentences - accuracy in sentence comprehension task	through study completion, an average of 1 year
Primary	sentence comprehension performance - reaction times	the investigators will study comprehension of syntactically complex sentences - reaction times in sentence comprehension task	through study completion, an average of 1 year
Secondary	relation of sentence comprehension performance to cognitive performance	the investigators will correlate sentence comprehension with cognitive functions: z-scores in following domains - memory, attention, executive function, visuospatial function and language function of Short Neuropsychological Battery (Bolcekova et al. 2020)	through study completion, an average of 1 year
Secondary	The neural underpinning of sentence comprehension deficits - sentence comprehension fMRI task data	The investigators will identify connectivity differences between HC and LBDs patients with MCI in language-related domain-specific and domain-general networks. In the task-based fMRI study, LBDs patients with MCI will show reduced activation and altered functional connectivity within and between these large-scale cortical networks compared to HC.	through study completion, an average of 1 year
Secondary	The neural underpinning of sentence comprehension deficits - resting state data	Abnormal intra- and inter-network dynamics will be apparent in resting-state fMRI of LBDs patients with MCI as compared to HC.	through study completion, an average of 1 year
Secondary	The neural underpinning of sentence comprehension deficits - structural MRI data	LBDs patients with MCI will show structural changes in language-related domain-specific and domain-general networks with neural degeneration as assessed by NMS-MRI as compared to HC.	through study completion, an average of 1 year
Secondary	the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - accuracy	the investigators will investigate the long-term effects of repeated sessions of home-based tDCS on sentence comprehension of syntactically complex sentences - accuracy in sentence comprehension task (as was described in outcome 1)	On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment
Secondary	the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - reaction times	the investigators will investigate the long-term effects of repeated sessions of home-based tDCS on sentence comprehension of syntactically complex sentences - reaction times in sentence comprehension task (as was described in outcome 2)	On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment
Secondary	the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - The neural underpinning of sentence comprehension deficits - resting state data	the investigators will investigate the long-term effects of repeated sessions of home-based tDCS on resting state data (as was described in outcome 5)	On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment
Secondary	the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - The neural underpinning of sentence comprehension deficits - sentence comprehension fMRI task data	the investigators will investigate the long-term effects of repeated sessions of home-based tDCS on sentence comprehension fMRI task data (as was described in outcome 4)	On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment
Secondary	the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - The neural underpinning of sentence comprehension deficits - structural MRI data	the investigators will investigate the long-term effects of repeated sessions of home-based tDCS on structural MRI data (as was described in outcome 6)	On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment