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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorMasaryk University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

cardio pacemaker

any MRI-incompatible metal in the body

epilepsy

any diagnosed psychiatric disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • transcranial direct current stimulation (tDCS)

    Device

    tDCS using electric currents to modulate underlying neurons

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Differences between LBDs patients and HC in regulation of language functionsNo intervention 0 interventions
Group B: Long-term effects of repeated sessions of home-based tDCS delivered via telepracticeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

sentence comprehension performance - accuracy

the investigators will study comprehension of syntactically complex sentences - accuracy in sentence comprehension task

Time frame
through study completion, an average of 1 year
2

sentence comprehension performance - reaction times

the investigators will study comprehension of syntactically complex sentences - reaction times in sentence comprehension task

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

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)

Time frame
through study completion, an average of 1 year
2

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.

Time frame
through study completion, an average of 1 year
3

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.

Time frame
through study completion, an average of 1 year
4

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.

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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