Language and Lewy Body Diseases: Sentence Comprehension Problems and Modifying Noninvasive Brain Stimulation Treatment
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcranial direct current stimulation (tDCS).
- Who it may be relevant to
- Registry conditions: Lewy Body Disease, Healthy Aging. Basic parameters: 60 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device transcranial direct current stimulation (tDCS)
tDCS using electric currents to modulate underlying neurons
Primary outcome measures
- sentence comprehension performance - accuracy [Time frame: through study completion, an average of 1 year]
- sentence comprehension performance - reaction times [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (9)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Czechia · 1 center
- Masaryk University CEITEC — Brno
Identifiers
NCT: NCT05847985 · NU23J-04-00005