Language and Lewy Body Diseases: Sentence Comprehension Problems and Modifying Noninvasive Brain Stimulation Treatment (LANG-LBD)

May 25, 2023 updated by: Masaryk University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Brno, Czechia, 62500
        • Recruiting
        • Masaryk University CEITEC
        • Contact:
          • Lubomira Novakova
          • Phone Number: +420549497766

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Device: transcranial direct current stimulation (tDCS)
tDCS using electric currents to modulate underlying neurons

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year
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
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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)
On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment
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)
On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment
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)
On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment
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)
On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment
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)
On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masaryk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU23J-04-00005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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