Clinical trial NCT05847985: Language and Lewy Body Diseases: Sentence Comprehension Problems and Modifying Noninvasive Brain Stimulation Treatment
Official title: Language and Lewy Body Diseases: Sentence Comprehension Problems and Modifying Noninvasive Brain Stimulation Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lewy Body Disease
Healthy Aging
Lead sponsor: Masaryk University
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: sentence comprehension performance - accuracy
timeFrame: through study completion, an average of 1 year
measure: sentence comprehension performance - reaction times
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: relation of sentence comprehension performance to cognitive performance
timeFrame: through study completion, an average of 1 year
measure: The neural underpinning of sentence comprehension deficits - sentence comprehension fMRI task data
timeFrame: through study completion, an average of 1 year
measure: The neural underpinning of sentence comprehension deficits - resting state data
timeFrame: through study completion, an average of 1 year
measure: The neural underpinning of sentence comprehension deficits - structural MRI data
timeFrame: through study completion, an average of 1 year
measure: the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - accuracy
timeFrame: On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment
measure: the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - reaction times
timeFrame: On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment
measure: the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - The neural underpinning of sentence comprehension deficits - resting state data
timeFrame: On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment
measure: 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
timeFrame: On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment
measure: the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - The neural underpinning of sentence comprehension deficits - structural MRI data
timeFrame: On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Masaryk University CEITEC
Study officials:
References: