RecruitingNot ApplicableNCT05138588

Personalized Repetitive Transcranial Magnetic Stimulation (rTMS) in Cognitive Fluctuations of Dementia With Lewy Bodies (DLB): Proof of Concept


Sponsor

University Hospital, Strasbourg, France

Enrollment

40 participants

Start Date

Feb 2, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The present study is a monocentric, therapeutic clinical trial involving forty patients diagnosed with Dementia with Lewy Bodies (DLB). The aim of this clinical trial is to evaluate the feasibility and relevance of repetitive transcranial magnetic stimulation (rTMS); a non-invasive neuromodulation technique, with a main emphasis on the evaluation of the outcome on cognitive fluctuations. For this purpose, we will compare two distinct rTMS conditions (control and experimental) in a pre-post rTMS setting. The experimental condition will be targeting the insular cortex which has been shown to be affected at prodromal DLB stages, in the form of decreased grey matter concentration and a decreased regional Cerebral Blood Flow (rCBF hypoperfusion) \[Blanc et al., 2015 ; Roquet et al., 2016 ; Roquet et al., 2017\]. Furthermore, these insular alterations are correlated to cognitive fluctuations \[Chabran et al., 2020\]. In DLB, cognitive fluctuations are particularly pervasive and manifest in the form of alertness alterations and modifications of arousal states. Participants will repeatedly undergo a series of clinical and cognitive assessments in addition to several neuroimaging examinations, namely multimodal Magnetic Resonance Imaging (MRI) and electroencephalogram (EEG) recordings, in order to evaluate potential physiological modifications and clinical changes of symptoms, pre-/post-rTMS.


Eligibility

Min Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called rTMS for people with dementia with lewy bodies diagnosis and significant cognitive fluctuations in dlb. The study is currently recruiting participants at 1 location. People eligible for this study include aged 45 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICErTMS

For each subject, a verum condition and a control condition will be programmed. We will use the QPS-5 method (4 pulses, Inter-Stimulation Interval; ISI: 5 seconds).


Locations(1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

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NCT05138588