💬In plain words
What the trial is, and whether it could suit you
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 \
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Male or female patient aged ≥ 45 years
* Enrolled in a social health insurance scheme
* Diagnosed with probable DLB according to McKeith et al. criteria, 2017, or McKeith et al. 2020 criteria for the prodromal stage
* A Mini Mental State Examination (MMSE; Folstein et al., 1983) score ≥ to 18 in the last 6 months (prodromal stage or a major neurocognitive disorder (dementia syndrome) at moderate stage)
* MMSE score ≥ to 15 at the inclusion visit
* Presence of clinically significant cognitive fluctuations
* Caregivers of eligible patients do have to be able to stay with the patient for at least 4 hours a day, 3 days a week, and have to be able to provide requested information and accompany the patient to the certain visits.
* The patient must be able to understand the objectives and risks of the study and has to be able to give dated and signed informed consent. In the case of a designed guardian or curator, the guardian or curator will sign the consent.
* For women of childbearing age, effective contraception throughout the study is required
Exclusion criteria:
* History of generalized seizures (epilepsy)
* Pharmacological treatment for cognitive fluctuations in DLB with dose modifications that have taken place less than 2 months before the first visit of the protocol (anticholinesterase and neuroleptics)
* Anti-epileptic drug treatment "Keppra" (Levetiracetam)
* History of psychosis or severe depression unrelated to DLB
* History of brain surgery (tumour removal, electrode implantation, certain strokes as judged by the investigator, oedema...)
* Patients with any contraindication for MRI scans (claustrophobia, pacemaker, cochlear implant, mechanical heart valve, metallic prostheses, neurostimulators, other non-removably implanted electronic medical devices etc.)
* Subject unable to understand the aims and risks of the study and patients unable to give full informed consent
* Having a MMSE score \< to 18 in the last 6 months (prodromal stage or mild to moderate dementia)
* MMSE score \< to 15 at the inclusion visit
* Patients in an emergency or life-threatening situation
* Patients under court protection
* Pregnancy
* Breastfeeding
* Patients in exclusion period (determined by a previous or current study)
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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