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

NCT ID: NCT05847985

Last Updated: 2026-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Lewy Body Disease; Healthy Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Differences between LBDs patients and HC in regulation of language functions

In this study, 25 LBDs patients and 25 HC will undergo neuropsychological assessment, speech and writing recording, and MRI (structural T1 sequences, sentence comprehension fMRI task, neuromelanin-sensitive MRI sequence, and resting state measurement). The HC group will be matched to the LBDs patients with MCI for gender and age.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Long-term effects of repeated sessions of home-based tDCS delivered via telepractice

The investigators will use a parallel-group, double-blinded, randomized, sham-stimulation-controlled design. Forty LBDs patients will be randomized into two parallel groups, n = 20 subjects in each arm. For the active group, the investigators will use the stimulation protocol with the anode over the left IFG (cathode over the right supraorbital area, 2mA, 20 minutes). Participants will undergo a baseline assessment (A0, as described in arm 1); 10 stimulation sessions (in a two-week period); a follow-up assessment immediately after tDCS treatment (A1), and follow-up assessments 8 weeks (A2) after the baseline assessment. Each assessment will consist of a brief neuropsychological assessment, speech and writing recording and MRI scanning.

Group Type: EXPERIMENTAL

transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

tDCS using electric currents to modulate underlying neurons

Interventions

transcranial direct current stimulation (tDCS)

tDCS using electric currents to modulate underlying neurons

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Masaryk University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Masaryk University CEITEC

Brno, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Lubomira Novakova

Role: CONTACT

lubomira.novakova@ceitec.muni.cz

+420 549 497 766

Facility Contacts

Lubomira Novakova

Role: primary

+420549497766

Other Identifiers

NU23J-04-00005

Identifier Type: -

Identifier Source: org_study_id