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RECRUITING

NCT05138588

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

Sponsor: University Hospital, Strasbourg, France

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-02-02

Completion Date

2028-07

Last Updated

2025-08-08

Healthy Volunteers

Conditions

Dementia With Lewy Bodies Diagnosis Significant Cognitive Fluctuations in DLB

Interventions

DEVICE

rTMS

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).

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)

Locations (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, France