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NCT Number: NCT05847985

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

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.

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Key information

Conditions

Lewy Body Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Healthy Aging Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masaryk University CEITEC

Brno, 62500, Czechia

Location status: Recruiting

Location contact

Lubomira Novakova

CONTACT

+420549497766

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

tDCS using electric currents to modulate underlying neurons

Primary outcomes

  1. sentence comprehension performance - accuracy

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

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

  2. sentence comprehension performance - reaction times

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

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

Secondary outcomes

  1. relation of sentence comprehension performance to cognitive performance

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

    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)

  2. The neural underpinning of sentence comprehension deficits - sentence comprehension fMRI task data

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

    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.

  3. The neural underpinning of sentence comprehension deficits - resting state data

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

    Abnormal intra- and inter-network dynamics will be apparent in resting-state fMRI of LBDs patients with MCI as compared to HC.

  4. The neural underpinning of sentence comprehension deficits - structural MRI data

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

    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.

  5. the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - accuracy

    Time frame: On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment

    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)

  6. the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - reaction times

    Time frame: On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment

    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)

  7. the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - The neural underpinning of sentence comprehension deficits - resting state data

    Time frame: On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment

    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)

  8. 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

    Time frame: On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment

    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)

  9. the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - The neural underpinning of sentence comprehension deficits - structural MRI data

    Time frame: On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Lubomira Novakova

CONTACT

[email protected]

+420 549 497 766

Sponsors and collaborators

Lead sponsor

Masaryk University

Other

Registry information

Acronym: LANG-LBD

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 8, 2023
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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