NCT05847985 Language and Lewy Body Diseases: Sentence Comprehension Problems and Modifying Noninvasive Brain Stimulation Treatment
| NCT ID | NCT05847985 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Masaryk University |
| Condition | Lewy Body Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2023-05-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05847985 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 80 Years, studying Lewy Body Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05847985 currently recruiting?
Yes, NCT05847985 is actively recruiting participants. Contact the research team at lubomira.novakova@ceitec.muni.cz for enrollment information.
Where is the NCT05847985 trial being conducted?
This trial is being conducted at Brno, Czechia.
Who is sponsoring the NCT05847985 clinical trial?
NCT05847985 is sponsored by Masaryk University. The trial plans to enroll 90 participants.