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

NCT05847985 | Recruiting

• 1 other identifier: NU23J-04-00005
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (9)

• relation of sentence comprehension performance to cognitive performance

  through study completion, an average of 1 year

• The neural underpinning of sentence comprehension deficits - sentence comprehension fMRI task data

  through study completion, an average of 1 year

• The neural underpinning of sentence comprehension deficits - resting state data

  through study completion, an average of 1 year

• The neural underpinning of sentence comprehension deficits - structural MRI data

  through study completion, an average of 1 year

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

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

Study Arms (2)

Differences between LBDs patients and HC in regulation of language functions

NO INTERVENTION

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.

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

EXPERIMENTAL

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.

Device: transcranial direct current stimulation (tDCS)

Interventions

transcranial direct current stimulation (tDCS) DEVICE

tDCS using electric currents to modulate underlying neurons

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

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masaryk University: lead

Study Sites (1)

Masaryk University CEITEC

Brno, 62500, Czechia

RECRUITING

MeSH Terms

Conditions

Lewy Body Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Lubomira Novakova

CONTACT

+420 549 497 766; lubomira.novakova@ceitec.muni.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 8, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Locations

CZ (1)