Lewy Body DiseaseLANG-LBDNCT05847985
Language and Lewy Body Diseases: Sentence Comprehension Problems and Modifying Noninvasive Brain Stimulation Treatment
A study testing transcranial direct current stimulation (tDCS) in people with Lewy Body Disease and Healthy Aging, run by Masaryk University at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lewy Body Disease, Healthy Aging
- What is being tested?
- transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Masaryk University CEITEC
Brno, 62500
Lubomira Novakova, +420549497766
About this study
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
- Being tested
- transcranial direct current stimulation (tDCS)
- Medical subject headings
- Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS)Device
tDCS using electric currents to modulate underlying neurons
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
sentence comprehension performance - accuracy
the investigators will study comprehension of syntactically complex sentences - accuracy in sentence comprehension task
Measured: 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
Measured: through study completion, an average of 1 year
Secondary outcomes (9)
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)
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - accuracy
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)
Measured: 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
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)
Measured: 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
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)
Measured: 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
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)
Measured: 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
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)
Measured: On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start1 May 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lewy Body DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847985
- Sponsor's protocol ID
- NU23J-04-00005
- Acronym
- LANG-LBD
- Status last verified
- Jan 2026
- First submitted
- 13 Apr 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Language and Lewy Body Diseases: Sentence Comprehension Problems and Modifying Noninvasive Brain Stimulation Treatment
- ClinicalTrials.gov ID
- NCT05847985
- Acronym / sponsor ID
- LANG-LBD / NU23J-04-00005
- Conditions
- Lewy Body Disease, Healthy Aging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: transcranial direct current stimulation (tDCS)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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- cardio pacemaker
- any MRI-incompatible metal in the body
- epilepsy
- any diagnosed psychiatric disorders
- alcohol/drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulation (tDCS)tDCS using electric currents to modulate underlying neurons | Device | Long-term effects of repeated sessions of home-based tDCS delivered via telepractice |
Primary outcome
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
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
9 secondary outcomes
relation of sentence comprehension performance to cognitive performance
Time frame: 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 neural underpinning of sentence comprehension deficits - resting state data
Time frame: 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
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 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 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 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 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) in people with Lewy Body Disease and Healthy Aging, run by Masaryk University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lubomira Novakova (+420 549 497 766, lubomira.novakova@ceitec.muni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sentence comprehension performance - accuracy (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.