NCT05138588 Personalized Repetitive Transcranial Magnetic Stimulation (rTMS) in Cognitive Fluctuations of Dementia With Lewy Bodies (DLB): Proof of Concept
| NCT ID | NCT05138588 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Dementia With Lewy Bodies Diagnosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-02-02 |
| Primary Completion | 2028-02 |
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 40 participants in total. It began in 2022-02-02 with a primary completion date of 2028-02.
⚠ 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
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 Criteria
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)
Contact & Investigator
Frédéric BLANC
PRINCIPAL INVESTIGATOR
Hôpitaux Universitaires de Strasbourg
Frequently Asked Questions
Who can join the NCT05138588 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Dementia With Lewy Bodies Diagnosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05138588 currently recruiting?
Yes, NCT05138588 is actively recruiting participants. Contact the research team at f.blanc@unistra.fr for enrollment information.
Where is the NCT05138588 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT05138588 clinical trial?
NCT05138588 is sponsored by University Hospital, Strasbourg, France. The principal investigator is Frédéric BLANC at Hôpitaux Universitaires de Strasbourg. The trial plans to enroll 40 participants.