Actively Recruiting
Personalized Repetitive Transcranial Magnetic Stimulation (rTMS) in Cognitive Fluctuations of Dementia With Lewy Bodies (DLB): Proof of Concept
Led by University Hospital, Strasbourg, France · Updated on 2025-08-08
40
Participants Needed
1
Research Sites
334 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Personalized Repetitive Transcranial Magnetic Stimulation (rTMS) in Cognitive Fluctuations of Dementia With Lewy Bodies (DLB): Proof of Concept
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patient aged 65 45 years
- Enrolled in a social health insurance scheme
- Diagnosed with probable Dementia with Lewy Bodies (DLB) according to McKeith et al. criteria, 2017 or 2020
- Mini Mental State Examination (MMSE) score 65 18 in the last 6 months
- MMSE score 65 15 at the inclusion visit
- Presence of clinically significant cognitive fluctuations
- Caregivers able to stay with the patient for at least 4 hours a day, 3 days a week and provide requested information
- Patient able to understand the study objectives and risks and provide signed informed consent
- Women of childbearing age must use effective contraception throughout the study
You will not qualify if you...
- History of generalized seizures (epilepsy)
- Recent dose changes (within 2 months) in medications for cognitive fluctuations in DLB (anticholinesterase and neuroleptics)
- Treatment with the anti-epileptic drug Levetiracetam (Keppra)
- History of psychosis or severe depression unrelated to DLB
- History of brain surgery including tumor removal or electrode implantation
- Contraindications for MRI such as claustrophobia or implanted electronic devices
- Inability to understand the study or provide informed consent
- MMSE score below 18 in the last 6 months
- MMSE score below 15 at inclusion
- Being in an emergency or life-threatening situation
- Under court protection
- Pregnancy or breastfeeding
- Currently in an exclusion period from another study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67000
Actively Recruiting
Research Team
F
Fréderic BLANC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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